Replies to post #401798 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

flipper44,

Yep. The ethical case for using historical controls seems to be absolutely affirmed by the German intervention some of us believe occurred. This may be a case where Dr. Linda Liau received her wish for a “way” to demonstrate the efficacy of treatment amongst the various otherwise confounding factors because of the ethical concerns of the German trial partners. So glad a German doctor was honored along side of Dr Ralph Steinman with the Nobel Prize for research on DCs and that German influence might have helped untangle the web. Best wishes.

[ATLnsider]

I agree 100% flipper44. In fact, Dr. Ricard Pazdur, Director of the FDA Oncology Center of Excellence, has said this, and this White Paper by Friends of Cancer Research (FOCR), explicitly states that an external control arm can be used, and should be used:

To augment or replace a randomized control with patients who did not receive the experimental product so that the difference between arms is a more accurate estimate of the actual treatment effect

The FOCR Working Group that authored this White Paper included members from academia, biotech and pharmaceuticals companies, and biotech data analytic companies, and 3 members directly from the FDA Oncology Center of Excellence (OCE): Michael Menefee, Pallavi Mishra-Kalyani, and Bindu Kanapuru.

This is another reason why I believe that the FDA is the lead regulatory agency that is driving the DCVax-L regulatory approvals train by using Project Orbis to accelerate DCVax-L approvals in the US, UK, Canada, Germany and the rest of the EU, and also making DCVax-L a foundational part of the new standard of care (SOC) treatment for newly diagnosed and recurrent GBM patients worldwide.

https://www.focr.org/sites/default/files/Panel-1_External_Control_Arms2019AM.pdf