Replies to post #698591 on NorthWest Biotherapeutics Inc (NWBO)

[Margin Buu]

The MAA was complete and submitted.

Who seems to be waiting for paper work? For what? The company is waiting for a response from the MHRA.

[kabunushi]

You wrote MHRA must coordinate with NICE. Just to be clear, I think you made that up and it's wrong. NICE indeed has to evaluate before the treatment can be marketed, however, I think MHRA is independent and comes first. Per CancerResearchUK, the following explanation of the UK authorization process states that NICE evaluation follows MHRA evaluation. This clearly implies that MHRA evaluation is not gated by NICE evaluation. NICE will try to make their evaluation contemporaneous with the MHRA approval to the extent that they can, but as I read it, NICE evaluation can come later but MHRA approval is not dependent on NICE evaluation. Correct me if I'm wrong.

How cancer medicines are licensed in the UK

After a drug is licensed
After getting a licence, other organisations also need to approve the drugs. Only then can doctors prescribe them.

These organisations decide which drugs work well and are cost effective to use. They are:

The National Institute for Health and Care Excellence (NICE) in England
The Scottish Medicines Consortium (SMC) in Scotland
The All Wales Medicine Strategy Group (AWMSG) in Wales

After a drug is licensed
After getting a licence, other organisations also need to approve the drugs. Only then can doctors prescribe them.

These organisations decide which drugs work well and are cost effective to use. They are:

The National Institute for Health and Care Excellence (NICE) in England
The Scottish Medicines Consortium (SMC) in Scotland
The All Wales Medicine Strategy Group (AWMSG) in Wales