Petition calling for the FDA to accelerate review of eteplirsen may fall short


Parents of children suffering from Duchenne Muscular Dystrophy call for the FDA to accelerate its review of Sarepta Therapeutics' (SRPT) eteplirsen. Through their "The Race to Yes" campaign, they plan to petition the White House for a response to the issue. As of March 18, they have 43,750 of the required 100,000 signatures they need by the March 29 deadline.

SRPT shares plunged 64% on November 12 when the FDA notified the company not to seek accelerated approval.

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Comments (7)
  • Western Investor
    , contributor
    Comments (55) | Send Message
     
    Not sure that this is a newsworthy item. Either way you could have at least included a link to the petition if this was really necessary. http://1.usa.gov/1czsJzJ
    19 Mar 2014, 12:11 PM Reply Like
  • Long Term Bio
    , contributor
    Comments (629) | Send Message
     
    I can see the rush for drugs to help people that desperately need them that have a disease with limited treatment options, at the same time you don't want to sacrifice safety for treatment. FDA has to make sure it is safe and doesn't cause even more harm.
    19 Mar 2014, 12:29 PM Reply Like
  • hardfocus
    , contributor
    Comments (9) | Send Message
     
    Eteplirsen has shown no side effects at all ...after 2 yrs of use and also observed in other studies as well.
    20 Mar 2014, 08:12 AM Reply Like
  • pat walsh
    , contributor
    Comments (341) | Send Message
     
    I am shocked how the FDA is dragging its feet while children with DMD are being condemned to wheel chairs and early death.This is nothing short of criminal.
    19 Mar 2014, 01:02 PM Reply Like
  • LawNY
    , contributor
    Comments (2) | Send Message
     
    The good thing is that they now have people like Gregg Allman, the Allman Brothers and LL Cool J asking their facebook followers to sign the petition. It will be tight but with the push of the Allmans and others they can hopefully make it.
    19 Mar 2014, 01:05 PM Reply Like
  • linckster
    , contributor
    Comments (7) | Send Message
     
    THEY'LL MAKE IT. And I hope every shareholder in biotech stocks who also happens to be human and give a damn about investing in things that are good for kids, people and the world tries to help them. There are NO bad side effects showing up in any of these dozen or so kids (after more than two years of testing), and they've stabilized (which is truly incredible), and their parents are faced with what? Gee, certain decline and eventual early death of their children, OR… what seems to so many (including enough knowledgable medical professionals) as a pretty decent shot at saving them. The FDA needs to take a deep breath, think clearly and take a ground-breaking step in a new and enlightened direction with this one. Here's a link to the petition, I think: http://wh.gov/lEfaZ
    19 Mar 2014, 09:18 PM Reply Like
  • nick 9132
    , contributor
    Comments (70) | Send Message
     
    It easily passed the 100,000 threshold. We now await a response from the government.
    31 Mar 2014, 12:18 AM Reply Like
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