I have since considered the input of NICE at influencing how NWBO approaches approvals. My guess is that demand is expected to be very significant and grow exponentially. NICE is now able to get reimbursement decisions in line with approval decisions in some cases and I expect an early decision by them would be related to Edens manufacturing reimbursement rate. They play hardball when it comes to pricing and I don’t buy the argument that they would be willing to fork out much bigger money for the artisan method only to have Edens producing almost all of the vaccines at a much lower cost soon after. So yes, I believe manufacturing is at the heart of the delay issue and that the artisan method was part of NWBO original plans that Covid delays and expanded label to rGBM and likely lower grade gliomas changed. Tissue agnostic designation is likely to be added not long after initial approval because of extensive proteomics analysis already done. I’m sure this has entered the picture too for NICE and perhaps their attitude towards reimbursement rate as initially these treatments will all be add on cost to SOC. I’ll bet NICE will work hard to change SOC too so that only treatments needed and working get reimbursed. Best wishes.
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