Replies to post #767562 on NorthWest Biotherapeutics Inc (NWBO)

[Arby2000]

And sure as shit the regulators don't like it when you introduce massive confounders into your study.

Bunkum. If you knew the history of this trial as well as you pretend to know, you would know that it was, as has been pointed out ad-nauseum on this board, the FDA that required control arm patients to be crossed over to the treatment arm when they progressed, thus introducing the confoundment that you decry. So, it was not introduced by NWBIO but effectively by the FDA.

I am also of the opinion that LP knew who at the FDA was pressing for it. Because, even though it could be framed as an ethical move, any clinical trial statistician would have quickly figured out that it would lead to confounding of the control arm and treatment arm results - creating statistical analysis issues and approval by the FDA. Hence:
1. The move to five-year OS for the trial duration and endpoints.
2. Use of ECA to unwind the confoundment.
3. Move to MHRA to end-run whoever was at the FDA requiring the crossover. Once MHRA and RA aligned with it approve it, FDA would be in a pretty untenable situation to not approve it. And, yes, I realize that there are treatments approved elsewhere that are not approved by the FDA, but also vice versa - see Novocure's Optune.