TherapeuticsMD (TXMD) 10-Q 7 Nov 17 2017 Q3 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2017	Oct. 30, 2017
Document And Entity Information
Entity Registrant Name	TherapeuticsMD, Inc.
Entity Central Index Key	25,743
Document Type	10-Q
Trading Symbol	TXMD
Document Period End Date	Sep. 30, 2017
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity a Well-known Seasoned Issuer	No
Entity a Voluntary Filer	No
Entity's Reporting Status Current	Yes
Entity Filer Category	Large Accelerated Filer
Entity Common Stock, Shares Outstanding		216,429,642
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2,017

CONSOLIDATED BALANCE SHEETS (Un

CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($)	Sep. 30, 2017	Dec. 31, 2016
Current Assets:
Cash	$ 148,292,654	$ 131,534,101
Accounts receivable, net of allowance for doubtful accounts of $377,929 and $376,374, respectively	4,392,635	4,500,699
Inventory	1,293,517	1,076,321
Other current assets	3,001,777	2,299,052
Total current assets	156,980,583	139,410,173
Fixed assets, net	448,066	516,839
Other Assets:
Intangible assets, net	2,793,421	2,405,972
Security deposit	139,036	139,036
Total other assets	2,932,457	2,545,008
Total assets	160,361,106	142,472,020
Current Liabilities:
Accounts payable	4,199,369	7,358,514
Other current liabilities	6,677,232	7,624,085
Total current liabilities	10,876,601	14,982,599
Commitments and Contingencies - See Note 14
Stockholders' Equity:
Preferred stock - par value $0.001; 10,000,000 shares authorized; no shares issued and outstanding
Common stock - par value $0.001; 350,000,000 shares authorized; 216,429,642 and 196,688,222 issued and outstanding, respectively	216,430	196,688
Additional paid in capital	514,499,865	436,995,052
Accumulated deficit	(365,231,790)	(309,702,319)
Total stockholders' equity	149,484,505	127,489,421
Total liabilities and stockholders' equity	$ 160,361,106	$ 142,472,020

CONSOLIDATED BALANCE SHEETS (U3

CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - USD ($)	Sep. 30, 2017	Dec. 31, 2016
Statement of Financial Position [Abstract]
Allowance for doubtful accounts	$ 377,929	$ 376,374
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, authorized	10,000,000	10,000,000
Preferred stock, issued	0	0
Preferred stock, outstanding	0	0
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, authorized	350,000,000	350,000,000
Common stock, issued	216,429,642	196,688,222
Common stock, outstanding	216,429,642	196,688,222

CONSOLIDATED STATEMENTS OF OPER

CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016
Income Statement [Abstract]
Revenues, net	$ 4,417,598	$ 5,535,685	$ 12,653,495	$ 14,869,023
Cost of goods sold	700,814	1,237,446	2,042,174	3,475,997
Gross profit	3,716,784	4,298,239	10,611,321	11,393,026
Operating expenses:
Sales, general, and administration	12,057,868	14,721,710	43,524,412	35,019,268
Research and development	6,436,802	14,664,123	22,878,037	43,602,333
Depreciation and amortization	54,055	40,460	156,943	84,319
Total operating expense	18,548,725	29,426,293	66,559,392	78,705,920
Operating loss	(14,831,941)	(25,128,054)	(55,948,071)	(67,312,894)
Other income:
Miscellaneous income	167,300	109,942	442,322	265,879
Accreted interest		2,451	7,699	7,850
Total other income	167,300	112,393	450,021	273,729
Loss before taxes	(14,664,641)	(25,015,661)	(55,498,050)	(67,039,165)
Net loss	$ (14,664,641)	$ (25,015,661)	$ (55,498,050)	$ (67,039,165)
Net loss per share, basic and diluted (in dollars per share)	$ (0.07)	$ (0.13)	$ (0.27)	$ (0.34)
Weighted average number of common shares outstanding (in shares)	207,938,338	196,502,327	203,282,335	195,912,173

CONSOLIDATED STATEMENTS OF CASH

CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)	9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$ (55,498,050)	$ (67,039,165)
Adjustments to reconcile net loss to net cash flows used in operating activities:
Depreciation of fixed assets	104,622	45,759
Amortization of intangible assets	52,321	38,560
Provision for doubtful accounts	1,555	2,261,568
Share-based compensation	5,037,783	13,385,215
Changes in operating assets and liabilities:
Accounts receivable	106,509	(4,245,151)
Inventory	(217,196)	(153,245)
Other current assets	(831,623)	379,930
Accounts payable	(3,159,145)	1,098,245
Other current liabilities	(946,853)	703,895
Net cash used in operating activities	(55,350,077)	(53,524,389)
CASH FLOWS FROM INVESTING ACTIVITIES
Patent costs	(439,770)	(541,686)
Purchase of fixed assets	(35,849)	(307,714)
Payment of security deposit		(14,036)
Net cash used in investing activities	(475,619)	(863,436)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from sale of common stock, net of costs	68,572,635	134,863,475
Proceeds from exercise of warrants	3,798,999	1,373,000
Proceeds from exercise of options	212,615	979,060
Net cash provided by financing activities	72,584,249	137,215,535
Increase in cash	16,758,553	82,827,710
Cash, beginning of period	131,534,101	64,706,355
Cash, end of period	$ 148,292,654	$ 147,534,065

THE COMPANY

THE COMPANY	9 Months Ended
	Sep. 30, 2017
Organization, Consolidation and Presentation of Financial Statements [Abstract]
THE COMPANY	NOTE 1 – THE COMPANY TherapeuticsMD, Inc., a Nevada corporation, or TherapeuticsMD, or the Company, has three wholly owned subsidiaries, vitaMedMD, LLC, a Delaware limited liability company, or VitaMed; BocaGreenMD, Inc., a Nevada corporation, or BocaGreen; and VitaCare Prescription Services, Inc., a Florida corporation, or VitaCare. Unless the context otherwise requires, TherapeuticsMD, VitaMed, BocaGreen, and VitaCare collectively are sometimes referred to as “our company,” “we,” “our,” or “us.” Nature of Business We are a women’s health care company focused on creating and commercializing products targeted exclusively for women. Currently, we are focused on pursuing the regulatory approvals and pre-commercialization activities necessary for commercialization of our advanced hormone therapy pharmaceutical products. Our drug candidates that have completed clinical trials are designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies, including hot flashes, osteoporosis and vaginal discomfort. We are developing these hormone therapy drug candidates, which contain estradiol and progesterone alone or in combination, with the aim of demonstrating clinical efficacy at lower doses, thereby enabling an enhanced side effect profile compared with competing products. With our SYMBODA™ technology, we are developing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. In addition, we manufacture and distribute branded and generic prescription prenatal vitamins, as well as over-the-counter, or OTC, iron supplements.

BASIS OF PRESENTATION AND RECEN

BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS	9 Months Ended
	Sep. 30, 2017
Basis Of Presentation And Recently Issued Accounting Pronouncements
BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS	NOTE 2 – BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS Interim Financial Statements The accompanying unaudited interim consolidated financial statements of TherapeuticsMD, Inc., which include our wholly owned subsidiaries, should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the Securities and Exchange Commission, or the SEC, from which we derived the accompanying consolidated balance sheet as of December 31, 2016. The accompanying unaudited interim consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP , for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, since they are interim statements, the accompanying unaudited interim consolidated financial statements do not include all of the information and notes required by GAAP for complete financial statements. The accompanying unaudited interim consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, that are, in the opinion of our management, necessary to a fair statement of the results for the interim periods presented. Interim results are not necessarily indicative of results for a full year or any other interim period in the future. Recently Issued Accounting Pronouncements In May 2017, the Financial Accounting Standards Board, or FASB, issued an Accounting Standards Update, or ASU, that clarifies when changes to the terms or conditions of a share-based payment award must be accounted for as modifications. The new guidance will reduce diversity in practice and result in fewer changes to the terms of an award being accounted for as modifications. The new guidance will allow companies to make certain changes to awards without accounting for them as modifications. This guidance does not change the accounting for modifications. The guidance will be applied prospectively to awards modified on or after the adoption date and is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2017. Early adoption is permitted, including in an interim period. We do not expect that adoption of this guidance will have a material effect on our consolidated financial statements. In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230). ASU 2016-15 is intended to reduce the diversity in practice regarding how certain transactions are classified within the statement of cash flows. ASU 2016-15 is effective for public business entities for annual periods beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption is permitted with retrospective application. We do not expect that adoption of this guidance will have a material effect on our consolidated financial statements. In March 2016, the FASB issued ASU 2016-09, Compensation – Stock Compensation: Improvements to Employee Share-Based Payment Accounting. This guidance simplifies several aspects of the accounting for employee share-based payment transactions for both public and nonpublic entities, including the accounting for income taxes, forfeitures, and statutory tax withholding requirements, as well as classification in the statement of cash flows. The guidance is effective for public business entities for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years. We adopted ASU 2016-09 effective January 1, 2017, electing to account for forfeitures when they occur. The impact from adoption of the provisions related to forfeiture rates was reflected in our consolidated financial statements on a modified retrospective basis, resulting in an adjustment of approximately $31,000 to retained earnings. The impact from adoption of the provisions related to excess tax benefits or deficiencies in the provision for income taxes rather than paid-in capital was adopted on a modified retrospective basis. Since we have a full valuation allowance on our net deferred tax assets, an amount equal to the cumulative adjustment made to retained earnings to recognize the previously unrecognized net operating losses from prior periods was made to the valuation allowance through retained earnings for the first quarter financial statements. Adoption of all other changes did not have an impact on our consolidated financial statements. In February 2016, the FASB issued ASU 2016-02, Leases. This guidance requires lessees to record most leases on their balance sheets but recognize expenses on their income statements in a manner similar to current accounting. The guidance also eliminates current real estate-specific provisions for all entities. For lessors, the guidance modifies the classification criteria and the accounting for sales-type and direct financing leases. The standard is effective for public business entities for annual periods beginning after December 15, 2018, and interim periods within those years. Early adoption is permitted for all entities. We are in the process of analyzing the quantitative impact of this guidance on our results of operations and financial position. While we are continuing to assess all potential impacts of the standard, we currently believe the impact of this standard will be primarily related to the accounting for our operating lease. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). The standard’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In doing so, companies will need to use more judgment and make more estimates than under previous guidance. This may include identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. In July 2015, the FASB approved the proposal to defer the effective date of ASU 2014-09 standard by one year. Early adoption is permitted after December 15, 2016, and the standard is effective for public entities for annual reporting periods beginning after December 15, 2017 and interim periods therein. In 2016, the FASB issued final amendments to clarify the implementation guidance for principal versus agent considerations (ASU 2016-08), accounting for licenses of intellectual property and identifying performance obligations (ASU 2016-10), narrow-scope improvements and practical expedients (ASU 2016-12) and technical corrections and improvements to topic 606 (ASU 2016-20) in its new revenue standard. We have performed a preliminary review of the requirements of the new revenue standard and are monitoring the activity of the FASB and the transition resource group as it relates to specific interpretive guidance. We have reviewed customer contracts and applied the five-step model of the new standard to our contracts as well as compared the results to our current accounting practices. We are currently in the process of drafting disclosures required by the new standard. At this point of our analysis, we do not believe that the adoption of this standard will have a material effect on our financial statements but will potentially expand our disclosures related to contracts with customers.

