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Sarepta Therapeutics, Inc. Message Board

  • mazmike147 mazmike147 Nov 18, 2013 1:00 PM Flag

    Is Drug Manufacturing Continuing?

    Does anyone know if SRPT is continuing this effort or has postponed it based on FDA Guidance? If continuing, when is the expected date for it to become available to the masses?

    Sentiment: Hold

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    • I think it's fair to assume that full scale ramp up is no longer required or wise, until
      a viable path to approval at least exists - which is no longer the case. Beyond that, assuming CG has to slam the brakes on production, there will likely be hefty fines built into those manufacturing contracts that SRPT will now have to pay.
      Factor that plus the money/man hours wasted trying to put together a well packaged NDA for submission early next year that they no longer need, and you have TWO large wastes of money that SRPT can thank the FDA for as well.
      A simple "no, go run your P3 with these FDA approved endpoints" would have been far less sinister and helpful. But no.....the FDA preferred to jerk the parents, kids, and SRPT around first, and flaunt their disregard for FDASIA. From where I sit, the FDA has wasted plenty of SRPT's time and money by suggesting an NDA was a viable option, when in fact, it was only an option when they thought their favorite - GSK - would make it to market first. Once GSK exploded, the FDA decided to change the rules of the game by conveniently misinterpreting "new" data. Freaking travesty.

      • 5 Replies to greyzone513
      • My understanding is that full scale manufacturing CMC is not required prior to P3 testing. What is important is to establish scalability of the process and stability of the product. Go back and listen to the conference call. My recollection is that the FDA had indicated some flexibility in stability testing which is where the time factor is most in play. So to answer your question, manufacturing is continuing. But the pace may be reduced now due to some uncertainty about when product supplies need to come online.

      • "From where I sit, the FDA has wasted plenty of SRPT's time and money by suggesting an NDA was a viable option, when in fact, it was only an option when they thought their favorite - GSK - would make it to market first. Once GSK exploded, the FDA decided to change the rules of the game by conveniently misinterpreting "new" data. Freaking travesty."

        Spot on Grey. The minute GSK was out---the FDA was like SRPT who??? Travesty indeed!

      • grey

        I do not see how, based on current public disclosures, any material company expenditures on near-term manufacturing capacity would pass muster under the "fiduciary duty" test

        absent further clarification from the FDA, Srpt could be multiple years away from need for commercial manufacture capacity

        its a terrible unexpected truth, but a truth nonetheless

        preparation for drug production beyond that needed for the P3 (whatever that becomes and whenever it becomes that), cannot be reasonably justified at this time

        Srpt needs a humdinger of an FDA meeting this month to get any clarity
        JMO

      • that would be have been my assumption but would be telling if they decided to continue and what message that would send.........would tell us whether the company thinks it has levers to pull to still get this through...maybe a job for Simp!

        Sentiment: Hold

      • Pretty succinct summary. The FDA's actions were truly shameful. Had they just denied AA from the get go, I imagine P3 could have started much sooner. But now the boys have to wait another several months thanks to the FDA. Wonder how many will lose ambulation (or worse) in that time. Truly despicable.

 
SRPT
14.08+0.02(+0.14%)Mar 5 4:00 PMEST

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