NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

HyGro,

Thanks for reosting your perspective again about the FDA and MHRA.

The DCVax-L cell-based technology has been under clinical investigation for a significant period of time, and the overall clinical data in total include three trials spanning many years. Safety and efficacy data have been gathered from trials with external controls and trials with placebo controls. The data include DCVax-L as a monotherapy and in combination with other agents.

https://www.fda.gov/media/120721/download



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

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.

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 proven its efficacy.



The NIH is the most significant player in this game—If they had any doubt about the P3, the NIH would not continue their support and the FDA would not have permitted the combo trial to commence or continue.

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

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.



Mr. Newirth is another DCVax-L survivor well surpassing 10 years following a 2012 diagnosis! Congratulations!

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

June 13, 2023 Interview:

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

https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/

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

https://www.braintumourresearch.org/stories/in-hope/in-hope-stories/kat-charles

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