Replies to post #806314 on NorthWest Biotherapeutics Inc (NWBO)

[learningcurve2020]

Here’s likely how the NICE conversation goes:

You tell us how and why the vaccine seems to help certain patients then back it up with a confirmatory, and we’ll try to green light it for that subset. So long for now.

[exwannabe]

NWBO are in talks with NICE and have been for several years, on which facts there has been comment on several occasions on this board. However, NICE cannot do anything about deciding on the price etc until the NWBO's "Marketing Authorisation Application" (MAA) for DCVax has been granted by the MHRA. Then, and only then, can NICE open formal negotiations on the price of DCVax with NWBO

That is wrong.

The NICE process can start ahead of the MAA approval. The NICE website is very clear about timelines saying the company should submit the "scientific evidence" at least 6 months prior to approval. This allows NICE to evaluate, hold the meeting and form a draft opinion. At that point the process will block until MAA approval. Once approved they then would have a 3 month process of public feedback and NHS implementation (though the CDF covers the window post publishing of a favorable draft opinion).

NWBO has not yet submitted the evidence though. They announced they hired consultants to start the process over a year ago, but now have gone dark. The conversation between NICE and NWBO are simply NICE asking when the submission can be expected.