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Sarepta Therapeutics, Inc. Message Board

  • bavaris7 bavaris7 Apr 15, 2013 4:40 PM Flag

    fda not so confident in the drug

    the data doesn't support it enough to just give a green light. something important must be missing in the minds of fda. this could be a drag going forward. the company's press release tries to sound positive about this. I've seen these things before...been in many biotechs in the past...and I have good records at it.

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    • not so...................................asking for more information rather than informing sarepta that they would need to complete a PH 3 trial before they would consider it ..........................they said they would consider now with more information..........................no one expected a blanket approval now...................only that they would inform them to apply for AA