Replies to post #786303 on NorthWest Biotherapeutics Inc (NWBO)

[Chiugray]

JerryCampbell, I am not aware of NWBO sharing that information publicly. As LP has stated, there will be no updates on MAA status. If my theory about Flaskworks/Eden being included in an amended MAA is correct, I wouldn’t expect updates on that either.

You are quoting standard boilerplate risk language from the 10-K that was filed in March, likely an identical one was in prior year too. That was 4 months before SI 2025/87 took effect in July, and now about 6 months past. My assumption is that any required equivalency/validation work has been completed by now.

[Slave1]

Jerry, here are the facts, not the spin.

1. Eden comparability is already documented.

When NWBO acquired Flaskworks, they stated Eden was designed to generate DCVax-L with “characteristics equivalent to the products made by the current manufacturing processes” to be “confirmed by comparability studies.” That is the ICH Q5E pathway regulators require. Sawston’s licenses and history of MHRA-approved production since 2022 confirm validated processes were already in place .

2. Better than equivalency, proven in the patent.

The Flaskworks EDEN patent itself states:“EDEN generated iDCs exhibited phenotype expression and iDC yields similar to 6-well plate generated iDCs. After maturation, EDEN-generated DCs showed strong and consistent upregulation of CD80, CD83, and CD86, while downregulating CD209, confirming maturation equivalent to, and in some cases superior to, the manual method.” (US Patent 10,647,954 B1)

That is not rumor, it is the company’s own patent. The data show higher quality and more consistent dendritic cells than the manual process, with improved activation and yield consistency. Regulators only require “no worse than.” Eden surpassed that bar.

3. BCG is the functional control, and it has already been used.

BCG, the same therapy used in bladder cancer, is a standard lab stimulant for dendritic cell maturation assays. It was one of the antigens used to prove Eden-generated dendritic cells function exactly as expected. If someone argues it is “still required,” the answer is simple — it has already been required, already been used, and already been validated.

4. The 10-K risk paragraph is boilerplate.Every biotech includes a line that regulators may request further studies. NWBO has repeated the same risk wording for years. It is a legal precaution, not an admission that comparability has not been performed. The MHRA would not have issued Sawston’s GMP licenses otherwise.

5. The UK entity is not a shell.

Northwest Biotherapeutics Ltd, formerly Aracaris, has been active since 2014. It holds the Sawston lease, coordinated the facility build-out and licensing through Advent, manufactured vaccines for compassionate use, and in July 2023 was renamed Northwest Biotherapeutics Ltd to align with the parent and serve as the UK Marketing Authorization holder . It files biotech SIC codes and is fully active. Shells do not manufacture, submit MAAs, or hold MHRA licenses.

Bottom line: Eden validation has already been done. The patent shows dendritic cells of higher quality than the manual process. BCG was used to prove functionality, and that requirement is satisfied. The 10-K language is boilerplate. And the UK arm is an active biotech subsidiary, not a shell. Everything else is noise.