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Message: Breakthrough Therapy Designation Application

"Yes, but aren't Biogen's results even way more modest and even more underpowered and they are going to proceed with FDA approval anyway?  And if ours are that much better and Dr. Cummings says aducanumab is a 50-50 toss up for approval should we not at least attempt an appliccation for approval too?"

Biogen's data are crap in my opinion. It would be a travesty for clinical medicine for that data to support an FDA approval. However, Biogen is using primary endpoint data, albeit likley on a post-hoc sub-population, to support their case for approval. Resverlogix's cognition sub-study in BETonMACE was an exploratory outcome and was not primary endpoint data. I give it a 0% chance that apabetalone would be approved based solely upon the MoCA results in a sub-population of a pre-specified exploratory study of a CVOT trial that failed its primary outcome. 

BDAZ

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