NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

It’s not relevant at this stage. It’s just them crying because the trial still proved a survival benefit after extension for a number of years, instead of an early approval with a phase 4 to prove benefit, which is how that works. We saw numerous immunotherapies that had been approved on PFS grounds that ended up NOT having the survival benefit that was assumed for their approval. Some approvals were then undone, and many continued anyway, for other reasons including quality of life. Almost all of the big drugs have those issues in trials.

So NWBO let it run, not because it failed but because the secondary could be primary, but they still needed a control arm, and the regulator allowed them to seek a blinded, expert, outside epidemiological and statistical firm to create that arm with a very large number of concurrent and similar trials. There are still jealous competitors wandering about because of it. And we see them every day.

Their anger has nothing to do with the validity or the statistics or the proof. It’s pure jealousy.

PFS is a surrogate endpoint for OS. It was not a real endpoint. It was for getting an early decision.

https://www.onclive.com/view/fda-will-reassess-6-immunotherapy-accelerated-approvals#

https://www.ajmc.com/view/fda-panel-votes-to-keep-4-of-6-dangling-approvals-in-a-sign-of-things-to-come

In the case of DCVax-L, they still had to do the statistical study, and in a way to eliminate “bias”, which they clearly took pains to do, with the blinded, outside, expertized statistical and epidemiological firm. And they needed to let the data run to get 5 year survival data. I don’t think the 5 years was set in stone but clearly seemed prudent to those advising. The end result, was, as we saw, excellent survival data that rivals will of course attack, because that is what “rivals” do. But they know that regulators cannot and should not reject based on their bad faith critiques. Of course, my opinion only.