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Sarepta Therapeutics, Inc. Message Board

  • biony1 biony1 Jul 24, 2013 5:47 PM Flag

    Thoughts on CC

    Make no mistake CG has done a brilliant job to date but the CC was a major misstep.

    The messaging should have been along the lines of:

    We are excited and pleased to announce that Sarepta has decided to submit an NDA for eteplirsen in the first half of 2014 based on our encouraging and positive discussions with FDA which focused on the strength and statistical significance of our surrogate and clinical data from the eteplirsen Phase IIb study and the acceptability of this data for an NDA filing.

    While FDA has not yet decided whether dystrophin is a surrogate marker reasonably likely to predict clinical benefit, we note that FDA has multiple options for approving eteplirsen including on the basis of the 6MWT clinical endpoint.

    Today marks what we truly believe is a major step forward for the DMD community as we seek to establish eteplirsen as the (first and ) best in class therapy for (exon-51 related) DMD etc....

    In other words,the focus should have been on the certainty and confidence of your decision to file for an NDA rather than expound and expand on potential FDA issues that will, by definition, be uncertain at this point.

    The Street's Adam F. already established that a nod from the FDA signaled a de facto approval for all intents and purposes. A very nice baseline to work from. The CC only served to call this into question and raise more questions and issues than answers--a feast for bears.

    The CC should have been short and to the point. Instead, gold was spun into straw as certainty was transformed into uncertainty.

    In this case, less would have been more...much more.

    Sentiment: Strong Buy

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