Good grief....
Large scale-up doesn’t avoid regulatory reality and the point Im making it defines it.
Once NWBO stated that Flaskworks/Grade C is central to commercial production, it became the intended commercial process, and under MHRA ATMP rules that process must be reviewed before an MA can be granted. NWBO’s own PR made clear that Flaskworks is prepared for regulatory licensing, not “in development” as you keep pretending. You can claim manual covers the initial demand, but MHRA does not approve based on temporary stopgaps they approve the actual commercial manufacturing route, so that narrative is pure fantasy.
Only on this board could ‘large scale-up’ somehow mean MHRA should review the smaller process instead. Good grief....
The moment NWBO said Flaskworks is central to large scale-up, manual stopped being eligible as the commercial basis for an MA it’s that simple.
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