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Sarepta Therapeutics, Inc. Message Board

  • tredleon tredleon Jan 15, 2014 10:29 PM Flag

    It is Clear Why There are no Minutes

    The standard protocol is to provide minutes within 30 days, so why nothing from the FDA? Based on the parent and researcher responses at the PPMD meeting, the response they likely got from SRPT management in their meetings and the general buzz in the community, they knew they missed the boat completely with the last minutes they provided the company, so they wanted to wait to see the 120 week data before potentially digging their grave further. At this stage of the game, if they came out and said the 6MWT natural history data is consistent with SRPT's 120 week data would be laughable. As CG pointed out in the conference, even GSK's data for the 7+ aged boys showed an 80M decline in 6MWT over 48 weeks. So, where does that leave them - do they continue to denigrate the dystrophin data, without providing any alternative measures that can be utilized in the confirmatory trial? Do they acknowledge the 6MWT is compelling but try to argue an insufficient trial size, something they've known from the beginning? There is no reasonable response they can come up with against AA that doesn't make them look foolish - they are between a rock (robust, consistent clinical data) and a hard place (the wrath of the DMD community), which is why they can't figure out what minutes to provide SRPT management.

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