Really, the protocol was done AFTER the trial was completed -- all data gathered, all patients treated and the trial was over. That is post hoc.
NWBO has made it clear it was NOT approved in their SEC 10K SEC filing twice:
"There can be no assurance that regulatory authorities will allow a product approval to be based upon this approach."
If it was approved, they would certainly say so, but FDA doesn't approve post hoc protocol changes. Sponsor do need to file them though. That is all NWBO has done.
The 10K is filed under penalty of perjury.
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