NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Every key claim in your post is factually incorrect or based on assumptions that contradict MHRA rules and basic ATMP-CMC principles.
NWBO has never stated publicly that the MAA was filed on manual production. Claiming you “know” this is either speculation or implies access to material non-public information, which is not something you can cite as fact. Besides that companies have changed the intent to manufactur mid ATMP review all the time. You are being very ignorant, denying that I have provided a dozen examples.

ATMPs cannot be approved on a temporary bridge method. The commercial route must be validated before approval. NWBO’s own November PR states that Flaskworks/Grade C is central to commercial large-scale production. That automatically excludes manual as the commercial basis. A Type II variation cannot replace a non-commercial process. Variations can only modify an already-approved commercial manufacturing route. They cannot be used to convert an interim artisanal method into a commercial process.

The idea that “one GMP machine in a C-suite” is enough to justify the commercial process is wrong. ATMP commercial validation requires process validation, comparability, consistency, QC frameworks, and full Module 3 updates. Machine-level validation is not sufficient for an autologous cell therapy.
Sawston’s Grade C suite is not yet operational; the company explicitly stated construction + installation + validation still must occur. That is incompatible with the claim that a Type II variation is “well underway” or nearly complete.

If you want to accuse others of ignorance, at least start with an accurate understanding of MHRA procedures, ATMP CMC requirements, and what variations can and cannot do, all knowledge you completly lack. Nothing you wrote aligns with the regulatory framework. You are incredibly ignorant and not as smart as you think you are far from it