NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

dmb2, I have been of the opinion that the hold was because of ethics, or ethical considerations. Take a look at my 2 posts from 8/1/2021:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165216410 and

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165217120

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.

S_mack, I do not know if you watched this video talk by Dr. Richard Pazdur, but you should watch it. I believe it became very readily apparent that the DCVax-L RCT did not provide true “Equipoise” because the treatment group was doing so much better than the control group. It was very unethical to continue randomizing GBM patients to the control group.

Also, in my opinion, the 2 shots on goal refers to DCVax-L being evaluated and approved to treat both ndGBM and rGBM patients.

Here is the link to my message post with Dr. Pazdur’s talk:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165216410