NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Full-context dated source links are helpful. Your citation includes a tiny excerpt from 2018 guidance. In isolation, it is misleading and reflects an out-dated stance. Furthermore, there have been FDA developments since on this point. Further still, we are talking about GBM and rGBM as opposed to a less lethal disease which respond to multiple other treatment options. Crossover was for advancing/recurrent disease for which there is no treatment to extend survival.

Here is a more recent document (2022) authored by current FDA leaders:

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

Here is the full-context link for the 2018 document that you cited:

https://www.fda.gov/media/71195/download





https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847