flipper44,
Two things about your observations. One is that it sure seems like approval for artisan only should have come much sooner IF all necessary obligations for approval could be met. My GUESS is that the product release qualifications could not be met at the level needed to meet expected demand. The Q points to quality validation not being able to be time, personnel or cost effective without Flaskworks and digitization creating an exemption pathway.
This leads to the second point which is that the first GMP Flaskworks unit is to be installed next month according to Les. Will the C suites be completely installed by then? If not then that unit could likely be placed in a B suite setting allowing for approval of artisan fitting out while Flaskworks finishes up and doing ongoing comparisons between Flaskworks and artisan. Getting completely fitted out likely points to Fall validation and certification of Flaskworks production as the primary method unless installation can happen sooner. The question for me is whether or not MHRA will grant a temporary or permanent backup approval based on the artisan method and patient need before that time while final fitting out, testing and inspections are being done. If so, any earlier approval is not out of the question and is reasonable to talk about. Best wishes.