NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

HyGro,

Here are some relevant links in response to your repost about the trial design. The links might help to clear up some of your misunderstanding about the P3 design and why the design was particularly appropriate for a study involving GBM.

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/




The clinical data in total supporting the DCVax-L platform technology include data beyond the trial with the ECA, and the ECA included over a thousand well-matched contemporaneous patients.

The P3 data were peer reviewed by independent physicians and qualified statisticians—refer to JAMA Oncology.

Safety and efficacy data have been gathered from various clinical settings that include both external controls and placebo controls. DCVax-L has been studied as a monotherapy and in combination with other agents.

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 as the best available therapy for rGBM.

The interim PD1 combo data are brilliant, and the trial is significant for a number of reasons relating to FDA guidelines and NIH peer-reviewed grant funding.

https://clinicaltrials.gov/ct2/show/NCT04201873

In the combo trial, patients who receive DCVax-L + placebo are being compared to patients who receive DCVax-L + pembrolizumab.

The control arm is receiving DCVax-L. While DCVax-L is not the current SOC, it is highly significant and notable that DCVax-L is being permitted to fill the role of SOC as the best available therapy within this combo study for rGBM. The combo trial also follows the P3 in sequence which in itself validates the findings of the P3 study—the placebo group in the PD1 study would not be receiving DCVax-L today if the preceding P3 trial had not produced reliable evidence of efficacy.

The U.S. NIH has supported the DCVax-L platform for years, and the NIH renewed its support in 2022 to continue to fund the development of this technology and to fund research into combination therapies.

NIH-funded DCVax-L research is ongoing at UCLA today.

NIH grants are peer-reviewed and the research that NIH funds is highly scrutinized in advance of the award and also intermittently for the term of the various research projects.

https://www.bentley.edu/news/new-study-shows-nih-investment-new-drug-approvals-comparable-investment-pharmaceutical

https://www.bentley.edu/news/nih-funded-research-related-every-new-cancer-drug-approved-2010-2016

https://ashpublications.org/ashclinicalnews/news/3819/NIH-Funding-Tied-to-FDA-Approval-of-210-Drugs



https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers

https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials

https://www.uclahealth.org/news/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020

https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter

https://finance.yahoo.com/news/northwest-biotherapeutics-announces-dr-linda-140000962.html