NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Yep. Its the other scenario given the wording of the clinical trials.gov and the protocol potential pseudo-progression patients reported (Thanks to John's link). It also seems somehow…..more possible since the hubbub here a little while back….say no more…say no more. Its the other trial design option.

Its not as complex as it sounds, since only arms 1 and 2 are used statistically for the primary and endpoint. You already knew about the cross over arm, that's arm three. That leaves the enrolled pseudo-progression suspicious tumor patients, at post chemoradiation week four MRI, who have real tumor progression ruled out around week 12 or so. Of course, if these folks are analyzed separately, as clinical trial.gov states, and they are blinded as a couple patients report, then their experimental and trial arm would very probably be used as a tertiary endpoint. Maybe the 240 patients are arms 1 and 2, and the added 71 patients in arms 4 and 5 are the former pseudo-progression patients. The 66 event trigger would only come from the 240 patient group.

I should mention that possible scenario made me go back through my thinking again….but all is well, at least in my mind. I have not moved a penny of my investment for NWBO. See last few posts.

I will also address what such an alternative possible trial design means for f3tt3f's concern regarding
methylated MGMT. It took me a while to figure it out this weekend, but I am now confident such an alternative possible trial design still works just as well regarding that subtype. (Probably tomorrow or sooner).