SUMMARY OF SIGNIFICANT ACCOUNTI

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	9 Months Ended
	Sep. 30, 2017
Accounting Policies [Abstract]
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Fair Value of Financial Instruments Our financial instruments consist primarily of cash, accounts receivable, accounts payable and accrued expenses. The carrying amount of cash, accounts receivable, accounts payable and accrued expenses approximates their fair value because of the short-term maturity of such instruments, which are considered Level 1 assets under the fair value hierarchy. We categorize our assets and liabilities that are valued at fair value on a recurring basis into a three-level fair value hierarchy as defined by Accounting Standards Codification, or ASC, 820, Fair Value Measurements . Level 1 unadjusted quoted prices in active markets for identical assets or liabilities; Level 2 quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument; and Level 3 unobservable inputs for the asset or liability. At September 30, 2017 and 2016, we had no assets or liabilities that were valued at fair value on a recurring basis. The fair value of indefinite-lived assets or long-lived assets is measured on a non-recurring basis using significant unobservable inputs (Level 3) in connection with our impairment test. There was no impairment of intangible assets or long-lived assets during the three and nine months ended September 30, 2017 and 2016. Trade Accounts Receivable and Allowance for Doubtful Accounts Trade accounts receivable are customer obligations due under normal trade terms. We review accounts receivable for uncollectible accounts and credit card charge-backs and provide an allowance for doubtful accounts, which is based upon a review of outstanding receivables, historical collection information, and existing economic conditions. We consider trade accounts receivable past due for more than 90 days to be delinquent. We write off delinquent receivables against our allowance for doubtful accounts based on individual credit evaluations, the results of collection efforts, and specific circumstances of customers. We record recoveries of accounts previously written off when received as an increase in the allowance for doubtful accounts. To the extent data we use to calculate these estimates does not accurately reflect bad debts, adjustments to these reserves may be required. Revenue Recognition We recognize revenue on arrangements in accordance with ASC 605, Revenue Recognition. We recognize revenue only when the price is fixed or determinable, persuasive evidence of an arrangement exists, the service is performed, and collectability is reasonably assured. Our OTC and prescription prenatal vitamin products are generally variations of the same product with slight modifications in formulation and marketing. The primary difference between our OTC and prescription prenatal vitamin products is the source of payment. Purchasers of our OTC prenatal vitamin products pay for the product directly while purchasers of our prescription prenatal vitamin products pay for the product primarily via third-party payers. Both OTC and prescription prenatal vitamin products share the same marketing support team utilizing similar marketing techniques. As of January 1, 2017, we ceased manufacturing and distributing our OTC product lines, except for Iron 21/7, which have declined steadily over time resulting in immaterial sales. The revenue that is generated by us from major customers is all generated from sales of our prescription prenatal vitamin products which is disclosed in Note 13. There are no major customers for our OTC prenatal vitamin or other products. Over-the-Counter Products We generate OTC revenue from product sales primarily to retail consumers. We recognize revenue from product sales upon shipment, when the rights of ownership and risk of loss have passed to the consumer. We include outbound shipping and handling fees, if any, in revenues, net, and bill them upon shipment. We include shipping expenses in cost of goods sold. A majority of our OTC customers pay for our products with credit cards, and we usually receive the cash settlement in two to three banking days. Credit card sales minimize accounts receivable balances relative to OTC sales (Iron 21/7). We provide an unconditional 30-day money-back return policy under which we accept product returns from our retail and eCommerce OTC customers. We recognize revenue from OTC sales, net of estimated returns and sales discounts. As of January 1, 2017, we ceased manufacturing and distributing our OTC product lines, except for Iron 21/7, which have declined steadily over time resulting in immaterial sales. Prescription Products We sell our name brand and generic prescription products primarily through wholesale distributors and retail pharmacy distributors. We recognize revenue from prescription product sales, net of sales discounts, chargebacks, wholesaler fees, customer rebates and estimated returns. Revenue related to prescription products sold through wholesale distributors is recognized when the prescription products are shipped to the distributors and the control of the products passes to each distributor. We accept returns of unsalable prescription products sold through wholesale distributors within a return period of six months prior to and up to 12 months following product expiration. Our prescription products currently have a shelf life of 24 months from the date of manufacture. Prior to September 1, 2016, we recognized revenue related to prescription products sold through retail pharmacy distributors when the product was dispensed by the retail pharmacy distributor, at which point all revenue and discounts related to such product were known or determinable and there was no right of return with respect to such product. On September 1, 2016, we centralized the distribution channel for both our retail pharmacy distributors and wholesale distributors, in order to facilitate sales to a broader population of retail pharmacies and mitigate exposure to any one retail pharmacy. Beginning on September 1, 2016, all of our prescription products are distributed under the wholesale distributor model described above. We offer various rebate programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. We estimate the allowance for consumer rebates and coupons that we have offered based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis. We record distributor fees based on amounts stated in contracts and estimate chargebacks based on the number of units sold each period. Share-Based Compensation We measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize the costs in the financial statements over the period during which employees are required to provide services. Share-based compensation arrangements may include options, restricted stock, restricted stock units, performance-based awards, and share appreciation rights. We amortize such compensation amounts, if any, over the respective service periods of the award. We use the Black-Scholes-Merton option pricing model, or the Black-Scholes Model, an acceptable model in accordance with ASC 718, Compensation-Stock Compensation, to value options. Option valuation models require the input of assumptions, including the expected life of the stock-based awards, the estimated stock price volatility, the risk-free interest rate, and the expected dividend yield. The risk-free interest rate assumption is based upon observed interest rates on zero coupon U.S. Treasury bonds whose maturity period is appropriate for the term of the instrument. Estimated volatility is a measure of the amount by which our stock price is expected to fluctuate each year during the term of the award. Prior to January 1, 2017, the expected volatility of share options was estimated based on a historical volatility analysis of peer entities whose stock prices were publicly available that were similar to our company with respect to industry, stage of life cycle, market capitalization, and financial leverage. On January 1, 2017, we started using our own stock price in our volatility calculation along with two other peer entities whose stock prices were publicly available that were similar to our company. Our calculation of estimated volatility is based on historical stock prices over a period equal to the expected term of the awards. The average expected life of warrants is based on the contractual terms of the awards. The average expected life of options is based on the contractual terms of the stock option using the simplified method. We utilize a dividend yield of zero based on the fact that we have never paid cash dividends and have no current intention to pay cash dividends. Calculating share-based compensation expense requires the input of highly subjective judgment and assumptions, estimates of expected life of the share-based award, stock price volatility and risk-free interest rates. The assumptions used in calculating the fair value of share-based awards represent our best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and we use different assumptions, our share-based compensation expense could be materially different in the future. Equity instruments (“instruments”) issued to non-employees are recorded on the basis of the fair value of the instruments, as required by ASC 505, Equity - Based Payments to Non-Employees, or ASC 505. ASC 505 defines the measurement date and recognition period for such instruments. In general, the measurement date is when either (a) a performance commitment, as defined, is reached or (b) the earlier of (i) the non-employee performance is complete or (ii) the instruments are vested. The estimated expense is recognized each period based on the current fair value of the award. As a result, the amount of expense related to awards to non-employees can fluctuate significantly during the period from the date of the grant through the final measurement date. The measured value related to the instruments is recognized over a period based on the facts and circumstances of each particular grant as defined in ASC 505. We recognize the compensation expense for all share-based compensation granted based on the grant date fair value estimated in accordance with ASC 718. We generally recognize the compensation expense on a straight-line basis over the employee’s requisite service period. We adopted ASU 2016-09, effective January 1, 2017, electing to account for forfeitures when they occur. Prior to that, Research and Development Expenses Research and development, or R&D, expenses include internal R&D activities, services of external contract research organizations, or CROs, costs of their clinical research sites, manufacturing, laboratory supplies, scale-up and validation costs, and other activities. Internal R&D activity expenses include salaries, benefits, and non-cash share-based compensation expenses. Advance payments to be expensed in future research and development activities are capitalized, and were $0 at September 30, 2017 and $228,933 at December 31, 2016, all of which were included in other current assets on the accompanying consolidated balance sheets. CRO activity expenses include preclinical laboratory experiments and clinical trial studies. Other activity expenses include regulatory consulting and legal fees and costs. The activities undertaken by our regulatory consultants that were classified as R&D expenses include assisting, consulting with, and advising our in-house staff with respect to various U.S. Food and Drug Administration, or the FDA, submission processes, clinical trial processes, and scientific writing matters, including preparing protocols and FDA submissions. Legal activities include professional research and advice regarding R&D, patents and regulatory matters. These consulting and legal expenses were direct costs associated with preparing, reviewing, and undertaking work for our clinical trials and investigative drugs. We charge internal R&D activities and other activity expenses to operations as incurred. We make payments to CROs based on agreed-upon terms, which may include payments in advance of a study starting date. We expense nonrefundable advance payments for goods and services that will be used in future R&D activities when the activity has been performed or when the goods have been received rather than when the payment is made. We review and accrue CRO expenses and clinical trial study expenses based on services performed and rely on estimates of those costs applicable to the completion stage of a study as provided by CROs. Estimated accrued CRO costs are subject to revisions as such studies progress to completion. We charge revisions expense in the period in which the facts that give rise to the revision become known. Segment Reporting We are managed and operated as one business, which is focused on creating and commercializing products targeted exclusively for women. Our business operations are managed by a single management team that reports to the President of our company. We do not operate separate lines of business with respect to any of our products and we do not prepare discrete financial information with respect to separate products. All product sales are derived from sales in the United States. Accordingly, we view our business as one reportable operating segment.

