Introgen Therapeutics (INGN) BLA Not Sufficiently Complete Says FDA
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Introgen Therapeutics, Inc. (NASDAQ: INGN) announced that the FDA notified the Company that its Biologics License Application (BLA) for ADVEXIN for the treatment of recurrent, refractory squamous cell carcinoma of the head and neck, submitted on June 30, 2008, was not sufficiently complete and would not be filed at this time. The Company intends to appeal this refuse to file decision and is reviewing the various options available to it.
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