NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

HyGro,

I hope you’re doing well. Thanks for the reply. At least we can agree that the emerging combo data are brilliant!

While I do believe that the first regulatory filings will be based primarily on the P3, all existing clinical data are relevant with regard to safety and efficacy.

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

https://www.uclahealth.org/cancer/researchers/spores/ucla-spore-brain-cancer/research-projects

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



https://clinicaltrials.gov/study/NCT04201873



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

“In a regulatory application, all clinical data, including data from early-stage trials, is generally relevant, even if the application primarily hinges on a Phase 3 trial. Interim data from a subsequent Phase 1 trial can provide additional insights into safety, tolerability, pharmacokinetics, and pharmacodynamics. This data can help regulatory bodies understand the full scope of the drug's effects, potential risks, and its mechanism of action. While the focus might be on Phase 3 results for efficacy and safety, the complete picture offered by all clinical trials contributes to a thorough evaluation by agencies like the FDA or MHRA.”
—ChatGPT