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HyGro

01/19/23 12:02 PM

#560630 RE: GPha #560558

A trial is to determine efficacy -- does the drug meet efficacy endpoints in a well-designed and controlled trial. NWBO's trial was certainly not a well-controlled or designed trial. Post hoc tossing out the primary endpoint and totally redesign the protocol, endpoints, comparator and SAP after the trial is virtually complete. The treatment bias is complete starting with cherry-picked, healthy nGBM patients, confounded the results by multiple doses of DCVax-L and statistically manipulated the OS to try to compensate, picking external comparators that don't do either. The bias makes the results unreadable.