NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

False -- Dr. Liau's SPORE trial is using a PFS as the primary endpoint. NWBO's just peddling an excuse because they were going to fail their P3 trial's primary endpoint and needed to find some other endpoint to save the company. They even made up an ECA to make their change to OS look better. Multiple trial's in the ECA used biopsy as acceptance into trials, when NWBO only accepted full resection that has longer survival. It introduced significant bias into the trial and was done when the trial was virtually complete INSTEAD of FDA requirements of preparation and approval BEFORE THE TRIAL BEGINS.

It's the reason FDA wouldn't accept the P3 trial as sufficient evidence for commercial review. So NWBO ran off to UK to have a chance of approval. MHRA hasn't been part of the trial oversight, so they are unaware of all the NWBO trial manipulations.