8-K 1 v148867_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


May 11, 2009
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 May 11, 2009, Discovery Laboratories, Inc. (the “Company”) issued a press release announcing that it has received written notification from the U.S. Food and Drug Administration (FDA) that an end-of-review meeting has been scheduled for June 2, 2009 at the FDA offices in Rockville, Maryland.  The purpose of this meeting is to determine the resolution of the remaining primary issue necessary for Discovery Labs to gain U.S. marketing approval of Surfaxin® (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants.  Following the meeting and receipt of formal written minutes from the FDA, Discovery Labs intends to provide an update regarding the outcome and anticipated timeline to potential approval of Surfaxin. The press release is attached as Exhibit 99.1 hereto.
 
Item 9.01.
Financial Statements and Exhibits.
 
(d)
Exhibits

 
99.1
Press release dated May 11, 2009
 
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 12, 2009
 
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