Replies to post #139712 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Jammy, safety or efficacy?

I would assume skipping a safety IA could be grounds for halting the trial.

For efficacy, the FDA allows sponsors to act as they wish on the results. So I see no reason why they would have a problem with the trial ongoing. But they might argue for an alpha penalty if it becomes a basis for a NDA/BLA submission.