Seeking Alpha

FDA: Too early for Sarepta to file for approval of Eteplirsen

The FDA says that Sarepta's (SRPT) submission of a New Drug Application (NDA) for the company's Eteplirsen drug for the treatment of Duchenne muscular dystrophy (DMD) is premature following the failure of GlaxoSmithKline's and Prosensa's Drisapersen product in a Phase III trial.

The FDA also indicated that - in Sarepta's words - "new data raise 'considerable doubt' about the dystrophin biomarker and the supportive clinical efficacy assessed on the 6-minute walk test (6MWT) in the Phase IIb clinical study of Eteplirsen."

Last month, SA author EnhydrisPECorp predicted that the FDA wouldn't grant early approval of Eteplirsen.

Shares are -29%. (PR) (Q3 results)

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Comments (5)
  • TruffelPig
    , contributor
    Comments (4081) | Send Message
    I call this a real buying opportunity coming up. The PT should not have changed that much and the big picture neither.
    12 Nov 2013, 07:33 AM Reply Like
  • pagreen1966
    , contributor
    Comments (667) | Send Message
    Now down 51% in premarket.


    Might be worth trading the dead cat bounce but personally I'm going to watch this from the sidelines!
    12 Nov 2013, 08:30 AM Reply Like
  • GaryLee276
    , contributor
    Comments (154) | Send Message
    These boys need a drug that works. I hope it works out for everyone.
    12 Nov 2013, 11:32 AM Reply Like
  • TruffelPig
    , contributor
    Comments (4081) | Send Message
    Seems that the drug works for some, like Max. Agree 100% - the boys need a drug that works. This is the closest thing right now to hope for them.
    12 Nov 2013, 11:49 AM Reply Like
  • rrobster
    , contributor
    Comments (172) | Send Message
    Why would the FDA deny this drug to a population that is ensured a 100% eventual fatality rate? The FDA should be investigated for criminal behavior in regards to this and also the debacle at Amarin (AMRN). Any possible concern that the FDA has cannot possibly override the reality of what these boys eventually face. This ruling will place a huge financial hardship on Sarepta (SRPT). My heart goes out to these families. The FDA is not fulfilling their obligation.
    12 Nov 2013, 01:06 PM Reply Like
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