NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

ATLnsider:Corollary question: Could it be that NWBO management wanted to see today's FDA paper on external controls
(https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext#%20)
published before the publication of the DC VAX L phase 3 trial's scientific paper ?


ATLnsider Wednesday, 01/19/22 10:11:03 PM
Re: ae kusterer post# 436773 0
Post #
436826
of 436838
Yes, in fact, I believe that because of the crossover issue, and the fact that it was unethical (lack of clinical equipoise) to continue randomizing GBM patients to the control group, it was Dr. Pazdur and the FDA who suggested to Dr. Linda Liau and to NWBio that they use external control arms (ECAs) in the revised SAP for the DCVax-L Phase III trial, in addition to the randomized control group in the trial.

I also believe that the FDA was the first regulatory authority to give NWBio buy-in on the new SAP that revised the Primary endpoint to compare the DCVax-L trial treatment group OS, to the OS of ECAs. I believe NWBio was waiting for the UK, and Germany (EMA) to buy-in to the revised SAP and the use of ECAs.

NWBio announced data-lock on October 5, 2020 which indicated that NWBio had finally gotten buy-in to the use ECAs from all 4 regulatory authorities. Then on October 8, 2020 (3 days later) we discovered that the clinical trial registry in the EU (for the UK) had been updated to show the revised Primary and Secondary endpoints.



ae kusterer Wednesday, 01/19/22 06:06:04 PM
Re: None 0
Post #
436773
of 436841
With Padzur as a co-author on this paper, the use external controls appears accepted by the FDA. But haven't we know this for awhile?


https://www.fda.gov/about-fda/fda-organization/richard-pazdur

https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext#%20