The PFS primary endpoint was tossed out AFTER the trial had been run -- after all data had been gathered.
NWBO may file data with the FDA, but the FDA won't approved a trial protocol after the trial is completed. They will review it when NWBO files it in their application for approval. NWBO has repeatedly said the changes were made a risk with no regulators signing off (SEC Filings).
FDA Guidance clearly states that PFS is an approvable endpoint along with five other endpoints including OS. NWBO has also repeatedly report that the naive OS data is confounded and also at risk that regulators won't approve it.
I'll listen to NWBO's SEC filings done under oath and penalty of perjury.
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