SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
___________________________
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
May 29, 2008
Date of Report (Date of earliest event reported)
Discovery Laboratories, Inc.
(Exact name of registrant as specified in its charter)
Delaware | 000-26422 | 94-3171943 |
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification Number) |
2600 Kelly Road, Suite 100
Warrington, Pennsylvania 18976
(Address of principal executive offices)
(215) 488-9300
(Registrant's telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01. | Other Events. |
On May 29, 2008, Discovery Laboratories, Inc. (the “Company”) issued a press release announcing that it has received from the U.S. Food and Drug Administration (FDA) written notification that a meeting between the FDA and the Company has been scheduled to occur by teleconference on June 18, 2008. On May 14, 2008, the Company submitted a formal request to the FDA to schedule such a meeting. The formal request was accompanied by an information package containing the Company’s proposals to address a limited number of the remaining items identified in the Approvable Letter that the Company received on May 1, 2008 for Surfaxin® (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. If the June 18 meeting positively confirms the Company’s approach to filing its formal response to the Approvable Letter, the Company plans to submit a formal response to the Approvable Letter in June 2008. The Company believes that the response may potentially be designated by the FDA as a Class 1 resubmission with a review target of 60 days. The overall timeline to gaining approval for Surfaxin may vary depending on the outcome of the meeting and other related factors. The press release, dated May 29, 2008, is filed as Exhibit 99.1 to this report and is incorporated herein by reference.
Item 9.01. | Financial Statements and Exhibits. |
(d) | Exhibits |
99.1 | Press release dated May 29, 2008 |
Cautionary Note Regarding Forward-looking Statements:
To the extent that statements in this Current Report on Form 8-K are not strictly historical, including statements as to business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company’s product development or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this Current Report are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Such risks and others are further described in the Company's filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Discovery Laboratories, Inc. | ||
| | |
By: | /s/ Robert J. Capetola | |
Name: | Robert J. Capetola, Ph.D. | |
Title: | President and Chief Executive Officer |
Date: May 29, 2008
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