Tuesday, December 26, 2017 4:50:29 AM
Someone has to break the mold b/c the current new product introduction/FDA trials process clearly does not meet our patients needs. IMO, Dr. M. saw the PD off shore trails as a rational and effective alternative. I am not a big conspiracy guy but something is fundamentally wrong when the only people who can afford to complete the FDA trials approval process are the BP competition. Alternatively, if A2-73 was evaluated and prioritized for trials approval based on peer/academic/P1 (PD/MS-effectiveness potential) then we have a balanced process. If A2-73 blows the doors off anything BIIB has in the chute then why isn't the FDA or someone like them stepping in to advocate evaluate and define an alternative process for MS accelerated testing? Same ol, same ol.....money talks.
IMO, breakthrough trial should not be controlled or managed by a regulatory body. If they fail then you have the answer, but if they show promise the priorities are self assigned.
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