NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

I think the reason this is taking so long is that MHRA is positioning DCVax-L as the pilot case for a new UK-wide regulatory framework for autologous dendritic-cell vaccines basically a platform-level approval, not just a drug decision.

I’ve been scolded here before for even hinting at timelines, so I’ll be careful but I honestly can’t see this drifting into December. The MHRA has repeatedly stated they’re proud of having cleared their ATMP backlog, and with their next “Where We Stand” update on ATMPs expected in late November, I doubt they want to walk into that meeting still holding an unresolved high-profile case like DCVax-L.

Just my view but optics matter, and admitting another ATMP backlog would undermine their own narrative. IMO.