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Re: DocLee post# 750043

Tuesday, 02/18/2025 2:40:48 PM

Tuesday, February 18, 2025 2:40:48 PM

Post# of 822805
Doclee,

Just remember that murcidencel is already on NHS’s high priced medications list which indicates funds are being set aside to pay for a treatment which is highly likely to be approved. This listing is a proactive move by NHS based on what they saw up until that listing was added last year. This just goes to show that the NICE reimbursement work is not sitting in some black hole but rather undergoing some kind of dynamic change in process. This could be related to quality life years growing and helping the reimbursement model to work better for business considerations, NWBO needing to wait on getting Flaskworks into position for commercial scale use viability so the reimbursement model that L must conform to works for the business or a potential partner or something else. Most likely though this is a business model consideration delay because of the high costs involved with a personalized treatment being made available on a commercial scale.
Big pharma didn’t want to spend the time figuring this out and wrote the treatment off for this reason believing either the treatments would be unapprovable or the manufacturing process too complicated and costly to lead to a profitable enterprise. Now they recognize that they will soon be playing second fiddle and are in no hurry to acknowledge this; ).
There is also another way to interpret what Linda said because the statement you referred to did not say MAA approval but rather just MAA which is the submission for approval. Granted, approval might be the missing word being implied but since it was not stated the wording can also imply an order of things that would happen after the application was submitted. Viewing it this way points to the preparations for manufacturing that occurred after submission which includes the MIA Human designation received at Advent along with whatever else the company is working on potentially with partners or other undisclosed happenings.
The 9-12 month time line that FeMIKE points to is a realistic look at current info regarding NICE reimbursement timing. The set asides are separate from what he was focusing on but I believe should also be mentioned as a side note in his discussion as it involves NHS funding being planned for even if amounts are currently unknown. Best wishes.
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