Replies to post #232486 on NorthWest Biotherapeutics Inc (NWBO)

[Extremist223]

lol

that’s how people stopped taking vaccines and started heading to flat earth conferences.

[exwannabe]

First, it is a clinical hold (at least in the US). Not a halt or partial halt. The FDA issued hold was only partial, that is true. But still a hold. Straight from NWBO:

NW Bio Announces Lifting of Clinical Hold on DCVax®-L Phase III Trial By FDA; Progression-Free Survival Events Reached; Overall Survival Events Not Yet Reached

Back to the meat of the issue.

Most all agree it was not a safety issue (though longfellow has suggested the possibility that the actual placebo caused damage as it is active).

On the "damaged by not getting the drug" theory, that is efficacy. But the FDA makes clear that they do not make the call on early efficacy terminations, the sponsor does.

Further, how would the FDA even know if the DSMB had not performed an efficacy IA? They do not generally peek into trials unless they are alerted to a safety issue. The rare exceptions they mention would not apply.

Your trial records do not discus the matter, they address earlier issues such as the '13/'14 IA that was expected to have an efficacy review but was nixed.

There is no proof of the futility theory, that is true. But we do have these facts:
. A still unexplained FDA Clinical Hold
. An IA gone MIA
. Trial running years past the primary and secondary endpoints
. Changing the trial SAP, including redefining the primary endpoint

That sounds a hell of a lot like something when wrong, not right.

Feel free to wait on "proof" one way or the other.

[AVII77]

There is absolutely no indication, I’ve been going through various releases, presentations and court matters, that there was a futility finding. In fact, an interim review was only intended to be a safety review, not efficacy.

Demonstrably false

Guess you missed this in your deep dive due diligence.

[sukus]

Thumbs up!

[sentiment_stocks]

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?


:)