INVENTORY

INVENTORY	9 Months Ended
	Sep. 30, 2017
Inventory Disclosure [Abstract]
INVENTORY	NOTE 4 – INVENTORY Inventory consists of the following: September 30, 2017 December 31, 2016 Finished product $ 1,293,517 $ 1,062,285 Raw material — 14,036 TOTAL INVENTORY $ 1,293,517 $ 1,076,321

OTHER CURRENT ASSETS

OTHER CURRENT ASSETS	9 Months Ended
	Sep. 30, 2017
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
OTHER CURRENT ASSETS	NOTE 5 – OTHER CURRENT ASSETS Other current assets consist of the following: September 30, 2017 December 31, 2016 Prepaid manufacturing costs $ 999,508 $ 991,809 Prepaid sales and marketing costs 535,936 — Prepaid insurance 953,792 628,039 Prepaid research and development costs — 100,035 Prepaid consulting — 128,898 Prepaid vendor deposits 5,000 44,311 Other prepaid costs 507,541 405,960 TOTAL OTHER CURRENT ASSETS $ 3,001,777 $ 2,299,052

FIXED ASSETS

FIXED ASSETS	9 Months Ended
	Sep. 30, 2017
Property, Plant and Equipment [Abstract]
FIXED ASSETS	NOTE 6 – FIXED ASSETS Fixed assets consist of the following: September 30, 2017 December 31, 2016 Accounting system $ 301,096 $ 301,096 Equipment 247,568 215,182 Computer hardware 80,211 80,211 Furniture and fixtures 116,542 113,079 Leasehold improvements 37,888 37,888 783,305 747,456 Accumulated depreciation (335,239 ) (230,617 ) TOTAL FIXED ASSETS $ 448,066 $ 516,839 Depreciation expense for the three months ended September 30, 2017 and 2016 was $35,622 and $26,543 respectively, and $104,622 and $45,759 for the nine months ended September 30, 2017 and 2016, respectively.

INTANGIBLE ASSETS

INTANGIBLE ASSETS	9 Months Ended
	Sep. 30, 2017
Intangible Assets, Net (Excluding Goodwill) [Abstract]
INTANGIBLE ASSETS	NOTE 7 – INTANGIBLE ASSETS The following table sets forth the gross carrying amount and accumulated amortization of our intangible assets as of September 30, 2017 and December 31, 2016: September 30, 2017 Gross Carrying Amount Accumulated Amortization Net Amount Weighted- Average Remaining Amortization Amortizing intangible assets: OPERA ® $ 31,951 $ (7,988 ) $ 23,963 12 Development costs of corporate website 91,743 (91,743 ) — n/a Approved hormone therapy drug candidate patents 1,247,181 (153,216 ) 1,093,965 15.25 Hormone therapy drug candidate patents (pending) 1,474,061 — 1,474,061 n/a Non-amortizing intangible assets: Multiple trademarks 201,432 — 201,432 indefinite Total $ 3,046,368 $ (252,947 ) $ 2,793,421 December 31, 2016 Gross Carrying Amount Accumulated Amortization Net Amount Weighted- Average Remaining Amortization Amortizing intangible assets: OPERA ® $ 31,951 $ (6,490 ) $ 25,461 12.75 Development costs of corporate website 91,743 (91,743 ) — n/a Approved hormone therapy drug candidate patents 1,093,452 (102,393 ) 991,059 16 Hormone therapy drug candidate patents (pending) 1,203,987 — 1,203,987 n/a Non-amortizing intangible assets: Multiple trademarks 185,465 — 185,465 indefinite Total $ 2,606,598 $ (200,626 ) $ 2,405,972 We capitalize external costs, consisting primarily of legal costs, related to securing our patents and trademarks. Once a patent is granted, we amortize the approved hormone therapy drug candidate patents using the straight-line method over the estimated useful life of approximately 20 years, which is the life of intellectual property patents. If the patent is not granted, we write-off any capitalized patent costs at that time. Trademarks are perpetual and are not amortized. During the nine months ended September 30, 2017 and year ended December 31, 2016, there was no impairment recognized related to intangible assets. In addition to numerous pending patent applications, as of September 30, 2017, we had 17 issued patents, including: ● 13 utility patents that relate to our combination progesterone and estradiol product candidates, which are owned by us and are U.S. jurisdiction patents with expiration dates in 2032. We have pending patent applications with respect to certain of these patents in Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, Russia, South Africa, and South Korea. ● two utility patents that relate to TX-004HR, our applicator-free vaginal estradiol softgel product candidate, which establishes an important intellectual property foundation for TX-004HR, which are owned by us and are U.S. jurisdiction patents with an expiration date in 2033. We have pending patent applications with respect to certain of these patents in Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, Russia, South Africa, and South Korea. ● one utility patent that relates to a pipeline transdermal patch technology, which is owned by us and is a U.S. jurisdiction patent with an expiration in 2032. We have pending patent application with respect to this patent in Australia, Brazil, Canada, Europe, Mexico, and Japan. ● one utility patent that relates to our OPERA® information technology platform, which is owned by us and is a U.S. jurisdiction patent with an expiration date in 2029. Amortization expense was $18,433 and $13,917 for the three months ended September 30, 2017 and 2016, respectively, and $52,321 and $38,560 for the nine months ended September 30, 2017 and 2016, respectively. Estimated amortization expense for the next five years for the patent cost currently being amortized is as follows: Year Ending Estimated 2017(3 months) $ 18,433 2018 $ 73,732 2019 $ 73,732 2020 $ 73,732 2021 $ 73,732 Thereafter $ 804,567

OTHER CURRENT LIABILITIES

OTHER CURRENT LIABILITIES	9 Months Ended
	Sep. 30, 2017
Other Liabilities Disclosure [Abstract]
OTHER CURRENT LIABILITIES	NOTE 8 – OTHER CURRENT LIABILITIES Other current liabilities consist of the following: September 30, 2017 December 31, 2016 Accrued clinical trial costs $ 556,048 $ 1,281,080 Accrued payroll, bonuses and commission costs 2,662,359 3,531,440 Accrued compensated absences 952,587 665,561 Accrued legal and accounting expense 366,828 176,518 Accrued sales and marketing costs 69,041 665,773 Other accrued expenses 319,015 224,865 Allowance for wholesale distributor fees 145,563 76,510 Accrued royalties 93,870 26,507 Allowance for coupons and returns 1,218,249 794,816 Accrued rent 293,672 181,015 TOTAL OTHER CURRENT LIABILITIES $ 6,677,232 $ 7,624,085

NET LOSS PER SHARE

NET LOSS PER SHARE	9 Months Ended
	Sep. 30, 2017
Earnings Per Share [Abstract]
NET LOSS PER SHARE	NOTE 9 – NET LOSS PER SHARE We calculate earnings per share, or EPS, in accordance with ASC 260, Earnings Per Share, which requires the computation and disclosure of two EPS amounts: basic and diluted. We compute basic EPS based on the weighted-average number of shares of common stock, par value $0.001 per share, or Common Stock, outstanding during the period. We compute diluted EPS based on the weighted-average number of shares of Common Stock outstanding plus all potentially dilutive shares of Common Stock outstanding during the period. Such potentially dilutive shares of Common Stock consist of options and warrants and were excluded from the calculation of diluted earnings per share because their effect would have been anti-dilutive due to the net loss reported by us. The table below presents potentially dilutive securities that could affect our calculation of diluted net loss per share allocable to common stockholders for the periods presented. Nine Months Ended 2017 2016 Stock options 23,383,100 20,705,923 Warrants 3,115,905 12,060,571 26,499,005 32,766,494

