NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

It all boils down to the UK Specials Program: DCVax has been available there for how many years? It is only logical that they would apply there first. NW and the MHRA have has many, many discussions about DCVax. They just dont approve a product for the Specials Program and forgot about it and just let the drug "run" with no updates or check-ins, analysis of patients treated, efficacy and related outcomes.

The UK "Specials" program is designed to allow for MDs to use an unapproved treatment for patients with "special" needs.

An unlicensed medicinal product may only be supplied in order to meet the special needs of an individual patient. An unlicensed medicinal product should not be supplied where an equivalent licensed medicinal product can meet the special needs of the patient. Responsibility for deciding whether an individual patient has “special needs” which a licensed product cannot meet should be a matter for the doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber responsible for the patient’s care. Examples of “special needs” include an intolerance or allergy to a particular ingredient, or an inability to ingest solid oral dosage forms. These examples are not exhaustive

The program is not for drugs in clinical trials for approval:

The exemption and this guidance does not apply to other unlicensed medicinal products, for example:
...
• investigational medicinal products;

There are also no rules at all about the product being supplied. The rules are about manufacturing GMP, MD responsibility, lack of advertising and such,

Although the MS holder is regulated and inspected by the MHRA, the products themselves are not independently evaluated for quality, safety and efficacy.

https://www.sps.nhs.uk/articles/understanding-unlicensed-medicines/
https://assets.publishing.service.gov.uk/media/645e19f5ad8a03000c38b3bc/The_supply_of_unlicensed_medicinal_products__special_GN14.pdf