It ain't that simple. NWBo has to deal with considerable issues with this trial. Manipulated protocol, comparator, endpoints and SAP, confounded naive OS,
post hoc data dredged recurrent GBM OS when the trial was a naive GBM trial.
FDA does not like protocol manipulation and NWBO did EVERYTHING differently. NWBO knows it. As they said in the SEC filing: "There can be no assurance that regulatory authorities will allow a product approval to be based upon this approach."
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