Replies to post #670501 on NorthWest Biotherapeutics Inc (NWBO)

[drugrunner]

Ex stayed at a holiday inn express last night

Thinks he is an expert on everything DCVAX

[biosectinvestor]

They have validated measures for viability of cells and potency already established, which they have talked about before. There are established quality measures and whether a person or a “machine” makes it, it is literslly (not comparatively) the same exact processes. Those measures are and will be valid for the same product, in exactly the same manner. Your verbal effort to manufacture differences doesn’t make it actually so.

Don’t be flatworld level ridiculous in a 3 dimensional world. See the forest for the trees and at least pretend to be rational.

[flipper44]

Flashback:

flipper44

Member Level
Re: post# 427069
Monday, 01/03/2022 3:09:33 PM

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