NorthWest Biotherapeutics Inc (NWBO)

[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.