STOCKHOLDERS' EQUITY

STOCKHOLDERS' EQUITY	9 Months Ended
	Sep. 30, 2017
Stockholders' Equity:
STOCKHOLDERS' EQUITY	NOTE 10 – STOCKHOLDERS’ EQUITY Preferred Stock At September 30, 2017, we had 10,000,000 shares of preferred stock, par value $0.001, authorized for issuance, of which no shares of preferred stock were issued or outstanding. Common Stock At September 30, 2017, we had 350,000,000 shares of Common Stock authorized for issuance, of which 216,429,642 shares of Common Stock were issued and outstanding. Issuances During 2017 On September 25, 2017, we entered into an underwriting agreement with J.P. Morgan Securities LLC relating to an underwritten public offering of 12,400,000 shares of our Common Stock at a price of $5.55 per share. The net proceeds to us from the offering were approximately $68,573,000, after deducting estimated offering expenses payable by us. The offering closed on September 28, 2017 and we issued 12,400,000 shares of Common Stock. During the three months ended September 30, 2017, certain individuals exercised stock options to purchase 2,500 shares of Common Stock for $255 in cash. During the nine months ended September 30, 2017, certain individuals exercised stock options to purchase 102,546 shares of Common Stock for $212,615 in cash. Issuances During 2016 On January 6, 2016, we entered into an underwriting agreement with Goldman Sachs & Co. and Cowen and Company, LLC, as the representatives of the several underwriters, or the Underwriters, relating to an underwritten public offering of 15,151,515 shares of Common Stock at a public offering price of $8.25 per share. Under the terms of the underwriting agreement, we granted the Underwriters a 30-day option to purchase up to an aggregate of 2,272,727 additional shares of Common Stock, which option was exercised in full. The net proceeds to us from the offering were approximately $134,864,000, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us. The offering closed on January 12, 2016 and we issued 17,424,242 shares of Common Stock. During the three months ended September 30, 2016, certain individuals exercised stock options to purchase 127,109 shares of Common Stock. Stock options to purchase shares of Common Stock were exercised as follows: (i) 10,000 options for $1,018 in cash and (ii) 117,109 options, pursuant to the stock options’ cashless provision, wherein 78,017 shares of Common Stock were issued. During the nine months ended September 30, 2016, certain individuals exercised stock options to purchase 544,277 shares of Common Stock. Stock options to purchase shares of Common Stock were exercised as follows: (i) 427,168 options for $979,060 in cash and (ii) 117,109 options, pursuant to the stock options’ cashless provision, wherein 78,017 shares of Common Stock were issued. Warrants to Purchase Common Stock As of September 30, 2017, we had warrants outstanding to purchase an aggregate of 3,115,905 shares of Common Stock with a weighted-average contractual remaining life of approximately 2.08 years, and exercise prices ranging from $0.24 to $8.20 per share, resulting in a weighted average exercise price of $2.58 per share. The valuation methodology used to determine the fair value of our warrants is the Black-Scholes Model. The Black-Scholes Model requires the use of a number of assumptions, including volatility of the stock price, the risk-free interest rate and the term of the warrant. During the nine months ended September 30, 2017, we granted warrants to purchase 125,000 shares of Common Stock to outside consultants at an exercise price of $6.83 per share. The fair value for these warrants was determined by using the Black-Scholes Model on the date of the grant using a term of five years; volatility of 63.24%; risk free rate of 1.47%; and dividend yield of 0%. The grant date fair value of the warrants was $3.67 per share. The warrants are vesting ratably over a 12-month period and have an expiration date of March 15, 2022. During the nine months ended September 30, 2016, we granted warrants to purchase 245,000 shares of Common Stock to outside consultants at a weighted average exercise price of $7.90 per share. The weighted average grant date fair value of these warrants was $4.78 per share. The fair value for these warrants was determined by using the Black-Scholes Model on the date of the grant using a term of five years; volatility of 74.10%-74.15%; risk free rate of 1.04%-1.28%; and dividend yield of 0%. These warrants vest and have expiration dates as follows: warrants to purchase 75,000 shares of Common Stock vested on April 21, 2016 and have an expiration date of April 21, 2021, warrants to purchase 50,000 shares of Common Stock vest ratably over a 24-month period and have an expiration date of April 21, 2021, and warrants to purchase 120,000 shares of Common Stock vest ratable over a 12-month period and have an expiration date of January 21, 2021. During the three months ended September 30, 2017 and 2016, we recorded $101,376 and $137,161, respectively, and during the nine months ended September 30, 2017 and 2016 we recorded $217,150 and $820,751, respectively, as share-based compensation expense in the accompanying consolidated financial statements related to warrants. As of September 30, 2017, unamortized costs associated with these warrants totaled approximately $279,000. In May 2013, we entered into a consulting agreement with Sancilio and Company, Inc., or SCI, to develop drug platforms to be used in our hormone replacement drug candidates. These services include support of our efforts to successfully obtain FDA approval for our drug candidates, including a vaginal capsule for the treatment of vulvar and vaginal atrophy, or VVA. In connection with the agreement, SCI agreed to forfeit its rights to receive warrants to purchase 833,000 shares of Common Stock that were to be granted pursuant to the terms of a prior consulting agreement dated May 17, 2012. As consideration under the agreement, we agreed to issue to SCI a warrant to purchase 850,000 shares of Common Stock at $2.01 per share that has vested or will vest, as applicable, as follows: 1. 283,333 shares were earned on May 11, 2013 upon acceptance of an Investigational New Drug application by the FDA for an estradiol based drug candidate in a softgel vaginal capsule for the treatment of VVA; however, pursuant to the terms of the consulting agreement, the shares did not vest until June 30, 2013. The fair value of $405,066 for the shares vested on June 30, 2013 was determined by using the Black-Scholes Model on the date of vesting using a term of 5 years; a volatility of 45.89%; risk free rate of 1.12%; and a dividend yield of 0%. We recorded the entire $405,066 as non-cash compensation as of June 30, 2013; 2. 283,333 shares vested on June 30, 2013. The fair value of $462,196 for these shares was determined by using the Black-Scholes Model on the date of vesting using a term of 5 years; a volatility of 45.84%; risk free rate of 1.41%; and a dividend yield of 0%. During both the three months ended September 30, 2017 and 2016, we did not record any non-cash compensation related to this warrant in the accompanying consolidated financial statements. During the nine months ended September 30, 2017 and 2016, we recorded $0 and $77,026, respectively, as non-cash compensation in the accompanying consolidated financial statements related to this warrant. As of June 30, 2016, this warrant was fully amortized; and 3. 283,334 shares will vest upon the receipt by us of any final FDA approval of a drug candidate that SCI helped us design. It is anticipated that this event will occur in the near future. In May 2012, we issued warrants to purchase an aggregate of 1,300,000 shares of Common Stock to SCI for services to be rendered over approximately five years beginning in May 2012. The warrants vested upon issuance. Services provided are to include (a) services in support of our drug development efforts, including services in support of our ongoing and future drug development and commercialization efforts, regulatory approval efforts, third-party investment and financing efforts, marketing efforts, chemistry, manufacturing and controls efforts, drug launch and post-approval activities, and other intellectual property and know-how transfer associated therewith; (b) services in support of our efforts to successfully obtain New Drug Approval; and (c) other consulting services as mutually agreed upon from time to time in relation to new drug development opportunities. The warrants were valued at $1,532,228 on the date of the issuance using an exercise price of $2.57; a term of five years; a volatility of 44.71%; risk free rate of 0.74%; and a dividend yield of 0%. During the three months ended September 30, 2017 and 2016, we recorded $0 and $64,449, respectively, and during the nine months ended September 30, 2017 and 2016, we recorded $128,898 and $193,347, respectively, as non-cash compensation expense with respect to these warrants in the accompanying consolidated statements of operations. The contract will expire upon the commercial manufacture of a drug product. As of September 30, 2017, the SCI warrants issued in 2013 and 2012 were fully amortized. During both the three months ended September 30, 2017 and 2016, no warrants were exercised. During the nine months ended September 30, 2017, certain individuals exercised warrants to purchase 2,476,666 shares of Common Stock for $3,798,999 in cash. In addition, during the nine months ended September 30, 2017, certain individuals exercised warrants to purchase 6,590,000 shares of Common Stock pursuant to the warrants’ cashless exercise provisions, wherein 4,762,208 shares of Common Stock were issued. During the nine months ended September 30, 2016, certain individuals exercised warrants to purchase 722,744 shares of Common Stock for $1,373,000 in cash. Options to Purchase Common Stock In 2009, we adopted the 2009 Long Term Incentive Compensation Plan, or the 2009 Plan, to provide financial incentives to employees, directors, advisers, and consultants of our company who are able to contribute towards the creation of or who have created stockholder value by providing them stock options and other stock and cash incentives, or the Awards. The Awards available under the 2009 Plan consist of stock options, stock appreciation rights, restricted stock, restricted stock units, performance stock, performance units, and other stock or cash awards as described in the 2009 Plan. There are 25,000,000 shares authorized for issuance thereunder. Generally, the options vest annually over four years or as determined by our board of directors, upon each option grant. Options may be exercised by paying the price for shares or on a cashless exercise basis after they have vested and prior to the specified expiration date provided and applicable exercise conditions are met, if any. The expiration date is generally ten years from the date the option is issued. As of September 30, 2017, there were non-qualified stock options to purchase 18,592,959 shares of Common Stock outstanding under the 2009 Plan. As of September 30, 2017, there were 2,156,003 shares of Common Stock available to be issued under the 2009 Plan. In 2012, we adopted the 2012 Stock Incentive Plan, or the 2012 Plan, a non-qualified plan that was amended in August 2013. The 2012 Plan was designed to serve as an incentive for retaining qualified and competent key employees, officers, directors, and certain consultants and advisors of our company. The Awards available under the 2012 Plan consist of stock options, stock appreciation rights, restricted stock, restricted stock units, performance stock, performance units, and other stock or cash awards as described in the 2012 Plan. Generally, the options vest annually over four years or as determined by our board of directors, upon each option grant. Options may be exercised by paying the price for shares or on a cashless exercise basis after they have vested and prior to the specified expiration date provided and applicable exercise conditions are met, if any. The expiration date is generally ten years from the date the option is issued. There are 10,000,000 shares of Common Stock authorized for issuance thereunder. As of September 30, 2017, there were non-qualified stock options to purchase 4,790,141 shares of Common Stock outstanding under the 2012 Plan. As of September 30, 2017, there were 5,128,333 shares of Common Stock available to be issued under the 2012 Plan. The valuation methodology used to determine the fair value of stock options is the Black-Scholes Model. The Black-Scholes Model requires the use of a number of assumptions including volatility of the stock price, the risk-free interest rate, and the expected life of the stock options. The assumptions used in the Black-Scholes Model for options granted during the nine months ended September 30, 2017 and 2016 are set forth in the table below. Nine Months Ended September 30, September 30, Risk-free interest rate 1.84-2.01% 1.13-1.70% Volatility 61.56-63.95% 70.26-71.22% Term (in years) 5.5-6.25 6.00-6.25 Dividend yield 0.00% 0.00% A summary of activity under the 2009 and 2012 Plans and related information follows: Number of Shares Underlying Stock Options Weighted Average Exercise Price Weighted Aggregate Balance at December 31, 2016 21,767,854 $ 3.56 5.8 $ 60,495,730 Granted 2,184,500 $ 6.61 Exercised (102,546 ) $ 2.07 $ 452,287 Expired/Forfeited (466,708 ) $ 6.52 Balance at September 30, 2017 23,383,100 $ 3.79 5.4 $ 52,467,444 Vested and Exercisable at September 30, 2017 18,883,183 $ 3.15 4.6 $ 52,059,288 Unvested at September 30, 2017 4,499,917 $ 6.46 8.6 $ 408,156 At September 30, 2017, our outstanding stock options had exercise prices ranging from $0.10 to $8.92 per share. The weighted average grant date fair value per share of options granted was $3.82 and $4.70 during the nine months ended September 30, 2017 and 2016, respectively. Share-based compensation expense for options recognized in our results of operations is based on vested awards. Share-based compensation expense related to options for the three months ended September 30, 2017 and 2016 was $1,885,050 and $3,982,759, respectively, and for the nine months ended September 30, 2017 and 2016 was $4,691,735 and $12,294,089, respectively. At September 30, 2017, total unrecognized estimated compensation expense related to unvested options granted prior to that date was approximately $12,419,000. This cost is expected to be recognized over a weighted-average period of 2.2 years. No tax benefit was realized due to a continued pattern of operating losses.

INCOME TAXES

INCOME TAXES	9 Months Ended
	Sep. 30, 2017
Income Tax Disclosure [Abstract]
INCOME TAXES	NOTE 11 – INCOME TAXES Deferred income tax assets and liabilities are determined based upon differences between the financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. We do not expect to pay any significant federal or state income tax for 2017 as a result of (a) the losses recorded during the nine months ended September 30, 2017, (b) additional losses expected for the remainder of 2017, and/or (c) net operating loss carry forwards from prior years. Accounting standards require the consideration of a valuation allowance for deferred tax assets if it is “more likely than not” that some component or all of the benefits of deferred tax assets will not be realized. As of September 30, 2017, we maintain a full valuation allowance for all deferred tax assets. Based on these requirements, no provision or benefit for income taxes has been recorded. There were no recorded unrecognized tax benefits at the end of the reporting period.

