NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I think we all know that the different regulators do things in different way. In the case of the FDA for higher priority approval, a PDUFA date is established after the acceptance of a BLA or NDA 6 months after its acceptance. In the UK they're trying to do things faster, it was 150 days after the application is filed, now it's been reduced to 120. A pause is built in, where after an initial review, information could have been requested and the pause wouldn't end until that information was provided, people here who seem to know indicated no such request came from the UK regulators. None of us know this to be a certainty, however the company does, if they've been asked for nothing the total decision period should remain 150 days, or even be accelerated to 120 days based on the latest guidance.

I'm not saying that we're guaranteed an approval at 150, or even 120 days will happen, however, if it doesn't it will need to be explained by the regulator to NWBO, and the company will be responsible for telling us. Personally I like our chances, but if further delays result, I have no doubt that the company can deal with it.

The UK has a pretty good history of meeting or beating their approval guidance on products they approve, that stated I believe that it could happen any day, but something almost certainly by May 22nd. By that logic, April 22nd would be the key to a 120 day decision. Forget discussion of the EDEN being involved in the UK decision, they have already approved commercial production manually, so we can get started in the UK and transition when the EDEN is approved to do so.

Gary