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.