Good synopsis. So it is good to know that murcidencel is on the NHS high cost medicines list for 2024-2025 with the idea that set aside funds have been allocated for an expected approval. Also good to know that an approved drug will draw wealthier self pay patients from around the world. The Specials program will also likely draw patients wanting the DC maturation/activation process applied to their cancer types experimentally especially since L has been tested in other cancer types already and completed a Phase 2 trial in ovarian cancer. Advent should be quite busy and I expect Linda to negotiate well on behalf of ALL NWBO investors with regard to any NWBO contractual agreement with the understanding that Specials income is and has been because of NWBO. Your post highlights what we all know and that is that Linda has one chance to prove all the critics wrong or she will lose a vast amount of support. She knows this and knows that investors expect a well organized presentation of what lies ahead after any approval news. Best wishes.
FeMike... it is also possible that LP meant the word "After" in the cited statement below to apply to her discussion at the ASM?
After the MAA, and the commercialization preparation, and those activities, we also need to go through the process of applying for approval for reimbursement. So in the UK, that's a process that is handled by NICE. And NICE has been absolutely wonderful to us. I cannot say enough things wonderful about NICE. They've been supportive. They've been flexible. They're standing by.....
I suggest this because in her discussion, prior to making the above statement, she goes through the list of priorities for the company... cited below is at almost the beginning of her presentation (3rd paragraph).
So what I'd like to do, is just give you a sense of looking ahead now, for the going forward 18 months or so. What are our priorities that we're gonna be focusing on? And I'm grouping them into 3 groups; our top priorities, our second priorities, and then our, as we can, as feasible, priorities. So I'll give you the 3 groupings, and I'll just, describe. So, needless to say, our top priority, our laser focus, is to complete the process, and hopefully obtain our first commercial approval in the UK, hopefully, approval of the MAA.
She follows this with addressing the MAA, then the commercial launch, then applying for reimbursement. Then she wraps that up with:
So, that for sure will be, in our grouping of top priority activities, over the, as we look forward, over the coming 18 month period, 12 months, whatever.
So for my part, I read the section you cited as her presenting the top priority group, and that working with NICE is the third priority (of five - because applying to other countries is 4th, and expanding the management team is 5th). So when she says, "After the MAA and the commercialization preparation", I STRONGLY believe she means that NICE is the third on that list, and not that they'll begin negotiating with NICE after they receive an MA.