Replies to post #421724 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

I know two things for certain. First, the only rationale explanation ever offered regarding the Halt in use of Placebo during the screening and randomization phase of the trial is that the DSM saw a clinically meaningful difference in death rate between DCVax treated patients and placebo treated patients and called for a halt of the trial. LP refused the halt and the rest is history.

A couple huge issues about what yu know for certain is a fact.

First, CVM has an identical set of events, and the root cause was none to a futility finding leading the FDA to no longer allow new patients despite the trial continuing. And the hold was lifted once CVM changed the IND so it was no longer enrolling. Kind of makes it hard to rule out as a possibility

Second, if there were more deaths in the placebo arm, that would be attributed to efficacy of DCVax-L, not a safety issue as the placebo has been well studied and the only issue is if it improves outcomes. If you meant an efficacy rec, then that would imply the data back over 6 years ago was overwhelming such that the trial would be approved. In that case, why has LP run this out forever and changed the endpoints?

[Hspooner]

MI, I'm 99% certain that the trial enrollment was halted due to pseudoprogression, and if it turned out patients were in fact getting worse, the trial would have failed. It turns out pseudeoprogression is very common with immunotherapy, it just wasn't very well understood in 2015. NWBio could not say that it was pseudoprogression and that the patients were actually responding to treatment without compromising the integrity of the trial. (LP said "they turned a good thing into bad") This trial is an incredible success!!!
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6936240/