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Sarepta Therapeutics, Inc. Message Board

  • bud_rolfs bud_rolfs Apr 16, 2013 6:35 AM Flag

    My Take on the FDA Notes.....

    First off I am VERY DISAPPOINTED.
    Second, I can't shake the impression that the FDA went "out of their way here" to give Serepta management a second chance to give them (the FDA) the right data in the format required on the SURROGATE MARKER ISSUE and ALL TESTING RESULTS. Let's face it. These are 2 pretty obvious areas that Serepta management knew it had to CONNECT CLEANLY with the agency and they fumbled both footballs in my opinion. The FDA did not want to just turn down a potential MIRACLE DRUG (and let down all those kids and families) just because the Serepta management team could not give them the CLARITY they needed on those 2 issues; so they gave Serpeta management a SECOND CHANCE.
    In the conference call, CG made it sound like "we did everything right" BUT those less RNA-educated folks at the agency need a version of how this stuff all works written in crayon. I'm not buying that, because once upon a former life; I was Director of Operations for a Medical Device Division of a high tech company in the Boston area; and we dealt frequently and directly with the FDA.
    Just my views...(and yes, I am entitles to my personal views and not just charts same as all others on this board.)
    God bless...Bud

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    • The FDA was asking for the current data 72 week ,that was not available before/ The FDA also wants a endpoint package ...this is pretty normal to me..makes perfect sense.I am very motivated by it all .I see a FDA ''aa'' approval real soon after the package .

      • 1 Reply to usagary1
      • Gary, The FDA could have very easily allowed Serepta to APPLY FOR ACCELERATED APPROVAL before knowing the 72 week data knowing they could always reject the application if that data took a sudden strange turn on safety or efficacy....Using your logic, they could ALWAYS put the application on hold for more test data. What would be so seminal about holding till the 72 week signal was out? Why not wait till the 84 week signal or 96 week signal? I guess I wish I could focus more on the silver lining today. I love thw PROMISE OF ETEPLIRSEN just as you do, but I disagree on how to frame this whole FDA notes thing I guess,
        Warmest regards though and God's greatest blessings to you...Bud

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