Discovery Labs (DSCO) Receives Clarification from FDA on Limited Items in SURFAXIN Approvable Letter
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Discovery Laboratories, Inc. (Nasdaq: DSCO), meeting with the U.S. FDA, today announced that it has received clarification on its proposals in regards to potentially gaining U.S. marketing approval of SURFAXIN(r) and believes that it could submit its formal response to the Approvable Letter in September 2008. Discovery Labs also believes that this response may be designated by the FDA as a Class 1 resubmission with a target review period of 60 days.
Discovery Laboratories, Inc., together with its subsidiaries, operates as a biotechnology company that develops proprietary surfactant technology as Surfactant Replacement Therapies (SRT) for respiratory disorders and diseases.
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