NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

because the FDA told them DCVax doesn't work at the IA.

Well, to get the details straight, the DSMB would have reported in 2015 that the trial was not going to be able to establish the primary endpoint of PFS. The FDA was not involved then.

When the FDA would be in the picture would be when NWBO discussed what to do. Almost certainly attempting to change the primary to OS. That is why LP stated they were hoping for initial screening to resume soon. At that point the FDA such a change was unacceptable as the patients would then be signing a consent for an OS endpoint the FDA considered not to be a valid well controlled trial so it would be unethical for patients to sign that initial consent form.

But clearly randomizing patients to placebo would not be ethical as the placebo arm could no longer serve any purpose with the randomized trial now futile.. And nor could patients sign the consent form to do so. This did leave a practical issue for the patients in the pipeline. The FDA took the pragmatic approach on that and allowed them to have treatment.

Later, when patients were no longer being enrolled, the FDA would allow the change as they are legally required to do for a protocol change that poses no harm to patients.

And so around the end of Sep 2020 NWBO finally changed the endpoint. And the FDA said "whatever, there are no more patients being treated".