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Sarepta Therapeutics, Inc. Message Board

  • shimp41 shimp41 Apr 30, 2013 5:17 PM Flag

    Data on boys in posession of the FDA

    In questions after the Needham conference, Chris said the FDA aldeady has data on the individual boys except the 74 week results which are being complied now. I believe he also said that the white paper on industry R&D included a recent natural history paper. The implication was that the FDA also had the white paper. He specifically said that the FDA told him that they will consider an Accelerated Approval filing after they have the information they requested. Finally, he said that after they receive this last data they will have almost everything Sarepta has and enough for a New Drug Approval.

    Sentiment: Strong Buy

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