Replies to post #789106 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

exwannabe,

One more rare occasion when I am in agreement with your assessment! L is not a point of service product at this time even with Eden in place. At some future date it might well be. The reasons you outlined are valid enough for declaring that L is not a point of service treatment at this time. If NWBO can find a way to digitize the role of qualified person and a few other aspects then there will be a decent chance for point of service. Best wishes.

[The Danish Dude]

Well, ex. If you continue a decade more, who knows?! At one point you might actually state something factually 👍



What SI 2025/87 actually does

Creates the world’s first statutory framework for decentralised/PoC manufacture with a Control Site (hub) that owns the licence and quality system for a network of hospital spokes, documented in a Decentralised Manufacturing Master File (DMMF). Onboarding new spokes occurs by updating that master file.

• How NWBO maps to that law

Sawston functions as the hub under Advent’s licences; spokes can be qualified hospital cleanrooms that run standardised steps under the hub’s QMS and release authority. This is a hub-and-spoke model, not cloning a full factory at each hospital.

• Role of Flaskworks EDEN

EDEN is a closed, automated system designed so production can move from Grade B to Grade C rooms, expanding capacity at materially lower facility cost and simpler operations - exactly the economics needed for safe decentralisation.

• Why PoC matters for DCVax-L

Autologous products depend on a patient’s tumour lysate + leukopak. Shortening “vein-to-vein” logistics reduces cold-chain risk and chain-of-identity complexity; a hub can still centralise testing/release while spokes run the automated step locally.

• What MHRA already signalled in 2024
A “de-risking cascade”:

1. Company concluded EDEN-made product is “substantially comparable.”

2. GMP licence granted for the automated process at Sawston.

3. MAA validated - the file, including CMC/comparability, accepted for full review.
These steps indicate the manufacturing approach cleared key gates.

• What NWBO actually says about scale-up
Filings describe:

Advent running Sawston; large cryostorage; release-testing streamlining; engineering for Grade C labs where EDEN may be deployed at lower cost and higher throughput. This is central to the company’s commercial plan.

• “Franchise” meaning, clarified

“Franchise” in NWBO materials means technology/IP leadership in dendritic-cell immunotherapy (platform + in-licensed portfolios), not retail-style franchising. (ASM remarks; 10-K IP section.)

Net: The law (SI 2025/87) empowers a hub-and-spoke PoC network; EDEN’s closed automation is built to make it economical and controllable in Grade C rooms; MHRA’s 2024 GMP licence and MAA validation show the model is already accepted for full review.

The board-post insinuations invert these facts.



How Linda Powers Testimony Shaped MHRA and NICE Reform

Flaskworks Eden 2.0: Building a Decentralized Point-Of-Care Network

[skitahoe]

You say it would be expensive, EX, why? If the staff at the hospital or research institution were trained and were doing all the work, they'd be paid from the portion of the money they'd be paid for the DCVax-L. Otherwise the only expense would be the EDEN, which would be leased to them, and the disposable cassette, which is part of the cost of making every batch. As I see it, the cost would be lower than making it in Sawston, but of course they'd be paid for making it, but until all costs are resolved it's hard to know how much more, or less that will be than operating Sawston.

I see spoke operations as being both very economical, and saving the company major expense in having to greatly enlarge the size of the hubs in a hub and spoke organization.

Gary