NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Ex, there is no doubt that when the trial began PFS was the desired path to approval. The problem was pseudoprogression which made PFS an invalid measure.

Yes, as first designed PFS was the hopeful path to an accelerated approval.

psPD may very well be the thorn in that, but they knew of that well prior to conducting the PFS efficacy IA in 2015, and yet did not change the endpoint then. So they took a free shot on goal, if the IA had shown PFS was a success they could claim a win. And in case you forget, there were plenty here asserting it would be a success based on the blended event rate.

The regulators agreed with the company that the trial could proceed with OS as the goal.

Disagree strongly. NWBO never changed the protocol until Sep 2020, by the then the trial was long over wrt patients. For trials, the RAs concern is for patients.

What is far worse, I guarantee you that in 2015 what LP was submitting to the FDA to lift the hold was an attempt change the endpoint to OS. And the FDA said no, that would not be OK. But you will never know this.,