NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

So the MHRA is saying that the balls in NWBO's court, I'm fine with that. NWBO is potentially bringing the biggest change in the history of cancer treatment out, taking the time to do it right is more important than doing it quickly.
Gary

The MHRA is not saying that at all. We don’t actually know whether the ball is in NWBO’s court right now or in the MHRA’s. It could be either. The MHRA said there is no backlog, and there is indeed none because they are reviewing the CMC expansion on the request of NWBO.

What people here keep missing is that if an ATMP review expands its CMC package (in this case Flaskworks/Eden) during an ongoing MAA review, then the standard 210-day review timelines no longer applies is out of the window. Once the manufacturing pathway shifts, the entire timeline resets into a much more flexible framework. That is exactly what is happening between the MHRA and NWBO.

Why is this so hard to understand? Shifting CMC during an ATMP review is extremely common. Examples:
Novartis CAR-T: +7 months due to CMC
Kite: +9 months
BMS (Breyanzi): +11 months
Orchard: +6–10 months
Bluebird Bio: multiple CMC slides causing multi-month pauses

If we take Ashkan’s September comment on the expected drug-review timing and then simply add the typical CMC extension, you end up roughly at: September 2025 + ~3 months ( a couple of months)+ typical CMC integration = Q2/Q3 2026.

And to finance that extra timeline NWBO needs runway and that is what the increase of A/S is for.
Its really not that complicated.