NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

Well post hoc data dredged rGBM OS is not going to be sufficient for approval. The small sample (n=64) is not sufficient for a pivotal trial for application for approval.
Had this trial actually been designed for recurrent GBM then the proper sample, protocol and SAP would have been in the original trial protocol. But here is the name of the NWBO trial: "Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer (GBM)" This trial had no intent of assessing rGBM until NWBO manipulated the trial based on the data dredged rGBM data that was a byproduct of the trial -- not the purpose.

rGBM analysis was data dredged post hoc -- fine for drawing inference for future trials, but not for approval itself.