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Sarepta Therapeutics, Inc. Message Board

  • encore7 encore7 Mar 7, 2013 7:59 PM Flag

    Possible news on March 11

    With DMD Hero (represented by Jenn) and the Jett Foundation invited to meet the commissioner of the FDA on March 11, I think there's a chance for a big announcement on that day - namely an announcement of breakthrough drug status for eteplirsen. Others on the board have also mentioned this possibility. It's a long shot, I know, but we'll see.

    Sentiment: Strong Buy

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    • There's been a question of whether the FDA has any data yet, and Chris deferred, saying the status of communication with FDA was not going to be addressed.
      HOWEVER, he noted (minute 101 of webcst) that the whole study design regarding, for instance, kidney function/effects/testing was done with FDA input . If the FDA was involved like that even in this study's design, fairly open communication along the way is not hard to imagine.
      Dr. Woodcock's talk a few weeks ago: FDA may INVITE companies to apply for faster approval, who haven't even applied yet..
      Monday--who knows.

      Sentiment: Strong Buy

      • 1 Reply to paris1785
      • Exactly. By faster approval you're referring to Breakthrough designation there....Chris has been noting the FDA input into the design of the trial for a long long time - just not so much lately. He's only being coy about it now that the audience is getting too big and doesn't deserve it, it a way....at this point. He respects the market mavens' right to play their end-games is one way of looking at it, I think.

 
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