NorthWest Biotherapeutics Inc (NWBO)

[meirluc]

DCVax-L has not yet been licensed may be the expression
used by MHRA to hint that while the MAA was not yet officially approved, the
CHM may already have given its approval nod. In that case, the MHRA preferred
not to use the expression "not yet approved" because they knew that the MAA was
headed for approval.

Therefore, MHRA's safest and most accurate answer was to state that DCVax-L
has not as yet been licensed since licensing only follows after official
MAA approval and that of course has not yet occurred.

I may of course be wrong and the reality may be that the CHM has not yet given
its assent for approval but in that case MHRA could have simply indicated that
DCVax-L has not received an MAA approval which obviously implies that no
license exists as yet for NICE to consider any type of reimbursement.

Answer:

DCVax-L has not yet been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in the United Kingdom. The manufacturer has confirmed that it has submitted an application, and it is fully engaged with the Marketing Authorisation process. The National Institute for Health and Care Excellence (NICE) makes recommendations for the National Health Service on whether all new licensed medicines should be routinely funded by the NHS based on an assessment of clinical and cost effectiveness. NICE aims, wherever possible, to issue recommendations on new medicines close to the time of licensing by the MHRA. The NHS is legally required to fund medicines recommended by NICE, normally within three months of the publication of final guidance. NICE is in discussions with the manufacturer of DCVax-L about a potential appraisal, subject to licensing.