NorthWest Biotherapeutics Inc (NWBO)

[MalteseFalcon]

FWIW - My thoughts on MHRA MAA timeline:
Against fast approval:
It's a 1.7 mn page document so a lot to go through.
It's a biologic.
It's personalized.
Involves handling of tissue and blood.
The manufacturing is much more important than for a normal drug and they have to be happy with that (which I think they are).

For Fast Approval:
They have been treating patients for several years and if you include those from the trial and the specials program it is in the 100's.
There is an unmet need for a deadly disease.
The safety profile is excellent.
GBM has a much higher profile in the UK than in the U.S. both amongst the public and politicians (Parliamentary committee on brain cancer).
The UK wants to set itself up as a major player in the global pharmaceuticals with streamline approval process.
Medical community backing.

My guess is that the MHRA uses full 80 days to review but unless they find some real glaring errors that it gets approved then. That puts it about March 11th.

Given how wrong I've been about everything and it's NWBO I'm probably too optimistic. But I like my glasses ½ full.