NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Exwannabe asked:

Then why has it not already been approved in the US where manufacturing was established years ago and only needed a signature on a contract?

Best answer: Dr. Pazdur stated any potential global new SOC needs a reasonable global ramp capacity.

NWBO will likely have the capacity to ramp from initial manual to automated sometime around now and again a few months from now.

To meet Dr. Pazdur’s requirement, automated would have needed to be much further along than it was in 2020, 2021 and first part of 2022.

My guess is this is the best primary explanation. Everything else is/was probably structured around that (eg. Final complete results, MAA/MA, JA)