IR confirming that “the suites were validated by the MHRA” doesn’t prove what you think it proves.
Of course the B-suites were validated, they were inspected years ago under the original MIA. That simply means the manual configuration that existed at that time met GMP. It says nothing about which manufacturing pathway is actually in the commercial MAA today.
MHRA validation only covers the specific process and equipment present at the time of inspection. If the sponsor updates the commercial route mid-review (e.g., introducing Flaskworks in a Grade C suite), that new process must be evaluated separately. MHRA cannot approve an MA on the basis of a process that is no longer the one being proposed.
So IR’s statement is factual but irrelevant to the current question. It confirms past validation, not the commercial pathway now under review.
That’s why “the B-suites were validated” does not settle anything about whether Flaskworks/C-suite is now part of the active CMC package.
and btw NWBO stated multipile times they will not update where they are in the reviewnprocess so why start with you?
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