Replies to post #28694 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

"I was under the impression that if a patient was diagnosed to be a psuedo progressor, they would be moved to the 72 patient sub-arm of the current Phase III trial. Considering the fact that a majority of the patients in the 55 expanded access trial was enrolled in 2012, would that not imply most of the patients are true rapid progressors vs psuedo progressors?" -- Gnawks

The pseudo "arm" of the trial was not put in place until May 2012. The 55 information group (not expanded access arm) was filled from 2011 to that time. This still does not conclusively reflect which patients were placed in the info arm.

"Having pseudoprogression does not disqualify a patient from the Phase III trial. Thus, from that, would it not be safe to assume the majority of the patients in the expanded access arm is made up of true rapid progressors. Sure a few would still fall through the cracks, but not enough to make the current Median OS irrelevant." -- Gnawks

Again, I think you are referring to the 55 info group, not the expanded access trial. While it is true that from the start of the current phase II/III GBM trial, there were no exclusion and/or separate arm criteria/existence listed (doesn't mean they did not exist in the detailed protocol) regarding true and/or pseudo-progression until May 2012 on clinicaltrials.gov, it is certain from the info arm information given by NWBO, that "rapid progressors" and "potentially rapid progressors" (and patients without enough tumor material) were placed in the info arm during that time. The whole debate then centers on what do they mean by "potentially rapid progressors." The info arm ended up with rapid progressors, pseudoprogressors and the 4 patients without sufficient tumor material to be in the main arm -- according to recent slide presentations.

The question is, imho, were "potentially rapid progressors" placed in the info arm with the thought they were "pseudoprogressors", or/versus were the pseudoprogressors already being moved into the main trial from 2011 to May 2012 (since there was no listed exclusion criteria), and only a few slipped "through the cracks" into the 55 info arm because they were mistakingly thought to be "rapid progressors" aka "potentially rapid progressors.".

We don't know.