Replies to post #579378 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Jimmy,

I'd agree, you'd think that, but in reality the FDA insists on doing their own inspections. Back in 2021 when travel was restricted due to Covid-19 I know of PDUFA dates that were put off for many months because the FDA couldn't inspect production facilities in Europe. Certainly there were highly qualified people there that could have done the inspection, they probably could have done a Zoom meeting during the inspection so the FDA could speak with the European inspectors as they were doing it, but no, they waited I believe for well over a year till their people could make the inspection.

I believe the thing that's keeping prices up dramatically is the lack of trust between the regulators and drug developers, and the lack of trust between the regulators themselves. I have no qualms about the money that needs to prove a drug safe and effective for some minor disease or infirmity, but when something is targeting a deadly condition, I believe shortcuts to reduce the time to approval, or at least the issuance of an EUA, ought to be the standard. No trial should take the number of years that this trial has taken, not when the benefit is as clear as it is here.

Gary