NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

All patients are told at when they sign up they will get a rescue medication if they have recurrent GBM. The original trial was ONLY for naïve GBM. It was only after they unblinded the data they data dredged a recurrent GBM arm using the 64 placebo patients from the naïve GBM arm. NWBO could not have known the about the rGBM data until unblinding post hoc.

PFS is one of the 6 FDA accepted endpoints (tumor cancers) for approval consideration. NCI and UCLA (Dr. Liau) are using PFS as the lead efficacy endpoint in their rGBM Keytruda combo trial.

NWBO has called their OS data confounded by the crossover as some patients that were DCVax-L dosed were redosed if they were pseudo-progression and therefore received multiple doses. It they had true progression they also had a 2nd dose. That would the confound the reading of the naïve GBM OS arm. That's where the FDA may find the results are questionable because of the multiple dosing that could increase the OS rate. When a placebo treated patients did not have multiple doses.