Replies to post #543428 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

The recurrent GBM OS data is post hoc, data dredged with a n=64 that is not meet the requirements of a large-scale, well-controlled clinical trial.

Despite being repeated daily this is still bullshit. The SAP, the trial docs, the company and a federal court judge disagree. Not to mention the MHRA just gave explicit approval to the trial design by approving a pediatric study with the same trial design and the FDA gave implicit approval through their recently issued Final Guidance on ECAs.


Have a good one Gro!

[SkyLimit2022]

Thanks for the reply. I disagree. The survivors are real people.

A study for such a deadly disease was not expected to have such a long tail of survivors. The murcidencel (DCVax-L) P3 captured the tail and ended the trial, but there are trial participants still alive today well surpassing 10 years.

Research 2022 updates—some are GBM patients surpassing a decade or multiple decades…

https://www.hawaii.edu/news/2017/03/30/newirth-laker-for-a-day/

https://www.theguardian.com/science/2022/nov/17/im-just-carrying-on-vaccine-gives-brain-cancer-patient-years-of-extra-life

[HappyLibrarian]

Ultimately there is no viable treatment for GBM except for DCVax-L and by being active in the UK and EU and not just the USA the FDA is left without the final say.

Instead the UK is very likely to approve first and that will put a great deal of pressure on the FDA to follow suit.

[SkyLimit2022]

The CEO of Northwest Biotherapeutics has worked for the U.S. government, so I am sure that she understands how the FDA works. Her experience includes a presidential appointment to the U.S. Commerce Department many years ago. She also taught a course at the U.S. National Institutes of Health on the development and commercialization of medical products.

https://www.c-span.org/video/?c5017932/user-clip-linda-powers-testifying-congress