NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

Hey barnstormer, great question. There are really two possible scenarios when it comes to Flaskworks/EDEN and the MAA and both would be compliant with MHRA procedures:

1. Flaskworks was included in the original MAA submission (December 2023):

If Flaskworks was already used for manufacturing the clinical or validation batches referenced in the dossier, then it would’ve been part of the original Chemistry, Manufacturing, and Controls (CMC) section, no amendment or public update needed. This would be standard practice and totally within MHRA norms.

2. Flaskworks was added after submission via a variation:

If NWBO initially submitted with legacy manufacturing and then introduced Flaskworks during the review (which is common), they could’ve done so via a Type II variation or response to a regulatory request. Again, not something that typically requires public disclosure unless it changes the product profile in a way that’s considered material under SEC rules.

As for the Annual Shareholder Meetings:

• In 2022, they mentioned Flaskworks was being scaled and validated.
• In 2023, they did not say whether Flaskworks was in the MAA.
• And since then, there’s been no public confirmation of whether Flaskworks was in from the start or added later.

So either route is possible, and both are procedurally sound. Without an explicit statement from NWBO, it remains an open question, but not one that necessarily required disclosure under MHRA or SEC standards.