Replies to post #544729 on NorthWest Biotherapeutics Inc (NWBO)

[dr_lowenstein]

oh, ok, provide examples where that was the case

[OncoJock]

Agree. Now here's some text from what appears to be a reliable source regarding the drug approval process in the UK.

Source: https://www.mstrust.org.uk/a-z/drug-approval-process

text pasted from this source:

Licensing

The licence (or marketing authorisation) for a new drug for multiple sclerosis is granted by a regulatory authority. The regulatory authority reviews the clinical research to check that the drug is effective, safe and meets manufacturing quality standards. If they are satisfied, a marketing authorisation or licence is issued. This allows the product to be sold by the licence holder in the regions covered by the regulatory authority.

From January 1st, 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) carries out licensing for new medicines in England, Scotland and Wales.

more text from the same source:

NHS appraisal

Once a new medicine has been licensed, it needs to be appraised by the bodies that decide whether it is a cost effective treatment to provide on the NHS. The NHS is legally obliged to fund medicines recommended by these bodies. The reverse also holds true - if a new drug is not approved, then local health authorities are not required to provide funding for it.

The bodies that appraise new drugs are:

England - National Institute for Health & Care Excellence (NICE)
Wales - NICE / All Wales Medicines Strategy Group (AWMSG)
Scotland - Scottish Medicines Consortium (SMC)
Northern Ireland - Department of Health (DoH)

My take:

So . . . it appears that before DCVax-L can become widely available for sale in the UK (producing actual sales revenue for NWBO), the following steps must happen:
1) manufacturing authorization for the factory, from the MHRA
2) marketing authorization for the product, also from the MHRA
3) cost effectiveness endorsement of the product by at least the NICE (for England) and possibly also AWMSG (for Wales), SMC (for Scotland) and the DoH (for Northern Ireland).

Would you agree?