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"Race to Yes" campaign pressures FDA to act on eteplirsen

  • Parent organizers of the grass roots campaign to get the regulator to approve the drug for children afflicted with Duchenne muscular dystrophy sent a letter to FDA Commissioner Margaret Hamburg today urging her to direct the agency to expedite its guidance to Sarepta Therapeutics (SRPT +4%) so it may file its NDA. The company has been waiting for said guidance for 16 months.
  • Once submitted, the organizers want an accelerated review of the application. Currently, there are no approved medications for the disease that afflicts 1 in 3,500 boys.
  • The campaign, which was a petition to the White House, garnered over 105,000 signatures.
Comments (7)
  • pat walsh
    , contributor
    Comments (210) | Send Message
     
    I believe she is married to a hedge fund manager.no conflict there.incredible.
    9 Apr, 02:17 PM Reply Like
  • likeafox7210
    , contributor
    Comments (5) | Send Message
     
    She IS married to a hedge fund manager. So yes the Head of the FDA who over sees the nations formulary of both existing and drugs currently being evaluated for approval, as well as medical devices, has the ear of the co-ceo Peter Brown of Renaissance Technologies and vice-versa. Google him and Renaissance Technologies holdings and come to your own conclusions. Mine is huge conflict of interest!
    9 Apr, 04:53 PM Reply Like
  • Joe Lunchbox
    , contributor
    Comments (354) | Send Message
     
    I wonder why the news hasn't mentioned or investigated this?
    9 Apr, 09:10 PM Reply Like
  • likeafox7210
    , contributor
    Comments (5) | Send Message
     
    Hey Joe you are preaching to the choir. Yes I am worried about it. Think for a second!
    10 Apr, 07:04 PM Reply Like
  • JoeRapp
    , contributor
    Comments (3) | Send Message
     
    These parents are desperate, Their son's are going the die and you are worried about a conflict of interest. The drug is working for 120 weeks. Why isn't there more of an outcry for fast track approval? And if you want a conflict of interest, yes I do own shares and am proud of it.
    9 Apr, 09:33 PM Reply Like
  • likeafox7210
    , contributor
    Comments (5) | Send Message
     
    Joe you are preaching to the choir. Think though about the ramifications.
    10 Apr, 07:04 PM Reply Like
  • Stockathlete
    , contributor
    Comments (7) | Send Message
     
    Utterly absurd that there has not been a formal response/decision from the FDA. FDA: WHAT ARE YOU WAITING FOR?!?!!!! Respond YES and do the right thing, or say NO and suffer the consequences, along with the afflicted kids you buried. Either way, make a choice!
    10 Apr, 10:44 AM Reply Like
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