Replies to post #798063 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Doesn't pass smell test in regards to MHRA review . None of it was a prerequisite for MAA approval . This can be add on, but not holding up approval .

What I said is that adding Flaskworks as the commercial manufacturing route is already holding up the MHRA review — that’s why we’re now almost two years into waiting for a decision. I never claimed that I know it will take many more months. I’m saying the process has become a black box where normal MHRA median timelines no longer apply.

As I mentioned, why would NWBO spend $15 million on 6–9 months of temporary manual production? And manual production has almost zero chance of being accepted by NICE anyway.

Shifting the manufacturing pathway during an ATMP review is very 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