"cost is the obvious built in unspoken factor for MAA approval consideration because of its relationship to meeting true initial demand."
sorry Doc, i don't agree. Your confusing logic with common sense. They applied with artisan, we all know that. They will increase production and lower costs with Flaskworks, we all know that. Cost will keep some patients away initially, we all know that. you're making it sound more complicated than it is.
If they felt they could not meet initial demand, company would have removed submission or MHRA would have rejected.
".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."
Long winded way of saying it will be too expensive for some initially.
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