I would think NW can submit appraisal based on Flaskworks right after approval and if they have to use artisan methods and sell at discount till EDEN/Flaskworks is up and validated , it is still better than delaying approval by 6-12 months.
yes, NWBO can file for a variation after approval. It will be a Type 2 variation (major), I confirmed this with the MHRA (Alex). I thought it might be a Type IA, but it not. Any major change would be a Type 2 variation. Its usually pretty quick, 30 days with any RFIs adding to clock off. Average time for a Type 2 approval is 90 days.