NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Antihama, thanks, and thanks for finding my post I was thinking about. Here it is again.

flipper44

Member Level
Re: antihama post# 427069

Monday, January 03, 2022 3:09:33 PM

Post#
431650
of 654113
Antihama, to answer that question, you might look at the new — May 2021 — MHRA stance on biosimilars, which no longer requires preclinical and/or clinical efficacy studies in most cases. Therefore, if NWBO/Flaskworks is trying to demonstrate biocompatibility with the manual method, logic follows it is a streamlined process. Whoomp, there it is.

https://www.biopharma-reporter.com/Article/2021/05/14/UK-finalises-biosimilar-guidance-designed-to-improve-on-EMA-starting-point