NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

brazen22,

Yes, I read that one. In my view, it is very similar to your other posted citations that all make the case for phase 4 investigation. Data should be gathered in support of all newly commercialized drugs, and I think that any physician would support further data collection — phase 4 can also lead to further development and broader application across oncology or perhaps beyond oncology.

The reason why we cannot expect a placebo design is because GBM is somewhat unique, and a placebo design would require trial physicians to treat participants without clinically appropriate compassion.

The UCLA combo study is using a placebo design because the placebo participants are receiving a treatment that is efficacious for rGBM.

https://www.jci.org/articles/view/169314

https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers