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Sarepta Therapeutics, Inc. Message Board

  • zwerp2000 zwerp2000 Feb 14, 2013 8:27 PM Flag

    New article tweeted by Jenn McNary. Meeting FDA friday?

    Posted: Feb 13, 2013 4:55 PM EST Updated: Feb 13, 2013 8:12 PM EST

    By Bridget Barry Caswell - bio | email













    WASHINGTON -
    A Vermont mom will have to wait a few more days before presenting her petition to the Food and Drug Administration.

    Jennifer McNary of Saxtons River wants the FDA to accelerate approval of a potential breakthrough drug for children with Duchenne muscular dystrophy. Two of McNary's sons have DMD, but her older son, Austin, did not qualify for the eteplirsen clinical trials because he uses a wheelchair. So, while he declines, her other son, Max, who IS taking the drug, continues to improve.

    McNary was planning to present her 170,000 signatures to an FDA representative Wednesday morning during a meeting on Capitol Hill.

    "It was really emotional. Lots of tears. It was also really empowering to be able to speak. The FDA did not show up, but we still do plan to deliver the petition in a private meeting with the FDA that another nonprofit group called the Abigail Alliance has been able to set up for us," McNary said.

    That meeting is now scheduled for Friday. McNary says she is hopeful the FDA will expedite approval of the drug. But time is of the essence. Her son Austin is now 14. The average age of survival with Duchenne is 20.

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