Replies to post #776354 on NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

Jesster I appreciate the thoughtful follow up and GoodGuy your point about the variation is a fair one but I think there is a key detail missing

The MAA was submitted in December 2023 using the manufacturing process that was fully validated at that time. Flaskworks was not yet in commercial production and the 10K clearly says the company held off on full fabrication until regulatory feedback was received. That language describes what already happened during the reporting period. It does not suggest that Flaskworks was required for approval or that anything had to be resubmitted

MHRA does not require a sponsor to withdraw or delay an application just because a newer process is coming online. If Flaskworks was part of a variation that variation would have been reviewed during the active MAA timeline. Variations allow updates to be made inside a live file. That includes manufacturing refinements or even label adjustments if they reflect system use. None of that would trigger a reset

The NICE letter confirms that MHRA review is in its final phase and that NICE is waiting on final submission materials. That only happens after quality clinical and manufacturing review are complete. Labeling is the final step. So if there was a variation it would already be evaluated and integrated

Murcidencel is now listed in the NHS High Cost Drugs List under the indication Cancer not glioblastoma. It is available through IFR designated as an ATMP and restricted to specialist centers. That reflects how the system already sees the product. It is not a one indication drug. It is a mechanism based therapy

So yes I believe the MAA was submitted for glioblastoma. But the structure of the label may have evolved during review to match how the product is already being used. That does not require a new trial or a resubmission. It just requires the system to align around what it already knows

There is no negative event in that. No delay. No hold. Just a product that was submitted and reviewed and is now reaching the end of the process as the system around it moves to scale it appropriately

[GoodGuyBill]

There’s much we don’t fully grasp until approval drops and the underlying facts come to light. I’ve laid out my reasoning—challenge, run with it, or reject it.

Consider this:

-- The MHRA’s adoption of the Decentralized Point-of-Care Manufacturing Framework uniquely aligns with NWBO's platform—no other company with a drug pending approval shares this compatibility.

-- DCVax-L’s indication was updated from glioblastoma to “cancer”, hinting at expanded therapeutic demand requiring a much larger commercial footprint.

-- The approval timeline, originally estimated at 150 days, has now stretched beyond 500. Add Linda Powers’ statement in the 10K: “The Company has been holding off on proceeding with the fabrication of the Flaskworks system until regulatory feedback is received.” That, to me, signals that feedback—expressed publicly in the form of MHRA’s framework—has likely arrived.

Am I absolutely certain? Hell no. But does this scenario hold water and seem reasonable? Hell yes.