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Sarepta Therapeutics, Inc. Message Board

  • simp08801 simp08801 Apr 27, 2014 9:00 AM Flag

    got 5 minutes

    read the Srpt pr again

    the message seems clearer to me after rereading the pr with a one week break

    when your expectations are grounded in reality, I am not sure how we could have reasonably expected any more than what this pr provided

    the odds of FDA providing AA solely on to-date data set appears remote (you can criticize this all you want but appears to be the message to me)

    having said that, the FDA has done just what woodcock once alluded to, which is the concept of "show us"

    and the FDA appears to have told Srpt just how it can "show" the FDA, in a relatively short period of time, why its to date data is in fact worthy ... in essence, do it again

    the other clear message I get is that with regards to take and measure dystrophin, the FDA and Srpt will agree on exactly how to do it ... IMO, this is the MOST important message in the pr

    and in connection therewith, the 4th biopsy on the P2 boys seems megla important ... seems like the FDA told Srpt that if you do the 4th biop with our agreed upon methods, and it matches the 3 prior biops you did that we still question as to validity, then we are likely to accept the first 3 too

    lastly, my take is that if the 4th biop on P2 boys is done and shows acceptable dystrophin restoration ala FDA accepted methods, and also the P2 144 week data continues to show the continued stability trend, that the AA filing is a lock

    whether the AA actually gets approved in mid 2015 will additionally be dependent upon the new trial data that will become mostly available after the AA is submitted

    make no mistake, it appears the AA submission will tie to 4th biop and 144 week data

    IMO, this will be very difficult to bet against if those two data points are bullish

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    • I generally agree with you, except:
      1) AA filing will only depend on results of the 4th biop from the ongoing p2 study since this is the only new data requested by FDA for AA filing. There is an unlikely chance that the 144 week walk data is deteriorated dramatically which might prevent the AA filing. But both FDA and SRPT do not expect this even remotely.
      2) A stability of 144 week and 168 week data will gain FDA approval.
      3) The new studies will not be completed before the approval. FDA did not require/expect them for the approval.

      Sentiment: Strong Buy

    • you have to separate out what data will drive the FDA acceptance of the AA app by year-end, from what data the FDA will drive the FDA approval of the AA app by mid 2015

      as to the FDA filing, it seems to be all about the 4th biop and 144 week data to me (168 week data could possibly come in before year-end but this is uncertain)

      FDA acceptable dystrophin data off the 4th biop opens the filing door

      144 clinical data pushes etep through the door

      all the new trial data will not be baked in time for any meaningful contribution to the analysis for the filing by year-end

      this all makes perfect sense to me

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