RELATED PARTIES

RELATED PARTIES	9 Months Ended
	Sep. 30, 2017
Related Party Transactions [Abstract]
RELATED PARTIES	NOTE 12 – RELATED PARTIES In July 2015, J. Martin Carroll, a director of our company, was appointed to the board of directors of Catalent, Inc. From time to time, we have entered into agreements with Catalent, Inc. and its affiliates, or Catalent, in the normal course of business. Agreements with Catalent have been reviewed by independent directors of our company or a committee consisting of independent directors of our company since July 2015. During the three months ended September 30, 2017 and 2016, we were billed by Catalent approximately $186,000 and $828,000, respectively, for manufacturing activities related to our clinical trials, scale-up, registration batches, stability and validation testing. During the nine months ended September 30, 2017 and 2016, we were billed by Catalent approximately $2,646,000 and $2,907,000, respectively, for manufacturing activities related to our clinical trials, scale-up, registration batches, stability and validation testing. As of September 30, 2017 and December 31, 2016, there were amounts due to Catalent of approximately $26,000 and $57,000, respectively.

BUSINESS CONCENTRATIONS

BUSINESS CONCENTRATIONS	9 Months Ended
	Sep. 30, 2017
Risks and Uncertainties [Abstract]
BUSINESS CONCENTRATIONS	NOTE 13 - BUSINESS CONCENTRATIONS We purchase our products from several suppliers with approximately 100% and 97% of our purchases supplied from one vendor for both the three and nine months ended September 30, 2017 and 2016, respectively. We sell our prescription prenatal vitamin products to wholesale distributors, specialty pharmacies, specialty distributors, and chain drug stores that generally sell products to retail pharmacies, hospitals, and other institutional customers. As a result of developments in the pharmaceutical industry that negatively affected independent pharmacies, including such pharmacies’ reliance on third-party payors, in 2016, we identified that payment periods for our retail pharmacy distributors were becoming longer than in prior years. As a result, during the third quarter of 2016, we centralized the distribution channel for both our retail pharmacy distributors and wholesale distributors, in order to facilitate sales to a broader population of retail pharmacies and minimize business risk exposure to any one retail pharmacy. During the third quarter of 2016, we entered into new distribution agreements with our retail pharmacy distributors to effectuate this centralization which were effective September 1, 2016. During both the nine months ended September 30, 2017 and 2016, four customers each generated more than 10% of our total revenue. Revenue generated from four major customers combined accounted for approximately 60% of our revenue for both the nine months ended September 30, 2017 and 2016. During the nine months ended September 30, 2017, Pharmacy Innovations PA generated approximately $2,715,000 of our revenue, AmerisourceBergen generated approximately $1,716,000 of our revenue, Cardinal Health generated approximately $1,764,000 of our revenue and McKesson Corporation generated approximately $1,458,000 of our revenue. During the nine months ended September 30, 2016, Woodstock Pharmaceutical and Compounding generated approximately $2,247,000 of our revenue, Medical Center Pharmacy generated approximately $2,683,000 of our revenue, Due West Pharmacy generated approximately $1,890,000 of our revenue and Pharmacy Innovations generated approximately $2,113,000 of our revenue.

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES	9 Months Ended
	Sep. 30, 2017
Commitments and Contingencies Disclosure [Abstract]
COMMITMENTS AND CONTINGENCIES	NOTE 14– COMMITMENTS AND CONTINGENCIES Operating Lease We lease administrative office space in Boca Raton, Florida pursuant to a non-cancelable operating lease that commenced on July 1, 2013 and originally provided for a 63-month term. On February 18, 2015, we entered into an agreement with the same lessors to lease additional administrative office space in the same location, pursuant to an addendum to such lease. In addition, on April 26, 2016, we entered into an agreement with the same lessors to lease additional administrative office space in the same location. This agreement was effective beginning May 1, 2016 and extended the original expiration of the lease term to October 31, 2021. On October 4, 2016, we entered into an agreement with the same lessors to lease additional administrative office space in the same location, pursuant to an addendum to such lease. This addendum is effective beginning November 1, 2016. The rental expense related to our current lease during the three months ended September 30, 2017 and 2016 was approximately $257,000 and $182,000, respectively. The rental expense related to our current lease during the nine months ended September 30, 2017 and 2016 was approximately $772,000 and $482,000, respectively. As of September 30, 2017, future minimum rental payments on non-cancelable operating leases are as follows: Years Ending December 31, 2017 (3 months) $ 224,632 2018 951,194 2019 1,094,116 2020 1,113,069 2021 943,127 Total minimum lease payments $ 4,326,138 Legal Proceedings On April 17, 2017, a securities class action lawsuit was filed against our company and certain of our officers and directors in the U.S. District Court for the Southern District of Florida (Case No. 9:17-cv-80473-RLR) that purported to state a claim for alleged violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated thereunder, based on statements made by the defendants concerning the NDA for TX-004HR. The complaint sought unspecified damages, interest, attorneys’ fees and other costs. On July 18, 2017, the complaint was voluntarily dismissed by the lead plaintiff without prejudice. We and certain of our officers and directors were are also subject to two shareholder derivative lawsuits regarding the NDA for TX-004HR, one filed in the U.S. District Court for the Southern District of Florida on May 30, 2017 (Case No. 9:17-cv-80686-RLR) and one filed in Florida state court in Palm Beach County on June 5, 2017 (Case No. 502017CA006289XXXXMB). These complaints were both voluntarily dismissed by the lead plaintiffs without prejudice on August 14, 2017.

