NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I'll agree that it's a crime, but at least the UK is considering it. The real crime is that all the regulators can't agree to issue EUA's and permit the EDEN to make the vaccine until they can formally approve it

The vaccine, as I understand it, has no real downside risk, no significant negative side effects. Why shouldn't EUA's be used when such outcomes are seen rather than wasting the years it takes to gain regulatory approvals.
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This has been going on as long as I know, probably from the day the FDA was formed, and prior to that in countries that predated us.

My point is that the regulators have senses, just like the rest of us, if their senses in observing a trial, speaking to both clinician and patients, and reviewing the top line data says the public should have access to this, why not issue the EUA which would permit it. If they insist, they can have their million pages plus filing, but if all use was reported in a Phase 4, I believe they could fully approve before the paperwork could be developed.

As for the production facilities, that could be a part of Phase 3 inspections and new expansive facilities could be inspected on request so when an EUA was issued, the company was prepared to provide the vaccine or other product.

Gary