8-K 1 v092249_8k.htm Unassociated Document
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
 
November 1, 2007
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:

o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o 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 November 1, 2007, Discovery Laboratories, Inc. (the “Company”) issued a press release announcing that it has submitted its formal response to the U.S. Food and Drug Administration’s (FDA) April 2006 Approvable Letter for Surfaxin® for the prevention of Respiratory Distress Syndrome (RDS) in premature infants.

The FDA’s guidelines provide that within 14 days of receipt of the formal submission, if the FDA has accepted the submission as a complete response, it should provide a review classification that determines the targeted review timeframe. Discovery Labs anticipates that the FDA will designate the formal response as a Class 2 submission, thereby allowing for a six-month review period, with a target PDUFA date in the second quarter of 2008. The full text of the press release, dated November 1, 2007, 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 November 1, 2007
 
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
 
Robert J. Capetola, Ph.D.
  President and Chief Executive Officer
   
Date: November 2, 2007  
 
 
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