Replies to post #661258 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

exwannabe,

If the trial was halted for a good reason, ie good news turned into bad as Linda stated back in 2015, (treatment patients fully enrolled and SOC/placebo left short and Fraunhofer claiming enrollment only occurred to the point statistically necessary which points to “the look” you claimed happened but NWBO remained blinded to, then regulators would have advised NWBO about how to proceed forward with their blessing without discussing the specifics as to why. NWBO would have been very careful to listen to that advice and keep quiet about it. The other issue is that Mr. Neil Woodford obviously became aware of this or something like this through Ms Katherine Wolfe’s questions that were concerning enough for Linda to question her motives which obviously led to her ouster from Ondra Partners. This also can be potentially linked to a freeze in Mr. Woodford’s ongoing funding participation, and apparently on his trading of the stock due to a confession of sorts by his reps that they had come into possession of non public information about NWBO after the issue with Ms. Wolfe arose, except for the last agreed to financing shortly after discovery of problem. The fact that he called what he found a bump in the road and part of what was to be expected is significant because history now tells us that manufacturing issues were very likely one the reasons for holding up the move forward in the approval process. The clean room purchases in 2015 were a hint, in my opinion, that an effort to prove readiness for manufacturing was being put in place.
Waiting out the long term data was also likely a part of any discussions between NWBO and regulators and doing so led to strength in rGBM data and allowed other L trial data to mature and provide ancillary data about the effectiveness of L.
I believe that what kept Mr. Neil Woodford out of NWBO also has kept out other big names connected to him. I also think that non disclosure of the reason for the hold seems likely to be tied non public information related to regulator discussions that NWBO wants to keep that way for the sake of maintaining controlling interest in the hands of current friendly investors while they are still financially vulnerable. Regulators would obviously have been interested early on in long term data and knowing that there was a way to bring personalized treatments to the masses if SOC was being considered which JAMA peer review and Dr. Keyoumars Ashkan wanting this for all of his patients makes pretty clear is likely. This in spite of anyone wanting to find fault with data or measures used in the statistical analysis plan to interpret it.
A halt for efficacy ( enrolled to the point statistically necessary as per Fraunhofer) 9 years early would have been a nightmare for everyone involved because nothing was anywhere close to being in place to prepare for a platform revolution and big money would have had a very good chance to try to capture and redirect this tech with open knowledge about it. Instead it is being prepared to get to the patients without being shelved or slow walked even more with slower roll out after manufacturing issues have been dealt with. Best wishes.

[biosectinvestor]

The reason for the partial halt, not full halt, is seems clear to me and I honestly believe it is and has been disclosed in plain sight, just not amplified as shorts might like.

I’ve explained my view many times here.

1) it had nothing to do with PFS, as the company remained blind and survival details were very good. There was no futility finding as shorts insist.

2) the problem was, while people clearly were living longer across the board, as Dr. Liau said loudly, and shorts simultaneously jumped on contradicting their own claims of failed trial, the control arm was eroded away by the very positive perception of patients and doctors that DCVax-L was creating unheard of positive results in terms of survival.

Shorts sought to turn the success into a horrible negative, as the 2014 Washington Post article explained specifically with regard to this company and AF's attacks.

So you had a great trial, phenomenal results in both the main trial and multiple side-trials which shorts also constantly either deny, or try to muddle. But the perception of success led to almost 90% of patients in the Phase 3 crossing over and it turned out that DCVax-L appears to have a very powerful effect for recurrent patients as well, who have residual tumor and also some of the interesting changes to tumors that come during treatment with the Standard of Care. Many interesting factors creating positive synergies that for some odd reason, a strange cabal of malefactors wishes to hide or destroy.

The issue with now having a placebo arm that is not fit for purpose, as a measuring stick for a trial designed to measure nGBM, is that randomizing people to be in the control arm serves no purpose. It's therefore not fit for purpose, not the entire
trial mind you, but just that arm. Hence why the FDA declared a partial halt. However, not to damage the trial or the sponsors ability to correct for something the regulator insisted on, the crossover, for ethical reasons, the REGULATOR was careful not to do anything that would suggest IT had inadvertently unblinded the trial prematurely. So they did not disclose either, which is very rare. typically if it is a safety issue or if the trial were found to be futility finding but that was clearly not the case. The regulator and sponsor clearly had something else in mind given where trends and thinking was going with regard to external control arms. Also, something shorts just hate to hear but obvious at the time.

So the clear message when the regulator is saying partial halt, is only some part of the trial was halted, but not all of it. If it were a safety issue, it would necessarily have publicized the issue and even disclosures and permissions might need to be updated. Disclosures also. None of that occurred because there was no safety issue. If it was an issue with the entire trial, it would not have been a “partial” halt.

Lastly, the trial ended short a few placebo arm patients. Viola. Placebo patients were halted…

And a regulator would do so in this case because randomizing patients to delay their treatment, especially when it appears a treatment could be substantially extending some patient’s survival times, which was clearly the case, would be deeply unethical. It would be experimentation on those particular persons for no stated purpose at the time, without their consent, since they had consented to be a placebo arm patient in a nGBM trial, or in the treatment arm. But if you know already that the placebo arm is not fit for purpose, randomizing them to not get treated asap, is unethical, and it is up to the unblinded DSMB or regulator to make that call. The sponsor is blinded and is not positioned to make such calls.

And no, there were not “crickets”, the details re the placebo arm and external placebo arm are explained over and over again in great detail.

But shorts love to be repetitive and play dumb. There is no outstanding issue. The partial halt was ended. The trial was ended. Issues with the placebo arm that caused a challenge to measurement in the trial were addressed previous to unblinding by an external and completely blinded, expertised group of top epidemiological statisticians to avoid any bias or contamination of the trial by any rational accusation of bias beyond the most superficial kinds of accusations by persons refusing to take note of the core details, to make, what are, at base, only political arguments.