A key point to keep in mind with the Nov 20 announcement is that the new Grade C manufacturing suite at Sawston represents the next phase of scale-up, not a prerequisite for approval. The commercial MAA now under MHRA review was submitted on the existing, fully licensed Grade B manufacturing process, which has already been inspected, validated, and used for clinical supply, Specials, and the full sequence of clean-room implementation activities described in the filings. That’s the process MHRA is evaluating for initial approval.
Are you still thinking mid-2026 for MHRA approval?
It seems clear to me approval can happen any day now using Artisan method.