RE:RE:RE:What is Pre-BTD Submission to the FDA?@Not, I hope they're beyond that stage also, but if they aren't.... I'm not too bothered yet. Because to me, that checkpoint could help explain why they haven't applied for official BTD yet. I think maybe a while back you & I wondered whether there could be any application ping pong with the FDA to provide clarifications etc. Maybe this pre-BTD advice process is our answer. I didn't know it existed, but that's why my timeline expectations were further out than most here. I know yours were too, if I recall correctly. I had July in my mind, to account for Q1 application (oops) plus some form of follow up request & response ping pong with the FDA which to me could mean > 60 days. I didn't get it quite right, due to being uninformed, but the timing might end up similar and for similar reasons. Sounds like the ping pong occurs prior to application instead of afterwards.