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Sarepta Therapeutics, Inc. Message Board

  • simp08801 simp08801 Jun 19, 2013 8:21 PM Flag

    transcript of today's presentation

    read the sentence relating to the tentative FDA meeting by end of July

    am I crazy, or does that statement seem to suggest that at the meeting, the CEO expects the FDA to give him its "decision" on whether or not it will accept an AA app for filing

    my guess is that if he intended to say that, there may not be a 30ish day minute process before the meeting result is announced by Srpt

    remember, the second meeting is NOT an end of phase 2 meeting and is not bound by the customary FDA process relating to such phase 2 meetings

    you could literally know the outcome of the meeting within a day of the meeting

    JMO, based on the exact words the CEO used today

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    • I was just reading a similar understanding at the Rare Disease Report (RDR) article dated yesterday (Wed June 13, 2013). The article's title is Eteplirsen Treatment in Duchenne Muscular Dystrophy – Week 8. It has the remark

      "As RDR reported last month, Sarepta has submitted two papers to the FDA (one on surrogate markers and one on clinical outcomes) and while Mr Garabedian downplayed his concerns with what the FDA will say about those papers, we at Rare Disease Report are very interesting (sic) in hearing what the FDA will decide (likely at their next meeting tentatively scheduled for the end of July)."

      Looks like we'll be getting news on AA by the end of July.

      Sentiment: Strong Buy

    • here are the words:

      "we expect that at that meeting, they'll have reviewed the two documents we submitted one on dystrophin, one on clinical outcomes to be able to make their recommendation or guidance for us on whether or not a accelerated approval NDA that we would submit will be accepted for filing"

      "at that meeting"?

      as in right then and there?

      if so, I believe that goes on the tape ASAP

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