Replies to post #671333 on NorthWest Biotherapeutics Inc (NWBO)

[XMaster2023]

When your a basher work days = calendar days! No difference.

[StonkMaster]

MHRA on the "Swift" approval process:

We would first like to address some of the misconstrued text / misunderstanding related to news article and the purposes of funding allocated to MHRA, see below: • “The Medicines and Healthcare products Regulatory Agency (MHRA) will receive £10 million extra funding over two years to maximise its use of Brexit freedoms and accelerate patient access to treatments. This will allow, from 2024, the MHRA to introduce new, swift approvals systems, speeding up access to treatments already approved by trusted international partners and ground-breaking technologies such as cancer vaccines and AI therapeutics for mental health.” Source: Chancellor unveils a Budget for growth - GOV.UK (www.gov.uk)

The term ‘swift approvals systems’ does not relate to a specific singular new procedure type, rather the term is applied in the general sense. The MHRA press release on this subject is available for your information below:

MHRA to receive £10m from HM Treasury to fast-track patient access to cutting-edge medical products - GOV.UK (www.gov.uk)

A key action of the MHRA corporate plan is to deliver predictable and reliable operational performance having defined our priority improvements for our core services to ensure swift and robust decisions on medical products, safety signals and compliance. We are currently identifying service improvements across all priority areas with robust plans for implementation and effective change management to be in place by end Q4, as outlined in our 2023-2024 business plan. The 2024/2025 business plan will include further objectives relating to operational performance. Please also note, from 1 January 2024, developers of new medicines can now submit marketing authorisation applications (MAAs) via the MHRA’s new International Recognition Procedure. We aim to review national MAAs within 210 days.

In line with the explanation above, we hold no information on updated guidance on the SWIFT Approval Process. However, we can direct you to the webpage below related to the international recognition procedure which makes up a part of the initiatives related to the funding.
https://www.gov.uk/government/publications/international-recognition-procedure/international-recognition-procedure

MHRA on an application for DCVAX-L:

We note that in FOI 24/022 we neither confirmed nor denied that an application was held for DC-Vax-L, however, it has since come to our attention that the company have made their application public knowledge on their website. Therefore, we are now in a position to confirm that an MAA is held for DC-Vax-L. However, unfortunately we cannot comment further on the status of the application. As the press release correctly mentions “The application also requests to be considered under the MHRA’s rapid 150-day review pathway, which the agency has established for new medicines for serious unmet medical needs […] the review process will be a period of intensive and extensive further work involving responding to questions and requests for further information by the regulatory authority”.
https://nwbio.com/northwest-biotherapeutics-announces-marketing-authorization-applications-submitted-uk-mhra-dcvax-l-glioblastoma/

We understand that this market authorisation application applies for this product to be used in a serious condition that is often associated with poor prognosis. However, the benefits and risks still need to be carefully weighed and considered. Please be assured that our assessment teams will endeavour to complete their reviews and assessments as soon as is reasonably possible without compromising on safety considerations.