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LakeshoreLeo1953

06/09/22 11:34 AM

#362791 RE: nidan7500 #362790

SELF Approval....Yea, that's the ticket.

Who approves the membership in THAT club?

Bourbon_on_my_cornflakes

06/09/22 11:43 PM

#362826 RE: nidan7500 #362790

File an NDA So,, what cam they do? They drag their feet-slow walk the processes required . I am guessing but IMO, we have been pushing the envelope (even though we do it a subtle manner. FDA leadership has to find a way to save their positions in CNS medicine, after just being told that dementia is the single biggest killer.

File the NDA and we will see whether or not the FDA agrees they got the goods.