NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

On the subject of pseudoprogression, has it been determined to exist in patients who never received the vaccine, or only after receiving it.

I think it's clear this trial is going to be judged primarily by survival, not progression. If you agree, we need to realize that the comparison in survival will be made primarily between just roughly 33 patients who never received the vaccine, and the roughly 300 who eventually did receive the vaccine, roughly 200 initially plus 100 crossing over.

If pseudoprogression was only seen in those who received the vaccine, the need for the vaccine in those crossing over would be clear. If pseudoprogression had occurred, but wasn't diagnosed in those who crossed over when what was thought to be progression occurred, the need to cross over all those patients could be questionable.

I believe it will be clear that survival is greatly improved with the vaccine. I just hope the FDA or other regulators are uncertain that the roughly 33 who didn't cross over provide an adequate control based on survival.

Perhaps this trial could have been done far quicker if pseudoprogression was known going in. If that had been the case, it's possible the trial could have ended after XXX many patients had been determined to truly have progressed. As is, the trial has been run to the point that even the last to enter the trial did so 4 years ago. Based on progression alone, the trial would probably have ended 3 or so years ago, and even less had their not been delays.

Gary