GREY:ATBPF - Post by User
Comment by
MrMugsyon Nov 26, 2023 12:35pm
266 Views
Post# 35753452
RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:comgrats
RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:comgratsIf you want to see how chronic advances ... you're going to have to wait for the news releases. Just like me.
I would expect ATE to visit their local FDA office (hahaha) and discuss how acute/chronic move foward in the fastest possible manner. There will be some negotiations required here - I'm sure - and we could get laughed out of the FDA.
I would also expect that we will do as much as physically possible during P2 Acute ... to prove parts of chronic as well. Again ... I'm guessing. We have to wait for information but these are the questions I'd be asking of the FDA.
I would arm myself with old data, with new data (P1-acute), with DILIsym (acute) and DILIsym (chronic) and I would go to that office with the best case I can make for an OTENA-chronic plan.
Again - that's just me.
and ...
I'm fine with being wrong.
I am at peace with myself. : )