October 26, 2011
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, D.C. 20549
Attn: Laura Crotty
| Re: | Premier Biomedical, Inc. |
Amendment No. 3 to Registration Statement on Form S-1
File No. 333-174876
Dear Ms. Crotty:
On behalf of Premier Biomedical, Inc. (the “Company’), we herein provide the following responses to the Commission Staff comment letter dated October 13, 2011, regarding the above-listed Registration Statement on Form S-1 for the Company. We have summarized the Staff’s comments in bold and italics followed by the Company’s response.
General
1. Please revise your financial statements to present audited financial statements for the period ended December 31, 2010, and unaudited financial statements for the period ended June 30, 2011. Rule 3-02 of Regulation S-X requires the presentation of statements of income and cash flows for the interim period between the latest audited balance sheet and the date of the most recent interim balance sheet being filed, and for the corresponding period of the preceding fiscal year. However, presenting balance sheets for the interim period between the latest audited balance sheet and the date of the most recent interim balance sheet being filed is not required.
The financial statements have been revised as requested.
2. Please ensure that you label all financial statements and notes that you revised as restated. For example, the audited balance sheet for the audited period ended December 31, 2010 on page F-19 should be labeled as restated.
Respectfully, the financial statements had been labeled as restated at the top of the statement as both periods presented had been restated. The Company has carried it to the top of each column now as well to avoid confusion.
Laura Crotty
U.S. Securities and Exchange Commission
Division of Corporation Finance
October 26, 2011
Page 2
3. We acknowledge your revised disclosures in response to prior comments 13, 14, 15 and 16. Throughout your document you state that you established the fair value of certain warrants based on an independent valuation. This disclosure appears to infer that the values allocated to warrants were taken directly from a report provided by a third party appraisal firm or that management determined the value of the warrants based on data in a third-party valuation report. Please clarify for us. If you continue to include this disclosure, you must name the appraisal firm and provide their consent in any ’33 Act filing that includes this reference. On the other hand, if you determined the valuation of the warrants and in doing so considered or relied in part upon a report of a third party appraisal firm, and the disclosure so states, or the disclosure attributes the valuation to the registrant and not a third party appraisal firm, then there would be no requirement to comply with Rule 436 with respect to the valuation figures. Please refer to the answer to question 233.02 of Compliance and Disclosure Interpretations related to Securities Act Rules that can be found on our website.
The Company determined the fair value of the warrants based upon information it received from a third party appraisal firm. Management accounted for the warrants and in doing so considered or relied in part upon a report of a third party expert. As such, it will remove the reference to a 3rd party valuation within the disclosures to clearly attribute the valuation figures to the registrant, rather than the third party expert. As a result, there won’t be a requirement to comply with Rule 436 with respect to the valuations as the fair values are attributed to the registrant.
License Agreements, page 21
4. We note the information provided in your supplemental response letter in response to our prior comment 6 regarding the definition of PCT. Please add this information to your registration statement, where applicable.
The following disclosure was added in the Description of Business section, the first place reference to PCT is made:
PCT stands for the Patent Cooperation Treaty (PCT), which is an international patent law treaty which was concluded in 1970. It provides a unified procedure for filing patent applications to protect inventions in each of its contracting countries. A patent application filed under the PCT is called an international application, or PCT application.
Feldetrex, page 29
5. We note the disclosure added to pages 6 and 29 in response to our prior comments 2 and 4. Please revise your disclosure in the “Regulation” section starting on page 26 to separately discuss the specific regulatory pathway to be followed for each of the indications for which you expect to market Feldetrex. Also, please consider and address in the disclosure the fact that, despite the fact that Feldetrex contains an approved drug combined with vitamins, the company intends to market the product for indications for which efficacy has not been previously demonstrated in clinical trials submitted to the FDA and for which approval has not been obtained. In that regard you should also consider the appropriateness of the disclosure added to page 6 under the risk factor “The FDA might not approve our product candidates for marketing and sale.” If you still believe that this disclosure is appropriate in light of the revisions made in response to this comment, you should provide a substantive legal analysis supporting your conclusion that FDA approval of Feldetrex can be obtained using an ANDA despite the fact that Feldetrex will be used for currently unapproved indications of Naltrexone.
