NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

The Annex 1 quotes are fine nobody is disputing what GMP Grades B/C/D are used for.
What doesn’t hold up is you jumping from that to “SOW 8 completion proves Grade C rooms had to exist, be qualified, and be licensed.”

Yes: Annex 1 does say upstream prep (solution prep, sampling, dispensing) normally happens in Grade C. That part is correct.

Not correct: Pretending that “SOW 8 validation package” is an official regulatory term whose scope automatically includes every Grade-C step. It isn’t. SOW 8 is an internal Advent/NWBO label, and its exact contents are not published anywhere.

Not correct numoro dos: Claiming MHRA documentation confirms specific room layouts or licensing status. MHRA does not publish cleanroom schematics or room-by-room usage.

It’s plausible that Grade C space was involved in SOW 8, but it is not proven, and the conclusion that “Grade C rooms had to exist and be licensed” is based on assumptions about what SOW 8 covers not on Annex 1 itself.

This is what you (or your AI I dunno) are doing all the time making quantum leaps of speculation based on 25% truths