NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

It is best to provide the full-context source link. That article is representative of the FDA’s movement toward RWE and it reflects the views of Pazdur, but you must read the whole article. I have provided the link to the article that you cited below.

This excerpt immediately follows the excerpt that you picked out. Sounds like it would apply to murcidencel and rGBM in particular:

”It is possible that formal analyses for comparative treatment effect between an investigational therapy and an external control arm would provide the primary evidence of efficacy to support a regulatory approval in oncology, particularly for a disease type with a highly predictable natural history and the precisely measurable treatment effect.”

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