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Ohr Pharmaceutical, Inc. Message Board

  • hugeman99 hugeman99 Nov 12, 2013 7:30 AM Flag

    Off Topic -- SRPT down $10, the FDA will require full PhIII trial

    SRPT down $10 premarket.

    I've previously commented on SRPT here. Essentially they have been lobbying the FDA to approve Eteplirsen for Duchenne muscular dystrphy based on a tiny nine subject PhII trial that only showed statistical significance IF you stripped out two non responding outliers.

    This morning my faith in the FDA is confirmed. As much as SRPT management tried to massage the data and lobby the FDA by creating a groundswell from families of DMD suffers, the FDA will require a full placebo controlled PhIII trial.

    What grinds me about SRPT managment is their refusal to agressively pursue a parallel PhIII trial path while pursuing their questionable attempt for early approval. I think they have really deceived DMD patients/families.

    If SRPT management weren't such jerkwadds, they could already have the PhIII trial enrolling patients. With their arrogant attitude it's now still months away. Sad day for DMD suffers.

    I was away from the screens when the news hit. Wasn't able to get a short trade off at a good price. SRPT dropped another $3 as I write. Not sure where it will settle with need for a 2 year trial. Don't get me wrong, I and many think Eteplirsen probably has efficacy, but geez, you need to have some solid data to back it up!

 
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