SUMMARY OF SIGNIFICANT ACCOUN20

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	9 Months Ended
	Sep. 30, 2017
Accounting Policies [Abstract]
Fair Value of Financial Instruments	Fair Value of Financial Instruments Our financial instruments consist primarily of cash, accounts receivable, accounts payable and accrued expenses. The carrying amount of cash, accounts receivable, accounts payable and accrued expenses approximates their fair value because of the short-term maturity of such instruments, which are considered Level 1 assets under the fair value hierarchy. We categorize our assets and liabilities that are valued at fair value on a recurring basis into a three-level fair value hierarchy as defined by Accounting Standards Codification, or ASC, 820, Fair Value Measurements . Level 1 unadjusted quoted prices in active markets for identical assets or liabilities; Level 2 quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument; and Level 3 unobservable inputs for the asset or liability. At September 30, 2017 and 2016, we had no assets or liabilities that were valued at fair value on a recurring basis. The fair value of indefinite-lived assets or long-lived assets is measured on a non-recurring basis using significant unobservable inputs (Level 3) in connection with our impairment test. There was no impairment of intangible assets or long-lived assets during the three and nine months ended September 30, 2017 and 2016.
Trade Accounts Receivable and Allowance for Doubtful Accounts	Trade Accounts Receivable and Allowance for Doubtful Accounts Trade accounts receivable are customer obligations due under normal trade terms. We review accounts receivable for uncollectible accounts and credit card charge-backs and provide an allowance for doubtful accounts, which is based upon a review of outstanding receivables, historical collection information, and existing economic conditions. We consider trade accounts receivable past due for more than 90 days to be delinquent. We write off delinquent receivables against our allowance for doubtful accounts based on individual credit evaluations, the results of collection efforts, and specific circumstances of customers. We record recoveries of accounts previously written off when received as an increase in the allowance for doubtful accounts. To the extent data we use to calculate these estimates does not accurately reflect bad debts, adjustments to these reserves may be required.
Revenue Recognition	Revenue Recognition We recognize revenue on arrangements in accordance with ASC 605, Revenue Recognition. We recognize revenue only when the price is fixed or determinable, persuasive evidence of an arrangement exists, the service is performed, and collectability is reasonably assured. Our OTC and prescription prenatal vitamin products are generally variations of the same product with slight modifications in formulation and marketing. The primary difference between our OTC and prescription prenatal vitamin products is the source of payment. Purchasers of our OTC prenatal vitamin products pay for the product directly while purchasers of our prescription prenatal vitamin products pay for the product primarily via third-party payers. Both OTC and prescription prenatal vitamin products share the same marketing support team utilizing similar marketing techniques. As of January 1, 2017, we ceased manufacturing and distributing our OTC product lines, except for Iron 21/7, which have declined steadily over time resulting in immaterial sales. The revenue that is generated by us from major customers is all generated from sales of our prescription prenatal vitamin products which is disclosed in Note 13. There are no major customers for our OTC prenatal vitamin or other products.
Over-the-Counter Products	Over-the-Counter Products We generate OTC revenue from product sales primarily to retail consumers. We recognize revenue from product sales upon shipment, when the rights of ownership and risk of loss have passed to the consumer. We include outbound shipping and handling fees, if any, in revenues, net, and bill them upon shipment. We include shipping expenses in cost of goods sold. A majority of our OTC customers pay for our products with credit cards, and we usually receive the cash settlement in two to three banking days. Credit card sales minimize accounts receivable balances relative to OTC sales (Iron 21/7). We provide an unconditional 30-day money-back return policy under which we accept product returns from our retail and eCommerce OTC customers. We recognize revenue from OTC sales, net of estimated returns and sales discounts. As of January 1, 2017, we ceased manufacturing and distributing our OTC product lines, except for Iron 21/7, which have declined steadily over time resulting in immaterial sales.
Prescription Products	Prescription Products We sell our name brand and generic prescription products primarily through wholesale distributors and retail pharmacy distributors. We recognize revenue from prescription product sales, net of sales discounts, chargebacks, wholesaler fees, customer rebates and estimated returns. Revenue related to prescription products sold through wholesale distributors is recognized when the prescription products are shipped to the distributors and the control of the products passes to each distributor. We accept returns of unsalable prescription products sold through wholesale distributors within a return period of six months prior to and up to 12 months following product expiration. Our prescription products currently have a shelf life of 24 months from the date of manufacture. Prior to September 1, 2016, we recognized revenue related to prescription products sold through retail pharmacy distributors when the product was dispensed by the retail pharmacy distributor, at which point all revenue and discounts related to such product were known or determinable and there was no right of return with respect to such product. On September 1, 2016, we centralized the distribution channel for both our retail pharmacy distributors and wholesale distributors, in order to facilitate sales to a broader population of retail pharmacies and mitigate exposure to any one retail pharmacy. Beginning on September 1, 2016, all of our prescription products are distributed under the wholesale distributor model described above. We offer various rebate programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. We estimate the allowance for consumer rebates and coupons that we have offered based on our experience and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis. We record distributor fees based on amounts stated in contracts and estimate chargebacks based on the number of units sold each period.
Share-Based Compensation	Share-Based Compensation We measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize the costs in the financial statements over the period during which employees are required to provide services. Share-based compensation arrangements may include options, restricted stock, restricted stock units, performance-based awards, and share appreciation rights. We amortize such compensation amounts, if any, over the respective service periods of the award. We use the Black-Scholes-Merton option pricing model, or the Black-Scholes Model, an acceptable model in accordance with ASC 718, Compensation-Stock Compensation, to value options. Option valuation models require the input of assumptions, including the expected life of the stock-based awards, the estimated stock price volatility, the risk-free interest rate, and the expected dividend yield. The risk-free interest rate assumption is based upon observed interest rates on zero coupon U.S. Treasury bonds whose maturity period is appropriate for the term of the instrument. Estimated volatility is a measure of the amount by which our stock price is expected to fluctuate each year during the term of the award. Prior to January 1, 2017, the expected volatility of share options was estimated based on a historical volatility analysis of peer entities whose stock prices were publicly available that were similar to our company with respect to industry, stage of life cycle, market capitalization, and financial leverage. On January 1, 2017, we started using our own stock price in our volatility calculation along with two other peer entities whose stock prices were publicly available that were similar to our company. Our calculation of estimated volatility is based on historical stock prices over a period equal to the expected term of the awards. The average expected life of warrants is based on the contractual terms of the awards. The average expected life of options is based on the contractual terms of the stock option using the simplified method. We utilize a dividend yield of zero based on the fact that we have never paid cash dividends and have no current intention to pay cash dividends. Calculating share-based compensation expense requires the input of highly subjective judgment and assumptions, estimates of expected life of the share-based award, stock price volatility and risk-free interest rates. The assumptions used in calculating the fair value of share-based awards represent our best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and we use different assumptions, our share-based compensation expense could be materially different in the future. Equity instruments (“instruments”) issued to non-employees are recorded on the basis of the fair value of the instruments, as required by ASC 505, Equity - Based Payments to Non-Employees, or ASC 505. ASC 505 defines the measurement date and recognition period for such instruments. In general, the measurement date is when either (a) a performance commitment, as defined, is reached or (b) the earlier of (i) the non-employee performance is complete or (ii) the instruments are vested. The estimated expense is recognized each period based on the current fair value of the award. As a result, the amount of expense related to awards to non-employees can fluctuate significantly during the period from the date of the grant through the final measurement date. The measured value related to the instruments is recognized over a period based on the facts and circumstances of each particular grant as defined in ASC 505. We recognize the compensation expense for all share-based compensation granted based on the grant date fair value estimated in accordance with ASC 718. We generally recognize the compensation expense on a straight-line basis over the employee’s requisite service period. We adopted ASU 2016-09, effective January 1, 2017, electing to account for forfeitures when they occur. Prior to that,
Research and Development Expenses	Research and Development Expenses Research and development, or R&D, expenses include internal R&D activities, services of external contract research organizations, or CROs, costs of their clinical research sites, manufacturing, laboratory supplies, scale-up and validation costs, and other activities. Internal R&D activity expenses include salaries, benefits, and non-cash share-based compensation expenses. Advance payments to be expensed in future research and development activities are capitalized, and were $0 at September 30, 2017 and $228,933 at December 31, 2016, all of which were included in other current assets on the accompanying consolidated balance sheets. CRO activity expenses include preclinical laboratory experiments and clinical trial studies. Other activity expenses include regulatory consulting and legal fees and costs. The activities undertaken by our regulatory consultants that were classified as R&D expenses include assisting, consulting with, and advising our in-house staff with respect to various U.S. Food and Drug Administration, or the FDA, submission processes, clinical trial processes, and scientific writing matters, including preparing protocols and FDA submissions. Legal activities include professional research and advice regarding R&D, patents and regulatory matters. These consulting and legal expenses were direct costs associated with preparing, reviewing, and undertaking work for our clinical trials and investigative drugs. We charge internal R&D activities and other activity expenses to operations as incurred. We make payments to CROs based on agreed-upon terms, which may include payments in advance of a study starting date. We expense nonrefundable advance payments for goods and services that will be used in future R&D activities when the activity has been performed or when the goods have been received rather than when the payment is made. We review and accrue CRO expenses and clinical trial study expenses based on services performed and rely on estimates of those costs applicable to the completion stage of a study as provided by CROs. Estimated accrued CRO costs are subject to revisions as such studies progress to completion. We charge revisions expense in the period in which the facts that give rise to the revision become known.
Segment Reporting	Segment Reporting We are managed and operated as one business, which is focused on creating and commercializing products targeted exclusively for women. Our business operations are managed by a single management team that reports to the President of our company. We do not operate separate lines of business with respect to any of our products and we do not prepare discrete financial information with respect to separate products. All product sales are derived from sales in the United States. Accordingly, we view our business as one reportable operating segment.

INVENTORY (Tables)

INVENTORY (Tables)	9 Months Ended
	Sep. 30, 2017
Inventory Disclosure [Abstract]
Schedule of inventory	Inventory consists of the following: September 30, 2017 December 31, 2016 Finished product $ 1,293,517 $ 1,062,285 Raw material — 14,036 TOTAL INVENTORY $ 1,293,517 $ 1,076,321

OTHER CURRENT ASSETS (Tables)

OTHER CURRENT ASSETS (Tables)	9 Months Ended
	Sep. 30, 2017
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
Schedule of other current assets	Other current assets consist of the following: September 30, 2017 December 31, 2016 Prepaid manufacturing costs $ 999,508 $ 991,809 Prepaid sales and marketing costs 535,936 — Prepaid insurance 953,792 628,039 Prepaid research and development costs — 100,035 Prepaid consulting — 128,898 Prepaid vendor deposits 5,000 44,311 Other prepaid costs 507,541 405,960 TOTAL OTHER CURRENT ASSETS $ 3,001,777 $ 2,299,052

FIXED ASSETS (Tables)

FIXED ASSETS (Tables)	9 Months Ended
	Sep. 30, 2017
Property, Plant and Equipment [Abstract]
Schedule of fixed assets	Fixed assets consist of the following: September 30, 2017 December 31, 2016 Accounting system $ 301,096 $ 301,096 Equipment 247,568 215,182 Computer hardware 80,211 80,211 Furniture and fixtures 116,542 113,079 Leasehold improvements 37,888 37,888 783,305 747,456 Accumulated depreciation (335,239 ) (230,617 ) TOTAL FIXED ASSETS $ 448,066 $ 516,839

INTANGIBLE ASSETS (Tables)

INTANGIBLE ASSETS (Tables)	9 Months Ended
	Sep. 30, 2017
Intangible Assets, Net (Excluding Goodwill) [Abstract]
Schedule of intangible assets	The following table sets forth the gross carrying amount and accumulated amortization of our intangible assets as of September 30, 2017 and December 31, 2016: September 30, 2017 Gross Carrying Amount Accumulated Amortization Net Amount Weighted- Average Remaining Amortization Amortizing intangible assets: OPERA ® $ 31,951 $ (7,988 ) $ 23,963 12 Development costs of corporate website 91,743 (91,743 ) — n/a Approved hormone therapy drug candidate patents 1,247,181 (153,216 ) 1,093,965 15.25 Hormone therapy drug candidate patents (pending) 1,474,061 — 1,474,061 n/a Non-amortizing intangible assets: Multiple trademarks 201,432 — 201,432 indefinite Total $ 3,046,368 $ (252,947 ) $ 2,793,421 December 31, 2016 Gross Carrying Amount Accumulated Amortization Net Amount Weighted- Average Remaining Amortization Amortizing intangible assets: OPERA ® $ 31,951 $ (6,490 ) $ 25,461 12.75 Development costs of corporate website 91,743 (91,743 ) — n/a Approved hormone therapy drug candidate patents 1,093,452 (102,393 ) 991,059 16 Hormone therapy drug candidate patents (pending) 1,203,987 — 1,203,987 n/a Non-amortizing intangible assets: Multiple trademarks 185,465 — 185,465 indefinite Total $ 2,606,598 $ (200,626 ) $ 2,405,972
Schedule of estimated amortization expense	Estimated amortization expense for the next five years for the patent cost currently being amortized is as follows: Year Ending Estimated 2017(3 months) $ 18,433 2018 $ 73,732 2019 $ 73,732 2020 $ 73,732 2021 $ 73,732 Thereafter $ 804,567

OTHER CURRENT LIABILITIES (Tabl

OTHER CURRENT LIABILITIES (Tables)	9 Months Ended
	Sep. 30, 2017
Other Liabilities Disclosure [Abstract]
Schedule of other current liabilities	Other current liabilities consist of the following: September 30, 2017 December 31, 2016 Accrued clinical trial costs $ 556,048 $ 1,281,080 Accrued payroll, bonuses and commission costs 2,662,359 3,531,440 Accrued compensated absences 952,587 665,561 Accrued legal and accounting expense 366,828 176,518 Accrued sales and marketing costs 69,041 665,773 Other accrued expenses 319,015 224,865 Allowance for wholesale distributor fees 145,563 76,510 Accrued royalties 93,870 26,507 Allowance for coupons and returns 1,218,249 794,816 Accrued rent 293,672 181,015 TOTAL OTHER CURRENT LIABILITIES $ 6,677,232 $ 7,624,085

NET LOSS PER SHARE (Tables)

NET LOSS PER SHARE (Tables)	9 Months Ended
	Sep. 30, 2017
Earnings Per Share [Abstract]
Schedule of potentially dilutive securities	The table below presents potentially dilutive securities that could affect our calculation of diluted net loss per share allocable to common stockholders for the periods presented. Nine Months Ended 2017 2016 Stock options 23,383,100 20,705,923 Warrants 3,115,905 12,060,571 26,499,005 32,766,494

STOCKHOLDERS' EQUITY (Tables)

