Replies to post #421787 on NorthWest Biotherapeutics Inc (NWBO)

[newman2021]

had the hold was for failure, I bet FDA would not have lifted the hold. Sure, would not have let them continue a failed trial for 6+ years as it is 2021 now. This is one reason as well that I am buying.

[exwannabe]

Yes, I believe you are 99% correct. That is the most logical explanation to what has occurred.

I do not disagree with that. But that implies NWBO knows the trial failed the pre-defined primary endpoint.

It would still be OK to continue on and hope for OS to save the day. But it would be OK to redraw the protocol after that to avoid the primary would be considered post-hok on an attempt to approve based on it.

That would not matter for the protocol change submitted to MRHA and PEI as all they care about at this stage is patient safety. The FDA though, by law, must also evaluate the change of a pivotal trial wrt getting approved.

[Hspooner]

Smokey21, I’ll add some additional information to my theory, I believe it’s a logical conclusion that the rest of the patients only receive treatment, it would be unethical not to treat patients if you know the treatment is working. I’ll defer back to Doc Logic and his reference to the 17 patients