NorthWest Biotherapeutics Inc (NWBO)

[antihama]

hyperopia, I'm having trouble understanding this

Sawston is not licensed for commercial production

I understand Sawston received MHRA approval for the manufacture of GMP cell therapy products under the UK ‘specials’ program but isn't that because they don't have a commercial product to manufacture. If DCVax-L received a MAA, wouldn't they be able to manufacture that GMP product. I'm not sure about the MHRA approval process but if this was in the US and NWBO submitted a BLA for DCVax-L, the FDA would do a pre-approval inspection prior to BLA approval for manufacture at where ever they are going to manufacture it. Is the PAI equivalent to Sawston applying for commercial production of any GMP product?