exwannabe,
It is not true that you must submit to NICE until after you have an approval but a company might want to if they have increasing quality life years needed or desired for reimbursement which acts as a defense against potential future competitor benefit claims. That or the company might expect early reimbursement and manufacturing rates for an early method of production might not be very sustainably profitable for the company or easy for a healthcare system to absorb. Therefore, making greater availability and lower cost top priorities, the decision to approach NICE with an early manufacturing method for a reimbursement model theoretically might be delayed to allow more time for a lower cost higher volume manufacturing method to be developed for a quicker transition while quality life years continue to accumulate in the mean time. Like you said, and her own words that you quoted indicated, Linda seems to be in no hurry to get the reimbursement model nailed down except over an 12-18 month period and this sure seems tied to Flaskworks coming on board. Until Linda indicates differently, this is what appears to be going on. Interim funding from other sources needs to be made available and I believe Dr. Ashkan is working hard with lobbying for this. Best wishes.
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