"PFS failed to meet the endpoint and then was tossed out."
No. PFS was impossible to measure at that time. They witnessed pseudo-progression which at the time was not distinguishable from actual progression. While this was new to them at the time, it has now been seen repeatedly in immunotherapy research. When you are activating a subject's own immune system, an inflammatory response should be expected. They did the only thing they could do--they changed the endpoint to something measurable and unambiguous--the death of the subject.
I agree that the crossover arm makes the new endpoint more problematic. Once progression had occurred, the study was done for that patient so there was no reason not to offer actual treatment for placebo subjects. However, with the change to OS endpoint, you have a confounded endpoint with only a tiny in-sample control group remaining. This is the single biggest issue with the trial since it requires the introduction of an out-of-sample control. This isn't evidence of failure, but it is a confounding factor in the evidence for efficacy.
"Then there is the mystery FDA partial stop of the trial "
There is no mystery. The trial was "stopped" for the reason above. "Progression" had been observed in enough cases for the trial to have failed. The problem was that much of the progression wasn't real. As data from other studies and peer-reviewed research unrelated to NWBO became available that showed the pseudo-progression problem, FDA investigators were satisfied that the trial could continue. The pseudo-progression problem is not a convenient fiction--it is well-documented and accepted as an inconvenient reality in the literature.
I don't want to get into a debate with you if you are hell-bent on seeing a conspiracy, I'll not be able to change your mind. For the record. I hold more than ten million shares not counting warrants. I have zero inside information but do know most of the other larger shareholders. I agree with you that the single largest risk factor will be how the FDA views the out-of-sample control group. I am comfortable with the credentials and independence of the group that constructed the OOS control; it is just unorthodox. The endpoint change and halting of the study are less serious issues due to all the credible independent research supporting it (and the regulatory authorities accepting the OS endpoint change). Indeed, this pseudo-progression phenomenon is no longer disputed in the research. I've been following this company for over a decade and while I have observed some things that gave me pause, they were management-related and not trial manipulation.
Even If I were to accept everything AF says (I do not), NWBO still has an incredibly safe treatment that at a minimum is very helpful for a large subset of GBM subjects and dramatically affects the OS tail. In my opinion, the holy grail here has always been the combination of an approved, non-toxic immunotherapy with CIs to mute the tumor's response to the therapy. Looking at future planned trials, it seems Linda Liau believes she may have found such a candidate.
Investors should not rely on anything on this Board, including any post I make. Do your own investigation; there is no substitute for it. I'll probably rethink the wisdom of chiming in and end up deleting this post anyway.
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