NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

#1. PFS failed

I have no issue with the position that PFS failure did not indicate DCVAax-L did not work. Hell, AVII77 said it would be a reason to suspect it DID work.

#2 Endpoints changed post hoc

You think being changed prior to unblinding makes it OK. Wrong. What is an issue is changing them based on information from the trial. And that did happen as NWBO knew whatever went down in 2015 and almost certainly that meant they knew PFS failed.

#3 The RAs will not allow ECAs

They will allow ECAs. No argument. But they require a lot of care to be defined and executed well. In addition to the above consider this. One key in a trial DESIGNED for ECAs is patient selection. In randomized trials, one can do what they want. But for ECAs, they must be careful to allow a match.

In this trial, they only enrolled patients with intent for near complete resection. The comparisons did not match that, and it is a very real factor.

#4 Trial treatment vs placebo

The OS in the blended population was better than the OS in the treatment population. You can spin as much as you want, but that is simple and clear.