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Sarepta Therapeutics, Inc. Message Board

  • greyzone513 greyzone513 Feb 24, 2014 8:13 AM Flag


    As announced by CG in November, the FDA decided it was "premature" for SRPT to file an NDA based on two things. A) the fact that Drisaspersen data showed ample dystrophin production without the expected positive clinical impact. And B) that the natural history, as shown in McDonalds study, and/or as understood by those in charge at FDA, could be used to explain the stability shown by the 12 kids in the Eteplirsen study.

    Thing is, both of those pillars to the FDA argument were shown to be downright false. Period. The tactics that were used to get the FDA to the point where they believed A + B, were also shown to be questionable. Beyond
    A + B being shown to be absolutely incorrect, we also had the FDA visit during the stellar 120 week 6 mwt testing. GSK abandoned RNA like Miley Cyrus gets rid of outfits. And.................the FDA got a preview of what ANY panel would recommend when 7 of the absolute brightest minds in the world all agreed that this drug works,and the kids need access to it NOW. Lastly, Bastings and his anti-SRPT no matter what agenda were sent away by JW.

    Logic would dictate, that if the foundation for your reversal is shown to be absolutely false, while the data for Eteplirsen continues to literally shine, and the brightest DMD minds all agree the drug works with an astonishing lack of side effects, the FDA should then find themselves exactly where they were prior to being misled by A + B.........................waiting to receive the NDA from SRPT for Eteplirsen. Best of all, the data supporting Eteplirsen is now WAY better than it was when the FDA originally suggested that an NDA should be should be submitted. What argument against approval is left? BAstings just hates SRPT and doesn't care about proper protocol or data? Zero side effects MUST be a lie? The argument against AA seems to have crumbled since November, leaving only one valid choice - AA.

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