A partial halt is not a “halt”. That you all as longs keep adopting the short’s description of what happened is part of the problem with discussing what actually happened.
Good point Biosectinvestor… this was not a TRIAL HALT. It was actually a screening halt. No more patients could enter the screening process than those already in it.
an interim review was only intended to be a safety review, not efficacy.
Well not quite. The interim analysis intended for the summer of 2015 was to be an efficacy analysis.
You stop enrolling, given the data they had in 2013, 2014 and 2015, in my opinion, because delaying the treatment of the placebo patients is harmful to them, and creating more placebo patients creates more harm. So they could not have restarted the trial. There is no way, in that context, that the FDA or any regulatory body would allow more placebo patients to be selected.
The treatment for the placebo patients begins with standard of care, and the same is being given to the treatment patients. So it’s hard to argue, IMO, that the treatment BOTH the placebo AND TREATMENT patients were receiving was harmful. Probably most agree rad/chemo is rather harmful, but both sets of patients were receiving it. Additionally, some would argue that SOC actually has some benefit to at least the methylated patients. Yes, this is the short argument back to this claim, but it has a lot of merit, IMO. Just something to consider.
However, the regulatory agencies can not disclose the reason for that regulatory action as that would blow the trial. It would undermine the entire scientific notion of a blind trial to make any announcement whatsoever. And the company cannot know either. The doctors are not allowed to know. It cannot he explained, that kind of halt until the trial is completed.
The regulatory agency would, IMO, have to tell the company why they are halting the screening process. They can’t just come along, halt a trial, destroy the company’s market cap and possibly ability to get the trial to completion, without telling them the reason why. So I disagree with you on that point. Additionally, the company seems to be fully aware there was an issue with psPD, and that began with Dr. B remarking in a live presentation that pseudo progression can wreak havoc on immunotherapy trials. The Journal of Translational Medicine article went further and stated that pseudo-progression is a “known confounding phenomenon, and that they intend to use the latest criteria FOR THIS TRIAL to determine that. And further, they all claim to be blinded, and so Avii et al can relax knowing that they will be allowed to change the progression criteria for that reason.
Hence, why the various factual and legal circumstances appear to me to be the exact opposite of the theory presented by the shorts. And why, a bankruptcy would have been so fortunate for the hedge funds in the know...
I suspect that instead, the hedge funds were in the know as to the problem because someone on the regulatory side leaked it to them. And has that worked out very well for them so far, although as NWBO management points out, they are still here, and this trial is moving towards data lock, finally.
What is clear from the court record is that theories about a “futility” finding are not based upon any evidence, and are just suppositions stated confidently as fact.
I absolutely and completely agree with you on this point.
There is no actual indication that hyperprogression became a thing,
Well fortunately, in this trial, that has not been suggested. But it is occurring in other checkpoint inhibitor immunotherapy trials. I think you probably meant to write pseduoprugression.
that’s how people stopped taking vaccines and started heading to flat earth conferences.
Now wait a second... the earth isn’t flat?