Replies to post #770444 on NorthWest Biotherapeutics Inc (NWBO)

[learningcurve2020]

MHRA could also be laying the groundwork for a swift mRNA Plll and approval? Otherwise it makes no sense that MHRA would stall L’s application for years if the therapy was really showing efficacy. And, especially with Specials in place where there could’ve been a funding agreement until things get sorted out…

[sentiment_stocks]

The pledge you are quoting from the policy document is not the one I was referencing... there is no mention of a July 2025 start date in the MHRA / NICE pledge.

[dennisdave]

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has introduced the Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, set to come into effect on 23 July 2025. This framework facilitates the decentralized manufacturing of medicinal products, including advanced therapies such as autologous cell and gene therapies, at or near the point of patient care, such as hospitals or clinics.

https://www.gov.uk/government/collections/decentralised-manufacture-hub?utm_source=chatgpt.com

Decentralised manufacture hub
Information on the new regulations for decentralised manufacture, including point of care and modular manufacture, which come into effect on 23 July 2025.

https://www.dlrcgroup.com/new-uk-regulatory-framework-for-point-of-care-medicines/?utm_source=chatgpt.com

In a significant move towards promoting and enhancing healthcare innovation, the UK government is introducing a pioneering framework. Developers specifically designed the framework to facilitate the manufacturing of innovative personalised medicines near or at the point of care. These medicines are “point of care medicines”. Moreover, this world-first-of-its-kind initiative aims to streamline the manufacturing and regulatory processes.
This will therefore make it easier and more efficient for healthcare providers to produce these cutting-edge treatments to enable more efficient delivery to patients in need. The new framework will be implemented on 23rd July 2025, and further guidance from MHRA is expected in early summer.

But if you believe the MHRA is waiting until that is all implemented before reviewing the DCVAXL application, then you do you. I don't believe this to be true at all.

Im convinced the MHRA is waiting until June 30 to receive the last comments on the RWE/ECA etc as stipulated in the quoted article, which is obviously about the DCVAXL application.