NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

I agree, but I believe the additional time was needed to put licensed GMP manufacturing in place for the UK, Germany and the rest of the EU. More than sufficient DCVax-L manufacturing capacity was already available in Memphis with Cognate/CRL to cover all of North America (US and Canada).

Now, that the Advent facility has been GMP licensed, NWBio can move forward with the FDA Project Orbis program, and apply for almost simultaneous approval for DCVax-L approval in all 4 regions (US, Canada, Uk, Germany and the rest of the EU).