Thanks @dalts66 and @George1972 interesting posts from you both....

Thanks @dalts66 and @George1972 interesting posts from you both. Like others, I have also been wondering when/if we pivoted from EMA to FDA.

From your posts, I'm wondering if you could point me in the right direction as to when CG mentioned that the current trial design has been closely discussed with the FDA?

I have been busy, so I might have missed this but i seem to remember that the reason for our last trial design change was because we were in a capital crunch and the prior study design was too expensive. I remember clearly that CG explained how this new trial design had the purpose of gathering more information but less certainty about registration.

I have heard that there has been some changes to the FDA making it easier for drug development but I guess I'm still wondering if it is just talk or if there is a true sense of certainty for Accelerated Approval rather than a hopeful expectation...