NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Doc, I don't believe that pseudoprogression was an issue with those on the SOC, I believe it was purely for those who got the vaccine who were thought to being progressing, but who actually were getting better, IE pseudoprogressing. Those on the SOC who never crossed over were simply too sick or passed on before they had the opportunity.

This scenario creates K-M curves which show patients on the vaccine progressing before those on the SOC do, but it's because their pseudoprogression was called progression and that call was never reversed, even though the patient continued to improve, and may in fact be living today. It's rather like a totally incorrect call in a sport activity, once the call is made it becomes official no matter how wrong it is.

I'm frankly uncertain today if a new trial were established whether progression would be a legitimate goal because they now have an acceptable way of differentiating between progression and pseudoprogression during the trial. I don't know if some sort of intrusive activity, like multiple needle biopsies of the tumor, would be considered acceptable for differentiating between progression and pseudoprogression. If some sort of scan cannot make this determination, I believe the only goal may be overall survival, which is the gold standard, but clearly takes longer, and costs more.

By the way, by my count we're at T-59 for UK approval.

Gary