Replies to post #551617 on NorthWest Biotherapeutics Inc (NWBO)

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hyperopia, thx, I have experienced site MHRA inspections but at established mfg sites for established products.
The unique thing here is NWBO has a first product approval coming from a new mfg site, not very common. The site has been successful with clinical/specials mfg which is a large subset of commercial mfg, but not at the scale of it. So the MHRA will focus on the scaling differences, primarily Flaskworks in this case if they are seeking its approval now. I would think NWBO can use the clinical/specials GMP authorization to submit the MAA and that MHRA would then inspect for commercial readiness later prior to product approval, like FDA.
I have typically not received quality feedback from RA's when I contact them via email but I sent one to MHRA for clarification at the suggestion of another poster, who knows.

GLTA, Merry Christmas and Happy Holidays!