NorthWest Biotherapeutics Inc (NWBO)

[hankmanhub]

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.

Can you point to any well known case where this sort of unasked for label expansion has happened in the past?