Replies to post #776446 on NorthWest Biotherapeutics Inc (NWBO)

[attilathehunt]

Thank you for the thoughtful reply.

We won't know all until a decision is rendered. In the meantime, it warrants "what-ifs" to help guide us through all the possibilities. If the application was to be rejected, we would have learned that long ago, IMO.

The fudsters (those who claim they are here to protect us) are only interested in providing a narrative to prevent folks from adding and/or taking on a new position. That is perfectly clear. Their combined negative upside is most likely eating at them since they lost the easy way out. Now it is just pain and suffering for them...Their tone, arrogance and use of degrading others proves the pressure they are facing. With approval, we will see them in a total meltdown....Deservingly so!!

Much success to all the faithful!!

[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?