Replies to post #302120 on NorthWest Biotherapeutics Inc (NWBO)

[CherryTree1]

They may be betting on this TopelRoad.

FDA’s Historical Use of “Real World Evidence”
by Neil A. Belson
In June 2017, FDA approved a new indication for a medical device without requiring any new clinical trials. This approval marked the onset of a new era in drug and medical device regulation: the systemic use of “Real World Evidence” (RWE).* FDA based its approval on records of the product’s actual patient use rather than on randomized clinical trials.

https://www.fdli.org/2018/08/update-fdas-historical-use-of-real-world-evidence/