Replies to post #670523 on NorthWest Biotherapeutics Inc (NWBO)

[Chiugray]

Biosectinvestor, Found it. Flaskworks does not have to go thru clinical trials to validate as long as comparability is demonstrated.

Your research from post 563125.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/demonstration-comparability-human-biological-products-including-therapeutic-biotechnology-derived

For manufacturing changes prior to product approval, FDA interprets the phrase, "data derived from nonclinical laboratory and clinical studies which demonstrate that the manufactured product meets prescribed standards of safety, purity, and potency," in 21 CFR 601.2(a) to include clinical data generated from a precursor product, made prior to a manufacturing change, so that the manufacturer can demonstrate that the precursor product is comparable to the manufactured product. Therefore, a manufacturer may demonstrate comparability between a product made before a manufacturing change and a product made after a manufacturing change. If a manufacturer is able, in FDA's judgement, to demonstrate comparability, FDA may permit the manufacturer to implement the changes without conducting an additional clinical trial(s) to demonstrate efficacy.