Avid Bioservices Inc (CDMO)

[exwannabe]

North, of course I can not prove you wrong about what was said when I was not present.

I admit I am surprised. His slides never said such (they just said Fast Track allows for a rolling submission). And the only mention of 500K pages was that that is the average size of the CTD (the shared document between the 3 key regulators, something I never knew of before seeing his slides).

fromcjgaddy

I did not read any poster (including you) saying at that time the 500K pages had been submitted. I did read CP discuss it, and at that point he mentioned being surprised that the entire BLA was 500K pages, with no mention of 500K pages being already submitted.

But whatever, I was not there so anything is possible.

Yeah, the $2M PDUFA fee is nothing. Might as well spend that as long as they wasted 10M(?) or so on doing the paperwork.