NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

I do not believe the FDA did the partial halt, but the rules are, in a global trial if any of the regulators do a halt, the FDA also adheres to that halt. I expect all the regulators behave similarly.

The FDA is far more transparent. I believe some of the issues related to this trial involve complex issues that happen when you have conflicting policies and rules involving a trial in multiple countries under multiple regulators. Inevitably there can often be some issue that arises that is substantially different in one country than another and I personally believe, and have since my first post in this board, which was deleted, said that I believe the Germans are particularly uncomfortable with anything they perceive as unethical human experimentation. I believe they felt the placebo arm was getting clearly inferior care and felt that it was an ethical concern to maintain the placebo. The partial halt happened not long after the trial started in Germany and also not long after they got the Hospital Exemption, which is an extremely thorough process of review.

I do not think the FDA had any issues with the placebo arm, I believe they insisted on the placebo. So that is the jurisdictional difference I am suggesting could be one of the reasons for the complexity here and also for the mystery.

So while the FDA is the primary regulator, they can’t tell a regulator in another country not to do what they think is ethical, and the regulations require that a trial that is halted in one country, is also halted in US. In this case it it was a “partial” halt and only the final count of the placebo patients was affected. I believe the company indicated that they were not told the reason, which together with no public discussion of any safety failings or stopping of the deliveries of DCVax, including for compassionate use, or for patients outside of the trial, just lots of indicators to me suggest it was not at all related to DCVax itself as a “product”. Nor is there a suggestion by the facts that it was dictated by any worries about the drawing of blood to get the dendritic cells. There is absolutely nothing to suggest that treated patients were in any danger or risk for their safety.

So in my opinion, it was for ethics, but not a determination of efficacy because the trial’s entire premise was based on having a placebo, as per the original FDA insistence. Again, jurisdictional differences in my opinion.

So you get a kind of complicated muddle out of that and I think everyone likely knows this looks to be a really wonderful potential new treatment, IMHO, and I believe that is another reason why it seems to me the FDA is bending over backwards to do what it can to help get this over the finish line including addressing the external control guidance. I just think they go slow when reforming themselves.

Everything in terms of regulation in a global endeavor like this is it going to be “clear”, because that is the nature of multilateral cooperation, that there is often ambiguity. Regulators learn to work together to address these things often, and sometimes they are individually stubborn. The FDA seems to me to be doing its best to accommodate, but they are just very slow with this kind of change, particularly so in a pandemic.’

https://www.thestreet.com/.amp/investing/stocks/northwest-bio-forced-to-temporarily-halt-study-of-brain-tumor-vaccine-13263780

“ Investors picked up on the temporary halt of the DCVax-L study before trading opened Friday from a notice posted on the European Union Clinical Trials Register web site. Northwest Bio didn't acknowledge the halt publicly until late Friday afternoon, but by then, the damage was done. Northwest Bio shares closed Friday down 22% to $6.96.”

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

“ Summary
EudraCT Number: 2011-001977-13
Sponsor's Protocol Code Number: 020221
National Competent Authority: Germany - PEI
Clinical Trial Type: EEA CTA
Trial Status: Temporarily Halted
Date on which this record was first entered in the EudraCT database: 2013-02-11”