STOCKHOLDERS' EQUITY (Tables)	9 Months Ended
	Sep. 30, 2017
Stockholders' Equity:
Schedule of assumptions used in the Black-Scholes Model of stock options	The assumptions used in the Black-Scholes Model for options granted during the nine months ended September 30, 2017 and 2016 are set forth in the table below. Nine Months Ended September 30, September 30, Risk-free interest rate 1.84-2.01% 1.13-1.70% Volatility 61.56-63.95% 70.26-71.22% Term (in years) 5.5-6.25 6.00-6.25 Dividend yield 0.00% 0.00%
Schedule of plan activity	A summary of activity under the 2009 and 2012 Plans and related information follows: Number of Shares Underlying Stock Options Weighted Average Exercise Price Weighted Aggregate Balance at December 31, 2016 21,767,854 $ 3.56 5.8 $ 60,495,730 Granted 2,184,500 $ 6.61 Exercised (102,546 ) $ 2.07 $ 452,287 Expired/Forfeited (466,708 ) $ 6.52 Balance at September 30, 2017 23,383,100 $ 3.79 5.4 $ 52,467,444 Vested and Exercisable at September 30, 2017 18,883,183 $ 3.15 4.6 $ 52,059,288 Unvested at September 30, 2017 4,499,917 $ 6.46 8.6 $ 408,156

COMMITMENTS AND CONTINGENCIES (

COMMITMENTS AND CONTINGENCIES (Tables)	9 Months Ended
	Sep. 30, 2017
Commitments and Contingencies Disclosure [Abstract]
Schedule of future minimum rental payments	As of September 30, 2017, future minimum rental payments on non-cancelable operating leases are as follows: Years Ending December 31, 2017 (3 months) $ 224,632 2018 951,194 2019 1,094,116 2020 1,113,069 2021 943,127 Total minimum lease payments $ 4,326,138

BASIS OF PRESENTATION AND REC29

BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS (Details Narrative)	9 Months Ended
	Sep. 30, 2017USD ($)
Basis Of Presentation And Recently Issued Accounting Pronouncements Details Narrative
Amount of adjustment for provisions related to forfeiture rates	$ 31,000

SUMMARY OF SIGNIFICANT ACCOUN30

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative)	9 Months Ended
	Sep. 30, 2017USD ($)Segment	Dec. 31, 2016USD ($)
Number of reportable segments | Segment	1
Related to Research and Development Activities [Member]
Advance payments | $	$ 0	$ 228,933

INVENTORY (Details)

INVENTORY (Details) - USD ($)	Sep. 30, 2017	Dec. 31, 2016
Inventory
Finished product	$ 1,293,517	$ 1,062,285
Raw material		14,036
TOTAL INVENTORY	$ 1,293,517	$ 1,076,321

OTHER CURRENT ASSETS (Details)

OTHER CURRENT ASSETS (Details) - USD ($)	Sep. 30, 2017	Dec. 31, 2016
Other Current Assets
Prepaid manufacturing costs	$ 999,508	$ 991,809
Prepaid sales and marketing costs	535,936
Prepaid insurance	953,792	628,039
Prepaid research and development costs		100,035
Prepaid consulting		128,898
Prepaid vendor deposits	5,000	44,311
Other prepaid costs	507,541	405,960
TOTAL OTHER CURRENT ASSETS	$ 3,001,777	$ 2,299,052

FIXED ASSETS (Details)

FIXED ASSETS (Details) - USD ($)	Sep. 30, 2017	Dec. 31, 2016
Property, Plant and Equipment [Line Items]
Fixed assets, gross	$ 783,305	$ 747,456
Accumulated depreciation	(335,239)	(230,617)
TOTAL FIXED ASSETS	448,066	516,839
Accounting system [Member]
Property, Plant and Equipment [Line Items]
Fixed assets, gross	301,096	301,096
Equipment [Member]
Property, Plant and Equipment [Line Items]
Fixed assets, gross	247,568	215,182
Computer hardware [Member]
Property, Plant and Equipment [Line Items]
Fixed assets, gross	80,211	80,211
Furniture and fixtures [Member]
Property, Plant and Equipment [Line Items]
Fixed assets, gross	116,542	113,079
Leasehold improvements [Member]
Property, Plant and Equipment [Line Items]
Fixed assets, gross	$ 37,888	$ 37,888

FIXED ASSETS (Details Narrative

FIXED ASSETS (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016
Property, Plant and Equipment [Abstract]
Depreciation expense	$ 35,622	$ 26,543	$ 104,622	$ 45,759

INTANGIBLE ASSETS (Details)

INTANGIBLE ASSETS (Details) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2017	Dec. 31, 2016
Finite-Lived Intangible Assets
Accumulated Amortization	$ (252,947)	$ (200,626)
Indefinite-Lived Intangible Assets
Gross Carrying Amount	3,046,368	2,606,598
Net Amount	2,793,421	2,405,972
Hormone Therapy Drug Candidate Patents - (Pending) [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	1,474,061	1,203,987
Net Amount	1,474,061	1,203,987
Multiple Trademarks [Member]
Indefinite-Lived Intangible Assets
Gross Carrying Amount	201,432	185,465
Net Amount	201,432	185,465
Opera Software Patent [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	31,951	31,951
Accumulated Amortization	(7,988)	(6,490)
Net Amount	$ 23,963	$ 25,461
Weighted average remaining amortization period	12 years	12 years 9 months
Development Costs Of Corporate Website [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	$ 91,743	$ 91,743
Accumulated Amortization	(91,743)	(91,743)
Approved Hormone Therapy Drug Candidate Patents [Member]
Finite-Lived Intangible Assets
Gross Carrying Amount	1,247,181	1,093,452
Accumulated Amortization	(153,216)	(102,393)
Net Amount	$ 1,093,965	$ 991,059
Weighted average remaining amortization period	15 years 3 months	16 years

INTANGIBLE ASSETS (Details 1)

INTANGIBLE ASSETS (Details 1)	Dec. 31, 2016USD ($)
Estimated amortization expense for the year:
2017(3 months)	$ 18,433
2,018	73,732
2,019	73,732
2,020	73,732
2,021	73,732
Thereafter	$ 804,567

INTANGIBLE ASSETS (Details Narr

INTANGIBLE ASSETS (Details Narrative)	3 Months Ended		9 Months Ended
	Sep. 30, 2017USD ($)Number	Sep. 30, 2016USD ($)	Sep. 30, 2017USD ($)Number	Sep. 30, 2016USD ($)
Finite-Lived Intangible Assets [Line Items]
Amortization expense | $	$ 18,433	$ 13,917	$ 52,321	$ 38,560
Number of issued patents	17		17
Approved Hormone Therapy Drug Candidate Patents [Member]
Finite-Lived Intangible Assets [Line Items]
Useful Life			20 years
Utility Patent Progesterone and Estradiol Products [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	13		13
Utility Patent TX-004HR [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	2		2
Utility Patent Pipeline Transdermal Patch Technology [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	1		1
Opera Software Patent [Member]
Finite-Lived Intangible Assets [Line Items]
Number of issued patents	1		1

OTHER CURRENT LIABILITIES (Deta

OTHER CURRENT LIABILITIES (Details) - USD ($)	Sep. 30, 2017	Dec. 31, 2016
Other Liabilities Disclosure [Abstract]
Accrued clinical trial costs	$ 556,048	$ 1,281,080
Accrued payroll, bonuses and commission costs	2,662,359	3,531,440
Accrued compensated absences	952,587	665,561
Accrued legal and accounting expense	366,828	176,518
Accrued sales and marketing costs	69,041	665,773
Other accrued expenses	319,015	224,865
Allowance for wholesale distributor fees	145,563	76,510
Accrued royalties	93,870	26,507
Allowance for coupons and returns	1,218,249	794,816
Accrued rent	293,672	181,015
TOTAL OTHER CURRENT LIABILITIES	$ 6,677,232	$ 7,624,085

NET LOSS PER SHARE (Details)

NET LOSS PER SHARE (Details) - shares	9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive shares excluded from earnings per share calculation	26,499,005	32,766,494
Warrants [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive shares excluded from earnings per share calculation	3,115,905	12,060,571
Stock Options [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive shares excluded from earnings per share calculation	23,383,100	20,705,923

NET LOSS PER SHARE (Details Nar

NET LOSS PER SHARE (Details Narrative) - $ / shares	Sep. 30, 2017	Dec. 31, 2016
Earnings Per Share [Abstract]
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001

STOCKHOLDERS' EQUITY (Details)

STOCKHOLDERS' EQUITY (Details) - Stock Options [Member]	9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Risk-free interest rate - minimum	1.84%	1.13%
Risk-free interest rate - maximum	2.01%	1.70%
Volatility - minimum	61.56%	70.26%
Volatility - maximum	63.95%	71.22%
Dividend yield	0.00%	0.00%
Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Term	5 years 6 months	6 years
Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Term	6 years 3 months	6 years 3 months

STOCKHOLDERS' EQUITY (Details 1

STOCKHOLDERS' EQUITY (Details 1) - USD ($)	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016	Dec. 31, 2016
Options, Outstanding
Options Exercised	(2,500)	(10,000)	(102,546)	(427,168)
Stock Options [Member]
Options, Outstanding
Options outstanding, beginning			21,767,854
Options Granted			2,184,500
Options Exercised			(102,546)
Options Expired/Forfeited			(466,708)
Options outstanding, ending	23,383,100		23,383,100		21,767,854
Vested and Exercisable	18,883,183		18,883,183
Unvested	4,499,917		4,499,917
Options, Weighted Average Exercise Price
Options outstanding, beginning			$ 3.56
Granted			6.61
Exercised			2.07
Expired/Forfeited			6.52
Options outstanding, ending	$ 3.79		3.79		$ 3.56
Vested and Exercisable	3.15		3.15
Unvested	$ 6.46		$ 6.46
Options, Weighted Average Remaining Contractual Life
Options outstanding			5 years 4 months 24 days		5 years 9 months 18 days
Vested and Exercisable			4 years 7 months 6 days
Unvested			8 years 7 months 6 days
Options outstanding, Aggregate Intrinsic Value
Options outstanding, beginning			$ 60,495,730
Options exercised			452,287
Options outstanding, ending	$ 52,467,444		52,467,444		$ 60,495,730
Vested and Exercisable	52,059,288		52,059,288
Unvested	$ 408,156		$ 408,156

