RE:Will it be different this year? The timelines have been set. Pre-BTD went in sometime on the first week of December. Assuming they max the respsonse times out to 60 days for both Pre-BTD and BTD submittal response, were looking late March, early April for designation.
They've been pretty forthcoming with the details and timelines associated with this submittal, I would expect that would accompanied by a high degree of confidence in the FDA response.
I might try to ping Banana on X and see if TLT is on his radar. He loves a good biotech!