NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

NWBO trial NOT adaptive -- from clinicaltrials.gov:
"Study Type : Interventional (Clinical Trial)"

The crossover was ONLY for rescue medication when recurrence happened. The trial was only designed for NAIVE GBM. They only added the recurrent GBM arm after they data dredged it from the crossover and suddenly there was a recurrent GBM endpoint. That was done after unblinding and had 15 months of data dredging time to look for any positive data they could find. It is only 64 patients. And they had to add an external comparator as they didn't have a control comparator.

They did not report the full protocol, endpoints, specific comparator and final SAP until March 2022 after they had 15 months of data dredging.

It's a manipulated trial that is not going to be well received by the FDA.