Management of the Company believes that it will most likely license a product such as Feldetrex to a larger pharmaceutical company, and thus any regulatory pathway that must be navigated will be done by them. The disclosure in the referenced locations, as well as several other locations in the prospectus, has been revised accordingly.
Laura Crotty
U.S. Securities and Exchange Commission
Division of Corporation Finance
October 26, 2011
Page 3
Potential for Feldetrex, page 32
6. Please define “endogenous enkephalins” where first used on page 32.
The company’s first reference to, “endogenous enkephalins” was on page 29, rather than 32. The Company has revised its disclosure on page 29 to define, “endogenous enkephalins” as follows:
Feldetrex™ utilizes a low dosage of Naltrexone which has been shown in multiple medical articles, in the medical literature, to increase endogenous enkephalins (endogenous enkephalins are pain-relieving pentapeptides produced in the body, located in the pituitary gland, brain, and GI tract. Axon terminals that release enkephalins are concentrated in the posterior horn of the gray matter of the spinal cord, in the central part of the thalamus, and in the amygdala of the limbic system of the cerebrum. Endogenous Enkephalins function as neurotransmitters that inhibit neurotransmitters in the pathway for pain perception, thereby reducing the emotional as well as the physical impact of pain).
Financial Statements as at December 31, 2010, audited
Notes to Financial Statements
Note 7 - Stockholders’ Equity, page F-29
7. We acknowledge your revised disclosures in response to prior comments 15 and 16. Please clarify for us and revise your disclosure to state, if true, that you allocated the proceeds received in the financing transactions on a relative fair value basis.
The Company did in fact allocate the proceeds received in the financing transactions on a relative fair value basis, and will revise its disclosures throughout to state that the proceeds received were allocated between the common stock and warrants on a relative fair value basis.
8. Please consider disclosing the narrative disclosure made in response to prior comment 15 in tabular form. Similar disclosure should be made in an appropriate section of your MD&A and should be updated for any new equity issuances up until the time of effectiveness of your registration statement. Please also disclose the expected term of each of the common stock and warrant issuances.
The Company has added tables as supplemental information to Note 7 and the MD&A as requested.
Laura Crotty
U.S. Securities and Exchange Commission
Division of Corporation Finance
October 26, 2011
Page 4
9. Please provide us with an analysis that supports the fair value of each common stock and warrant issuance.
Please see the two valuation reports related to the financing transactions dated June 21, 2010 and February 28, 2011.
Financial Statements at June 30, 2011, Unaudited
10. Please update the unaudited financial statements and related disclosures based on the comments related to the audited financial statements as at December 31, 2010 as applicable.
The Company acknowledges the Commission’s request and has carried all applicable revisions to the unaudited period, as well as the audited period presented.
Company Statements
| · | The Company is responsible for the adequacy and accuracy of the disclosure in the filing; |
| · | Staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and |
| · | The Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. |
The letter attached hereto indicates the Company’s agreement and affirmation of the above “Company Statements.”
Please do not hesitate to contact me if you have any questions. Thank you for your time and attention to this matter.
Sincerely,
/s/ Brian A. Lebrecht, Esq.
Brian A. Lebrecht, Esq.
October 26, 2011
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, D.C. 20549
Attn: Laura Crotty
| Re: | Premier Biomedical, Inc. |
Amendment No. 2 to Registration Statement on Form S-1
File No. 333-174876
Dear Ms. Crotty:
Premier Biomedical, Inc. (the “Company”) hereby affirms and agrees with the following statements related to the comment response for the above-mentioned filing to be filed with the Commission on October 26, 2011:
Company’s Statements
| · | The Company is responsible for the adequacy and accuracy of the disclosure in the filing; |
| · | Staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and |
| · | The Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. |
Please do not hesitate to contact me if you have any questions. Thank you for your time and attention to this matter.
Sincerely,
/s/ William A. Hartman
William A. Hartman
Chief Executive Officer