Replies to post #439281 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Biosect,

The saddest thing about this halt was the time it took for the regulators to agree how to proceed. If you looked at the German's reason for wanting all to get the vaccine, namely people living longer, it's a shame that all the regulators didn't review the data to date and stop the trial and approve the vaccine immediately.

I know, the regulators simply don't do such things, and perhaps that's the biggest problem with the regulators. They practically never risk their necks, and take really dynamic actions. It's not something I'd want them to do with a drug for a minor condition, but for a cancer that's deadly for 95% of the patients in under 5 years I believe such actions are worthy, but they're almost never taken.

I believe that it's clear that unless all the regulators are acting on concert with one another the U.K. and Europe will be first to act on approval. None of us are speaking about Canada, which may be following the U.S. lead, but I don't believe the Journal, or anything else will be held up waiting for Canada. I also wouldn't be surprised if much of the rest of the world follows the lead in the U.K. and Europe rather than waiting for the U.S. if the delay here is significant.

I know the U.S. FDA is considered the Gold Standard, but I believe that more and more people are critical of all the time and money it causes to be spent in achieving approvals. It is trying to become more dynamic, but even there it takes years to change even the simplest of regulations. When the advantage of products in trials for many years are really clear, it shouldn't take a year or more to apply for approval, or 6 months to grant it.

I suspect that if back at the time of the halt the 4 regulators had reviewed the unblinded data, they could have ended the trial right then, and approved the vaccine. Instead they spent over a year and finally agreed to the German view that all should get the vaccine up front. This also meant the company would have to modify the trial criteria, which also took time, probably more time than they thought while getting all 4 regulators to agree to each word in the change. No consideration is given to all the patients that can't have access to the vaccine because of the time that's being wasted.

Gary

[ATLnsider]

biosectinvestor, I appreciate your reply back to me. I will agree to disagree with you on this issue. All of the evidence that I have found, support the belief that the FDA initiated the halt. I have not found any evidence to support that the Germans initiated the halt.

However, I will not try to change your opinion on this matter. But, even in the transcript for the bogus case brought against NWBio, Lerner v Northwest Biotherapeutics, the U.S. District Judge, the Plaintiffs and the Defendants did not dispute this case fact: "Finally, on August 21, 2015, the FDA issued a clinical hold on further trial recruitment for DCVax–L"

https://casetext.com/case/lerner-v-nw-biotherapeutics/?PHONE_NUMBER_GROUP=P

There was no mention of the German regulators initiating a partial halt of the DCVax-L trial. I believe if the Germans had initiated the halt, this fact would have been revealed during the discovery process in this trial

The Germany PEI are the regulators for the DE (German registry), and the MHRA was the regulator for the UK (GB registry). Before Brexit (1/1/2021) The UK registry said the exact same thing (Temporarily Halted) for the trial status, when the UK was a part of the EU. Take a look at the EU clinical trial registry for the UK, it says that the UK-MHRA is the relevant regulator, but it does not mean that the UK was the RA that "Temporarily Halted" the DCvax-L trial:

https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/GB

As we all know, in the US it is up to the Sponsor / Company (NWBio) to update the clinical trial registry. But, in the EU, the regulators update the clinical trial registry. NWBio decided not to update the clinical trial registry for the partial halt, and it did not update the clinical trial registry with the revised Primary and Secondary endpoints.

I believe that Dr. Pazdur / the FDA, told us exactly why the partial halt was initiated by the FDA, and why no additional GBM patients were randomized to the DCVax-L control group.

I believe the FDA saw clear evidence that the DCVax-L trial patients who were randomized to the control group (SOC), did not live long compared to those trial patients who were randomized to the treatment group (DCVax-L). It was clear that the SOC treated patients were only living about 14 to 16 months, while the DCVax-L treated trial patients were living 28+ months, and up to 5+ years.

As a result, because there was not true clinical equipoise, it was not ethical to continue randomizing the GBM trial patients to the SOC control group.