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Sarepta Therapeutics, Inc. Message Board

  • bionerd51 bionerd51 Apr 16, 2013 9:51 AM Flag

    Bottom Line...

    No one should have expected an approval yesterday. SRPT was looking for guidance from the FDA on if/how to apply for AA. The FDA gave them guidance WITHOUT delaying the expected AA approval timeframe. How is it that many here are concluding that this is bad news? That's ridiculous. The FDA is basically stating that they will decide AA on the current PhaseII trial. Isn't that the best case scenario that all longs have been hoping for? Asking for additional safety data and support for dystrophin as a surrogate marker for Duchennes is a home run. The only negative is that our "CEO of the Year" [give me a break] didnot come prepared to the FDA meeting. He should have been prepared with NDA quality/quantity comprehensive data and he wasn't. FDA's queries are about as positive as I've seen in AA at the post-PhaseII FDA meet.

    Sentiment: Strong Buy

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