NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

NWBO has stated over and over again that there was no interim efficacy analysis performed. Period end of sentence….this is an old and tired argument.

In my experience, interim futility analysis is performed blind to treatment. Arms are separated and analyzed to see whether a statistical difference exists or with more time has a possibility of hitting. When far outside the range, studies get killed, but when just outside the range patients get added.

What NWBO has done is analyze the entire grouped cohort data. This does not destroy the blind or provide any detail regarding the likelihood of endpoints being reached. Therefore, it did not impact how they approached building the SAP. Had they done an interim, they would not have been able to redesign endpoints to account for the lack of a true placebo given halted screeners were all treated, placebos who had not evented most likely crossed over immediately and anyone else evented and either chose to cross over or not. If they stayed in trial, they likely crossed over. The LTFU, that is a different story. They likely chose death. In today’s day and age, death can later be captured so long as they died in the country of origin for the trial. LTFU dropped between refreshes from 12 to 7. Those seven may just be lost or may end up on the KM curve when found.