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Sarepta dips after DMD program update

  • While there doesn't appear to be any clear catalyst for the sell-off in shares of Sarepta Therapeutics (SRPT -6%), investors are hyper-sensitive to any and all news about the company's DMD program, especially in the wake of drisapersen's failure.
  • The company "updated" the program on Thursday and held a Q&A session on the call.
  • CEO Chris Garabedian did discuss the idea of the FDA mentioning a placebo control arm: "We have highlighted in previous communications that we believe that a placebo arm maybe infeasible, it could significantly impact our ability to enroll the study and get through IRB approvals and possibly to get patient consent, it has risk in patient dropout if eteplirsen were to be approved. And so we continue to have those discussions with the FDA, the feasibility or infeasibility of including a placebo-controlled arm." (transcript)
  • Stifel has apparently spoken with management and confirmed that SRPT will take any action the FDA deems appropriate.
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Comments (3)
  • rrobster
    , contributor
    Comments (148) | Send Message
    Here we go again with the FDA and their stumbling blocks. First Amarin and now this.
    18 Oct 2013, 02:25 PM Reply Like
  • whosez
    , contributor
    Comments (112) | Send Message
    I would not want my child to be getting the placebo.
    18 Oct 2013, 05:45 PM Reply Like
  • badsangria
    , contributor
    Comments (135) | Send Message
    If the FDA screws this up I'm looking for a 60 Minutes segment.
    20 Oct 2013, 05:43 PM Reply Like
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