jesster64,
You are trying to separate the inseparable; ). NHS and their voice NICE make sure all comers know what to expect. This is why initial demand will be limited by lack of NHS reimbursement funds because there will be no initial NICE reimbursement agreement and treatment constrained to self pay, IFRs and Cancer Fund monies. I have stated how true initial demand can be throttled back by cost and more limited reimbursement avenues so that inability to produce at true full initial demand can still meet this artificially created restricted demand. Issues regarding manufacturing cost, reimbursement rate sufficiency, business profitability and true patient demand are all dealt with by transition to Flaskworks which is why the transition time frame must be timed to be as short as possible. This can only be done, according to NWBO’s own statements about starting with artisan, with completed preparations for transitioning to Flaskworks by way of post approval variation prior to MAA approval which will be based on the artisan manufacturing system.
Since true initial demand can only be calculated by assuming full NHS reimbursement for all qualifying GBM/rGBM patients and that demand can be calculated right now as greater than artisan capacity for which there are NO PLANS to expand, cost is the obvious built in unspoken factor for MAA approval consideration because of its relationship to meeting true initial demand. Best wishes.
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