Anavex is clearly an early example of what future trials will begin to look like. And yes, it does seem that we are early in the shift.
I think the question is, can the FDA sit back and watch us take the lead on this shift without helping. Without being able to say. We saw a chance to help an innovative company accomplish and set the standard for the future and we gave them the support they needed.
Or are they going to say. Wow. They did that and we weren’t there and the Aussies saw what we didn’t For some reason I believe it’s the former. The FDAs buzz words and their evolving thought on the processes involved lead me to believe something is in the works.
I can’t see how this trial will be allowed to run its course old school style.