then AA could happen any time. Huge difference. And AA can be based on '..clinical data.' not just a surrogate.
Yup, that's the point I'm confused on and it is definitely a huge difference.
They said they wouldn't even file NDA until first HALF of 2014 which means they don't think they will get it in within the first quarter, or they would have said that. Therefore AA can't happen until 3Q2014 unless they get the NDA in faster.
I don't think they can or will file until the manufacturing of E. in quantity is worked out.
It would be rather embarrassing to have to "ration" E. to the public.