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Sarepta Therapeutics, Inc. Message Board

  • simp08801 simp08801 Mar 20, 2013 6:00 PM Flag

    what we do not know, and what we do know

    we have absolutely no clue what will actually transpire at the FDA meeting, in terms of whether the FDA will signal that Srpt should file an AA app

    and we will not know until Srpt publicly states what happened

    but we do know something

    we now know, with reasonable certaintiy, the time period during which we will find out

    and that time period is:

    Monday, March 25 to and including April 22

    while it is probably most likely that we will not hear from Srpt until after the FDA delivers the minutes, we need to remember that "30 days" is a typical time for delivery of the minutes, but it can be sooner

    also, if the FDA sends a clear and unequivocal message to Srpt during the meeting, Srpt may have a disclosure issue that would mandate it publicly disclose that FDA signal in advance of the receipt of the FDA minutes

    thus, the time frame set forth above, which I think takes all of these possiblities into consideration

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    • simp - you are forgetting that there are two meetings - they said there was a separate meeting in April to go over manufacturing issues. My guess is that the FDA will not give them "guidance" on an AA until they have a better understanding of whether they can get the manufacturing up to scale in order to support commercialization in 2014.

    • The meeting was this week I believe but what day? I was hoping to see some real volume. Worst case they dont get AA, and I add more at $25 its a win/win!

 
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