NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Here is a video featuring a talk by Dr. Richard Pazdur (Director of the FDA Oncology Center of Excellence), that was uploaded about 9 months ago:

https://vimeo.com/470713453

In this video Dr. Pazdur makes several important points:

(1). Around the 17:30 minute mark, Dr. Pazdur mentions the concept of “Equipoise” in the conduct of a Randomized Controlled Trial (RCT). Equipoise means a clinical trial subject may be enrolled in a randomized controlled trial (RCT) only if there is true uncertainty about which of the trial arms is most likely to benefit the patient:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC416446/

Dr. Pazdur goes on to site an example of a RCT (this example sounds a lot like the DCVax-L RCT) where there was a clear overall survival (OS) benefit advantage for patients assigned to the treatment arm compared to the control arm. In this example, the clinical trial patients requested a crossover option to the treatment drug / biologic, at the time of disease progression / recurrence. Dr. Pazdur goes on to say that this crossover option may confound endpoint analysis like OS, because patients in both arms (Treatment & Control) are receiving the same therapy, albeit at different times.

This example sounds a lot like the DCVax-L Phase III clinical trial. This tell me that the FDA has evolved on this issue, and they are onboard with how the DCVax-L RCT was designed, how it was conducted, and the revisions made to the SAP and Primary & Secondary Endpoints.

(2). Around the 28:30 minute mark, Dr. Pazdur talks about Project Orbis. He talks about the benefits of having a global standard of care (SOC) and an eventual new standard control group for future clinical trials.