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nidan7500

05/15/22 8:38 PM

#360412 RE: Steady_T #360411

there is a process that drugs have to go through to approved and licensed before they can go on the market.



We are all aware of the FDA process requirements. Sad to say the FDA trials process is flawed . Refer to the requirements outlined in the recent AVXL patent app. Perhaps the FDA should study it for useful guidance on measuring-evaluation and controlling patient CNS disease go/no-go treatment efficacy.

IMO, many here would be delighted if the FDA trials process had proven anything clinically useful over the last 30+ years but it has only served as a dead end street. Approval of new/ alternative effective process requires an act of congress. That has been a hard stop dilemma for some. If the FDA process was effective at clinically providing anything we would have a solution by now.

Hope to see change soon.