NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

ex,

“Fundamental concept” 😶



Thanks for reposting your views about the ECA and PFS again, but you are mixed up and need better sources of credible information.

You are never going to see the FDA or MHRA allow trial participants to be used as lab rats.

The crossover design was required to recruit and retain participants. Who would want to join a GBM study without crossover or remain in a placebo group after developing progressive disease without having the option of receiving an efficacious treatment?

The P3 was exemplary—clinically appropriate and compassionate.


Skip to timestamp 8:01. Dr. Liau again confirms that the crossover was mandated by the FDA.
https://edhub.ama-assn.org/jn-learning/audio-player/18738384



https://www.raps.org/news-and-articles/news-articles/2023/8/fda-finalizes-guidance-on-real-world-evidence-in-d


https://www.raps.org/News-and-Articles/News-Articles/2023/9/FDA%E2%80%99s-Califf-Expect-to-see-more-RWE-based-regulato

https://www.fda.gov/media/171667/download

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

Professor Ashkan is a careful and precise brain surgeon—listen to his words.

Skip to timestamp 13:00 of the ASCO video to hear about the ECA and the SAP.

https://www.kch.nhs.uk/news/kings-team-wins-professional-excellence-award/




If you prefer a randomized placebo design, then you’ll love the pembrolizumab PD1 blockade combo study that is ongoing at UCLA today. The study has a placebo design and the placebo participants are receiving DCVax-L.

https://clinicaltrials.gov/study/NCT04201873