NorthWest Biotherapeutics Inc (NWBO)

[newman2021]

MI D, thanks for your DD. I too think one or ORBIS kind of RA approval is happening behind the curtains. There is no question about the expected overwhelming efficacy on the new primary nGBM and secondary rGBM endpoints, but there are shorts then fuding on whether an RA would approve. Instead these shorts should tell the world how to design a GBM trial in the future. Do they allow placebo? Will they let the placebo crossover? Is PFS their endpoint? If so, how would they handle pseudoprogression in the trial?

The latest trial in rGBM is authorized by the very same FDA to have External Controls meaning no placebo involved. How about that? Read the last question in this link.

https://www.outsourcing-pharma.com/Article/2021/07/08/Medicenna-takes-on-deadly-brain-cancer-in-clinical-trial