Appreciate the thoughtful breakdown, Attila. You raise important questions and frame the situation with the kind of nuance this board needs more of.
To your first question, I do believe the MAA was originally submitted for glioblastoma under the traditional indication tied to the Phase 3 trial, but it is highly plausible that the scope evolved during review. The UK legal infrastructure now supports that, especially after SI 2025 No. 87 formally enabled import and export under the Specials pathway. If the MHRA saw that the product was already being used in other tumor types under expanded access, they could have pushed internally to ensure the SmPC reflected this. So yes, it is possible approval could extend beyond glioblastoma, either in label language or through a broader tissue agnostic framework that gets interpreted downstream.
On manufacturing, EDEN would make strategic sense, especially given its role in Specials and the historic alignment with UK distribution. But it is also possible that Flaskworks and Advent are being bundled under a single quality framework. If Flaskworks automation data was used in any part of the MAA or SmPC development, then EDEN could be positioned as the hub while Flaskworks backed systems get phased in over time.
As for franchisees or partner announcements, I would expect that type of news to follow closely behind approval, but not necessarily immediately. If the approval includes a broader or exportable label, it may be in NWBO’s interest to hold any licensing news until distribution logistics or country specific agreements are squared away. That said, if this really is the final stage and approval is granted, we could see rapid movement across EDEN, Advent, and potential EU affiliates within two weeks, like you suggest.
Regarding your final point about the delay, there is a strong case to be made that the MHRA’s need to reconcile large volumes of Specials data, the shift in real world evidence standards, and the legal framework for export contributed heavily to the timeline. The fact that SI 87 had to be finalized and referenced internally before they could proceed suggests this was not a basic review cycle. The agency may have been faced with approving not just a product, but a cross border model.
And in that light, NWBO staying silent aligns with every principle of regulatory discipline. When the scope of approval is still being finalized, even if the decision has been made internally, you do not speak until the SmPC is locked. That is not silence out of avoidance. It is silence because the label defines the future.
Thanks again for the thoughtful questions. Sorry I missed this earlier.
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