NorthWest Biotherapeutics Inc (NWBO)

[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.