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Sarepta Therapeutics, Inc. Message Board

  • vvvvvvrebel89130 vvvvvvrebel89130 Dec 7, 2012 2:58 PM Flag

    i think the fda's breakthrough designation is srpt; note the maufacturing comment

    drug manufacturing could be the rating limiting step; well, we've had a lot of discussion on that and on several calls chris has focused on the maufacturing issues

    i think srpt got the breakthrough desigation
    thanks to previous poster for the reminder

    FDA issues first breakthrough designation

    Published on Wednesday, November 14, 2012
    FDA has "recently" issued the first breakthrough drug designation, Janet Woodcock, director of the Center for Drug Evaluation and Research, said on Wednesday. She said the agency cannot disclose the sponsor or drug candidate. The breakthrough designation, created by the FDA Safety and Innovation Act, commits FDA to collaborate with a sponsor to accelerate product testing and development (see BioCentury, July 2).

    "Drug manufacturing could be the rate limiting step" for implementing the breakthrough drug pathway, Woodcock said at a meeting sponsored by Friends of Cancer Research and the Brookings Institution's Engelberg Center for Health Care Reform. FDA will work with sponsors to improve the chances that manufacturing is scaled-up and approved at the time when breakthrough drugs are approved, she added

    Sentiment: Strong Buy

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