FDA is run by bureaucrats and some scientists.
Trials are stopped for patient safety issues, for interim analysis success and futility. That is done by the clinicians running the trial NOT the sponsor.
NWBO changed all the protocol after the trial was virtually completed -- they knew they were going to fail the primary endpoint so they tossed it out and redid all the trial protocol, endpoints, comparator and SAP. No regulator is comfortable with sponsors changing all the rules of a trial AFTER it was almost over.
Just what what is going to happen.
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