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| DSCO > SEC Filings for DSCO > Form 8-K on 10-Nov-2008 | All Recent SEC Filings |
10-Nov-2008
Results of Operations and Financial Condition, Other Events, Fina
On November 4, 2008, Discovery Laboratories, Inc. (the "Company") issued a press release announcing financial results for the quarter ended September 30, 2008. The press release is attached as Exhibit 99.1 hereto.
In accordance with General Instruction B.2 of Form 8-K, the information in Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in any such filings.
On November 7, 2008, the Company issued a press release announcing that the U.S. Food and Drug Administration (FDA) has accepted as a Complete Response the Company's formal response to the Approvable Letter dated May 1, 2008, that the FDA issued to the Company in connection with its review of the New Drug Application (NDA) for SurfaxinŽ (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The FDA has established April 17, 2009 as its target action date to complete its review of the Surfaxin NDA. The press release, dated November 7, 2008, is filed as Exhibit 99.2 to this report and is incorporated herein by reference.
On November 10, 2008, the Company held a conference call to discuss the regulatory status of Surfaxin and the Company's financial results for the third quarter ended September 30, 2008. On the call, the Company provided an estimate of the anticipated net cash outflows for the fourth quarter of 2008 of approximately $8.0 million and for the first quarter of 2009 of approximately $7.0 million. Until the FDA has completed its review of the Surfaxin NDA, the Company plans to restrain program development activities to conserve cash resources and to take other actions, including potentially drawing down on its Committed Equity Financing Facilities (CEFFs), aimed at maintaining available cash at a level necessary to fund approximately one year of its projected cash requirements.
(d) Exhibits
99.1 Press release dated November 4, 2008
99.2 Press release dated November 7, 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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