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akasidney86

04/30/14 12:19 AM

#3287 RE: pistol1p #3286

I'm a relatively new (3 mo) holder, but it seems to me that the most likely pertinent data is as Pistol supposes... that the 24 month p value is over .05. That being said, it seems to me that the way forwards with the FDA will still not require a large P III, and a filing could be made based strictly upon the stat sig 12 month data, known MOA, clean safety profile, and known profile of copaxone. A nearly 50% improvement over SOC is nothing to ignore IMO.