Why is there so much interest in the pending application with NICE in the UK? Do people not understand that NICE is not a regulatory agency with the power to approve new cellular therapeutics (such therapeutics can only be approved by the European Medicines Agency using the centralized pathway, national approvals are not permitted)? In fact, NICE Is not a regulatory agency at all and can only offer advisory opinions on reimbursement to the NHS, and the NHS has the final say on what is and is not paid for by the government.
At any rate, apparently nobody has read this part of the NICE review manual:
"NICE will not publish guidance on the use of a technology for indications that have not been given regulatory approval in the UK."
Since NWBO has not applied for regulatory approval at the EMA, there is no way that NICE will recommend reimbursement in November. If NWBO was to unblind the data tomorrow, and submit to EMA promptly thereafter, it would still be a 12-15 months before an EMA decision would be forthcoming.
NICE review necessarily follows EMA approval, not the other way around. Even if there is a "hard Brexit", the obligation to approve new drugs will revert back to the MHRA who will not be any faster than EMA or FDA in their assessment.