NorthWest Biotherapeutics Inc (NWBO)

[MysticDomain682]

Dear Jimmy,

Thank you for contacting the National Institute for Health an Care Excellence (NICE) regarding our developing guidance on DCVax-L for treating glioblastoma. Your enquiry has been passed to the enquiry handling team as we deal with queries about how we work and our guidance and advice products. Our direct email address is [e-mail].
At NICE we produce a range of different types of guidance. The topic that you refer to (DCVax-L for treating glioblastoma - ID836) is technology appraisal guidance, this type of guidance makes recommendations on whether all new medicines, including cancer medicines, should be routinely funded by the NHS based on an assessment of their costs and benefits. Our appraisals are submission led, for the appraisal to proceed we rely on an evidence submission from the company (typically the manufacturer of the product), to demonstrate the clinical and cost effectiveness of their product.
NICE is not responsible for issuing the licence for medicines, this is the role of the regulatory body, the Medicines & Healthcare products Regulatory Agency (MHRA). They issue the marketing authorisation (also known as the licence) for Great Britain and have ongoing responsibility for ensuring medicines meet the relevant safety standards. We aim to align our processes so that we publish final guidance around the time that the treatment is awarded its marketing authorisation, this is because we can only publish final guidance on licensed treatments.
I can confirm that we continue to liaise with the company, Northwest Biotherapeutics, regarding an appraisal of DCVax-L for treating glioblastoma. The company has not yet been able to provide an evidence submission to NICE but has advised it is still fully occupied and engaged in the marketing authorisation application process with the MHRA.
The last update on this subject from the company was received by colleagues in April 2025. Colleagues in our medicines evaluation team last emailed the company in mid-December 2025 asking for a further update. They have not yet received a response but if no reply is received, they will contact the company again in February 2026, in line with NICE’s usual processes for this situation.
I do hope this information is helpful.
Kind regards

Katy



Katy

Communications Executive

National Institute for Health and Care Excellence

3rd floor | 3 Piccadilly Place | Manchester M1 3BN | United Kingdom
Web: http://nice.org.uk

My current working hours are 8am – 4pm Monday to Friday (term time) and 7am -3pm school holidays.







From: James Malek <[e-mail]>
Sent: 30 December 2025 22:48
To: Scheduling <[e-mail]>
Subject: inquiry ID836




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Hello:) I am reaching out about the product ID 836 DcVax Northwestern Biotherapeutics' item being overseen by NICE for the medically intended effectiveness, and designating an appropriate cost/price. I see that there has not been an update for what seems to be a far more than normal extended period of time, with respect, when comparing, NICE approval with similar-(new advancements) in the science of medicine. However, I have seen other products, by various developers, released to market with less data driven efficacy, and involve scientific observation and notations of having negative side affects in trial and after trial documentation.



Could you inform me as to what is being required by the above named company to make this product accessible to all persons in need of its specific medicinal properties.



Thank you for your time in reviewing my email. I look forward to receiving a response at your earliest convenience.



Sincerely,

Jimmy

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