STOCKHOLDERS' EQUITY (Details N

STOCKHOLDERS' EQUITY (Details Narrative) - USD ($)	Sep. 28, 2017	Sep. 25, 2017	Jan. 12, 2016	Jan. 06, 2016	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016	Dec. 31, 2016
Preferred stock, par value (in dollars per share)					$ 0.001		$ 0.001		$ 0.001
Preferred stock, shares authorized					10,000,000		10,000,000		10,000,000
Preferred stock, shares issued					0		0		0
Preferred stock, shares outstanding					0		0		0
Common stock, shares authorized					350,000,000		350,000,000		350,000,000
Common stock, shares issued					216,429,642		216,429,642		196,688,222
Common stock, shares outstanding					216,429,642		216,429,642		196,688,222
Value of common stock issued during period for stock options exercised					$ 255	$ 1,018	$ 212,615	$ 979,060
Number of common stock issued during period for stock options exercised (in shares)					2,500	10,000	102,546	427,168
Number of stock options exercised (in shares)						127,109		544,277
Number of stock options exercised in cashless exercise (in shares)						117,109		117,109
Number of common stock issued during period for stock options exercised in cashless exercise (in shares)						78,017		78,017
Underwriting Agreement - J.P. Morgan Securities LLC [Member]
Number of shares issued during the period	12,400,000	12,400,000
Share price (in dollars per share)		$ 5.55
Common stock issued during the period		$ 68,573,000
Underwriting Agreement - Goldman and Cowen [Member]
Number of shares issued during the period			17,424,242	15,151,515
Share price (in dollars per share)				$ 8.25
Common stock issued during the period				$ 134,864,000
Additional common stock issued under offering				2,272,727
Number of days of the option to purchase shares				30 days

STOCKHOLDERS' EQUITY (Details44

STOCKHOLDERS' EQUITY (Details Narrative 1) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016
Warrants:
Warrants outstanding	$ 3,115,905		$ 3,115,905
Weighted-average contractual remaining life			2 years 29 days
Weighted average exercise price of warrants (in dollars per share)	$ 2.58		$ 2.58
Share based compensation expense			$ 5,037,783	$ 13,385,215
Outside Consultant Warrants [Member]
Warrants:
Exercise price of warrants (in dollars per share)	$ 6.83		$ 6.83
Weighted average exercise price of warrants (in dollars per share)		$ 7.90		$ 7.90
Warrants granted (in shares)			125,000	245,000
Grant date fair value (in dollars per share)			$ 3.67	$ 4.78
Expiration date of warrants			Mar. 15, 2022	Jan. 21, 2021
Vesting period of warrants			12 months	12 months
Expected term			5 years	5 years
Volatility rate			63.24%
Risk free rate			1.47%
Dividend yield			0.00%	0.00%
Outside Consultant Warrants [Member] | Tranche One [Member]
Warrants:
Warrants granted (in shares)			75,000
Expiration date of warrants			Apr. 21, 2021
Vesting date of warrants			Apr. 21, 2016
Outside Consultant Warrants [Member] | Tranche Two [Member]
Warrants:
Warrants granted (in shares)			50,000
Expiration date of warrants			Apr. 21, 2021
Vesting period of warrants			24 months
Outside Consultant Warrants [Member] | Tranche Three [Member]
Warrants:
Warrants granted (in shares)			120,000
Expiration date of warrants			Jan. 21, 2021
Vesting period of warrants			12 months
Warrants [Member]
Warrants:
Share based compensation expense	$ 101,376	$ 137,161	$ 217,150	$ 820,751
Unamortized costs	$ 279,000		$ 279,000
Minimum [Member]
Warrants:
Exercise price of warrants (in dollars per share)	$ 0.24		$ 0.24
Minimum [Member] | Outside Consultant Warrants [Member]
Warrants:
Volatility rate				74.10%
Risk free rate				1.04%
Maximum [Member]
Warrants:
Exercise price of warrants (in dollars per share)	$ 8.20		$ 8.20
Maximum [Member] | Outside Consultant Warrants [Member]
Warrants:
Volatility rate				74.15%
Risk free rate				1.28%

STOCKHOLDERS' EQUITY (Details45

STOCKHOLDERS' EQUITY (Details Narrative 2) - USD ($)	Jun. 30, 2013	May 11, 2013	May 31, 2013	May 31, 2012	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016
Non-cash compensation expense							$ 5,037,783	$ 13,385,215
SCI - Warrants [Member]
Exercise price of warrants (in dollars per share)			$ 2.01
Warrants granted to purchase common stock (shares)			850,000
Forfeited warrants granted to purchase common stock (shares)			833,000
SCI - Warrants [Member] | Tranche One [Member]
Fair value of grant	$ 405,066
Non-cash compensation expense	405,066
Vesting date of warrants		Jun. 30, 2013
Expected term		5 years
Volatility rate		45.89%
Risk free rate		1.12%
Dividend yield		0.00%
Vested warrants granted to purchase common stock (shares)		283,333
SCI - Warrants [Member] | Tranche Two [Member]
Fair value of grant	$ 462,196
Non-cash compensation expense							0	77,026
Expected term	5 years
Volatility rate	45.84%
Risk free rate	1.41%
Dividend yield	0.00%
Vested warrants granted to purchase common stock (shares)	283,333
SCI - Warrants [Member] | Tranche Three [Member]
Description of shares to be vested	283,334 shares will vest upon the receipt by us of any final FDA approval of a drug candidate that SCI helped us design. It is anticipated that this event will occur in the near future.
Warrants - Unaffiliated Entity [Member]
Exercise price of warrants (in dollars per share)				$ 2.57
Fair value of grant				$ 1,532,228
Warrants granted to purchase common stock (shares)				1,300,000
Non-cash compensation expense					$ 0	$ 64,449	$ 128,898	$ 193,347
Expected term				5 years
Volatility rate				44.71%
Risk free rate				0.74%
Dividend yield				0.00%

STOCKHOLDERS' EQUITY (Details46

STOCKHOLDERS' EQUITY (Details Narrative 3) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016	Dec. 31, 2016
Share-based compensation expense	$ 1,885,050	$ 3,982,759	$ 4,691,735	$ 12,294,089
Total unrecognized estimated compensation expense	$ 12,419,000		$ 12,419,000
Recognized weighted-average period			2 years 2 months 12 days
Weighted average grant date fair value (per share)			$ 3.82	$ 4.70
Stock Options [Member]
Options outstanding, ending	23,383,100		23,383,100		21,767,854
Stock Options [Member] | Minimum [Member]
Option exercise prices (in dollars per shares)	$ 0.10		$ 0.10
Stock Options [Member] | Maximum [Member]
Option exercise prices (in dollars per shares)	$ 8.92		$ 8.92
2009 Long Term Incentive Compensation Plan [Member]
Number of shares authorized for issuance	25,000,000		25,000,000
Options outstanding, ending	18,592,959		18,592,959
Number of shares available for issuance	2,156,003		2,156,003
Vesting period			4 years
Expiration period			10 years
2012 Stock Incentive Plan [Member]
Number of shares authorized for issuance	10,000,000		10,000,000
Options outstanding, ending	4,790,141		4,790,141
Number of shares available for issuance	5,128,333		5,128,333
Vesting period			4 years
Expiration period			10 years
Warrants [Member] | Individuals [Member]
Shares issued for exercise of warrants, net			$ 3,798,999	$ 1,373,000
Shares issued for exercise of warrants, net (in shares)			2,476,666	722,744
Warrants - Cashless Exercise [Member]
Shares issued for exercise of warrants, net (in shares)			4,762,208
Warrants exercised			6,590,000

RELATED PARTIES (Details Narrat

RELATED PARTIES (Details Narrative) - Catalent Inc.[Member] - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016	Dec. 31, 2016
Related Party Transaction [Line Items]
Manufacturing activities billed from related party	$ 186,000	$ 828,000	$ 2,646,000	$ 2,907,000
Payable - related party	$ 26,000		$ 26,000		$ 57,000

BUSINESS CONCENTRATIONS (Detail

BUSINESS CONCENTRATIONS (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016
Concentration Risk [Line Items]
Revenues	$ 4,417,598	$ 5,535,685	$ 12,653,495	$ 14,869,023
Supplier Concentration Risk [Member]
Concentration Risk [Line Items]
Concentration Risk	100.00%	97.00%	100.00%	97.00%
Customer Concentration Risk [Member] | Sales Revenue [Member] | Pharmacy Innovations PA [Member]
Concentration Risk [Line Items]
Revenues			$ 2,715,000	$ 2,113,000
Customer Concentration Risk [Member] | Sales Revenue [Member] | AmerisourceBergen [Member]
Concentration Risk [Line Items]
Revenues			1,716,000
Customer Concentration Risk [Member] | Sales Revenue [Member] | Cardinal Health [Member]
Concentration Risk [Line Items]
Revenues			1,764,000
Customer Concentration Risk [Member] | Sales Revenue [Member] | McKesson Corporation [Member]
Concentration Risk [Line Items]
Revenues			$ 1,458,000
Customer Concentration Risk [Member] | Sales Revenue [Member] | Woodstock Pharmaceutical and Compounding [Member]
Concentration Risk [Line Items]
Revenues				2,247,000
Customer Concentration Risk [Member] | Sales Revenue [Member] | Medical Center Pharmacy [Member]
Concentration Risk [Line Items]
Revenues				2,683,000
Customer Concentration Risk [Member] | Sales Revenue [Member] | Due West Pharmacy [Member]
Concentration Risk [Line Items]
Revenues				$ 1,890,000
Customer Concentration Risk [Member] | Sales Revenue [Member] | Four Customers [Member]
Concentration Risk [Line Items]
Concentration Risk			60.00%	60.00%
Customer Concentration Risk [Member] | Sales Revenue [Member] | Four Customers [Member] | Minimum [Member]
Concentration Risk [Line Items]
Concentration Risk			10.00%	10.00%

COMMITMENTS AND CONTINGENCIES49

COMMITMENTS AND CONTINGENCIES (Details)	Sep. 30, 2017USD ($)
Future minimum rental payments, year ending December 31,
2017 (3 months)	$ 224,632
2,018	951,194
2,019	1,094,116
2,020	1,113,069
2,021	943,127
Total minimum lease payments	$ 4,326,138

COMMITMENTS AND CONTINGENCIES50

COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)	May 01, 2016	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016
Commitments and Contingencies Disclosure [Abstract]
Non-cancelable operating lease term				63 months
Rental expense		$ 257,000	$ 182,000	$ 772,000	$ 482,000
Expiration date	Oct. 31, 2021