NorthWest Biotherapeutics Inc (NWBO)

[The Danish Dude]

Realistic MHRA MAA approval timetable:

From submission to acceptance < 14 days



From acceptance to approval < 80 days



Fast track STILL an option.

MHRA knows in details everything about DCVax-L.

PIM designation, compassionate use for a decade, approved PIP plan and a whole CDMO build up around manufactoring DCVax-L.

Not forgetting MHRA have instigated rules, regulation and extra funding during 100 days, especially targeting getting cancer vaccines more quickly to patients. Cancer vaccines of which only one is about to be approved in said timeline.

MHRA have all incentives to get DCVax-L approved quickly, which is why we will see it approved in the UK well before christmas.