Replies to post #764345 on NorthWest Biotherapeutics Inc (NWBO)

[Nemesis18]

So basically, she palmed you off, stating procedural stuff that everyone already knows !

There will be no MAA for this fake cancer treatment in the UK. And I can say with confidence that NWBO no longer has any Regulatory / Clinical Trial credibility or standing, and it's Executives will be lucky not to be found criminally culpable for this despicable attempted fraud against the NHS and its most vulnerable patients & families .

[Locknload56]

Great find. It seems like NICE has more influence on the decision than I thought at this point. I thought approval would happen, then NICE would decide whether to pay for treatment. I still think it has value even if insurance doesn’t cover. Once results of the poly ic addition are known in real time results, all insurance companies will authorize payment.

[learningcurve2020]

It’s boiler plate, unfortunately. Interesting that they say “the manufacturer has confirmed” and not the regulator itself?

[DJPele]

I'm willing to bet that question will stay un-answered until the MHRA actually makes a decision.

[CaptainObvious]

Thanks!
Not earth shattering, or new info. So, we wait...

[martyDg]

A chatbot would have a better answer than these clowns.

[FeMike]

This answer is exactly what I said it would be. The same boiler plate response we've already gotten from NICE.

The answer to the other question will be almost copy and paste what we have already gotten from the MHRA. I would honestly not be shocked if it even has the same typo.

[dennisdave]

Its not meaningless. First of all, this is an official confirmation that DCVAXL is NOT dismissed off. Its incredibly likely that DCVACL will be approved otherwise, in contrary belief of the haters, NICE would not bother to be in discussion with NWBO. That is a fact. What is disappointing is that NWBO has confirmed that they are apparently still fully engaged with the MHRA. I wish that the feedback had said something like the manufacturer has confirmed that they are awaiting the decision from the MHRA.

The manufacturer has confirmed that it has submitted an application, and it is fully engaged with the Marketing Authorisation process.

NICE is in discussions with the manufacturer of DCVax-L about a potential appraisal, subject to licensing.

What I also like is that NWBO is IN discussions with NICE. That confirmation is good to hear.

[jesster64]

" NICE aims, wherever possible, to issue recommendations on new medicines close to the time of licensing by the MHRA."
" NICE is in discussions with the manufacturer of DCVax-L about a potential appraisal, subject to licensing."

Putting 2 + 2 together, NICE is in discussion with NWBO because it's close to the time of licensing by the MHRA.

[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.