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Message: Re: Clicks refresh on the PPS....WoW!!!

I'm likely one of the least qualified posters on this board to chime in on the workings of the FDA, but that's rarely stopped me before from chiming in before....so.... 

I cannot see any way that, if these changes are adopted by the FDA....I can't see any way that BETonMACE would not be included for consideration.  That's not to say that, after reviewing the data, that the FDA would approve an application for Apabetalone....but I do think 208 would have to be considered, its almost like these changes were written with the BETonMACE trial in mind imo, especially the part about p-value.  

 

 

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