I agree w/your insight on small world we live in. We speculate about what is at stake w/new FDA trials rules/new S/W being put to use and concepts like Homeostasis being brought to the field.
IMO, new trials rules will not be pass/fail like the old days. I do not know what they will be but expect evolutionary results rather than binary only. There will likely be a more detailed prediction on what should happen with pts which may shift emphasis from a room full of experts decisions to decisions based on how patients feel, move, function, perform
In any case, the FDA is now in the hot seat. Any Biotec that gets too far out in front of the new rules will be roadkill, IMO. They are damned if they do/don't. The good news is, IMO we will not have to wait for years to get results b/c the new process is what matters. If establishing homeostasis in CNS disease patients is an effective treatment then the outcome is certain. Predicting Other symptoms that develop flowing CNS cellular stability will have to remain what we do not know we do not know for the time being. Process monitoring and controlling will be critical. Trust the process.
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