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Sarepta Therapeutics, Inc. Message Board

  • casey_loulou casey_loulou Nov 12, 2013 3:51 PM Flag

    Question about what happens with the current trial patients

    I was wondering if the current trial patients will still be able to continue taking the drug or not during a Phase III trial? Will they automatically be enrolled in the next phase or will they possibly become ineligible?

    I am really upset that the FDA is playing with these kids' lives. I really hope the boys who are showing improvement in Phase 2b will be able to continue the drug going forward.

    Sentiment: Hold

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    • The boys in the current trial get to take the drug as long as they want. I think the company has to formally extend the trial - they mentioned on the call that going forward they will only be getting 6MWT and other data every 6 months, so the next data point will be 120 weeks.

      • 1 Reply to tredleon
      • tred

        I do not think the boys in the current trial are any longer safe in terms of being guaranteed to receive the drug for any material length of time

        it seems clear that from this day forward, the FDA will unilaterally 100% dictate every aspect of every and any future trial

        future trial designs could be so divergent from theh P2 structure that for resource conservation purposes, that trial could be eventually discontinued




    • Again, stop blaming the FDA. I think SRPT got their hopes high because of the anticipation that AA will be done.

      But, it isn't.

      FDA hasn't really DECLINE the AA yet. But, they're suggesting that SRPT needs to provide more convincing data so that it can be likely approved in future.

      So be patience. This is a good lessons for any biophama who wants to jump the queue.

      Sentiment: Hold

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