Thursday, March 19, 2026 9:13:46 AM
Could be but during all this time Advent brought increased amounts of apheresis capacity in house, Class C only expansion plans and there was a delay with GMP certification of a compatible Flaskworks unit for the clean rooms. There was a classification change from GBM to cancer on the high priced medicines list for IFR consideration too. The exceptional circumstances for clock off seem to have been for various reasons and I consider closed system manufacturing readiness a top priority for regulators. As explained in a post from yesterday, NICE will put pressure on pricing if manufacturing costs are reduced and create initial price issues for high cost medicines based on quality life years which is obviously why reimbursement at profitable levels could not happen until 10 year data and the increase in pricing made this feasible in the short term and Flaskworks made this possible in the longer term. MHRA wants this treatment approved but the cost has ALWAYS been an issue limiting access to patients. These issues now look like they are being or have been resolved finally… with a little help from exceptions which I have been expecting to be part of this process for quite some time ; ). Best wishes.
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