NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Progression-free Survival (PFS) was an INITIAL endpoint ...

PFS was the primary endpoint and used in the 2015 efficacy IA. Had it been a success they would have submitted for approval based on it many years ago. But the trial failed to establish the endpoint and the reason does not matter.

Only after that did they change the endpoint. And doing so after an efficacy analysis is a cardinal sin in trials. Sure, they can blame the change on whatever. But any RA is going to seriously question if the change was influenced by the failure of the IA. Does anybody really believe they would have changed if it had worked in 2015?

There is no question OS is a better clinical metric. But that does not change the fact that it was not until after the trial had failed the primary PFS in 2015 did they change it.

BTW, on a related note longs might wonder how the company provided data from P1/2 trials that showed a 24 month PFS vs the under 7 months in the P3. Does not matter now, but kid of sounds like they were more interested in cooking numbers in the P1/2 than actually trying to find best how to run the P3.

Oh, we can queue the "PFS does not matter" responses. Replying in advance, the primary endpoint at time of the .first efficacy analysis matters a hell of lot, regardless what it is.