NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Diver,

I agree with you that effectively their was no control, but with that being the case, how did the regulators allow this to happen in the first place. I suppose it was because PFS was the primary goal, and control patients didn't cross over until they were judged to progressed, so all controls could have been judged to that point.

I don't know if pseudoprogression was ever seen in the control group, or only those on the vaccine, has that ever been established.

OS clearly includes those who crossed over, but if you really want to know the best the vaccine can do in this protocol, you ought to look at how well it did in patients who began the trial on the vaccine. I believe any statistics we've seen up to now has only been based on everyone in the trial combined as the clinicians were blinded as to who was receiving the placebo. I don't know how much better the numbers may be, but I've got to believe it's better to get the vaccine from the beginning of treatment.

To me it's clear that when the regulators allowed the primary goal to become overall survival they agreed to use historical data rather then the control, so there should be no debate about that.

Gary