RE:RE:RE:RE:One detail that I just noticedI really hope that they are smart to use consulting firms to help on this. There are firms staffed by ex-FDA staff who used to be on the other side of the table reading the BTD applicaton. If TLT is using that kind of advice then that means they will/have submitted when they have been told it will most likey be successful. They also advise on wording and key data to highlight.
Plus you get a free meeting with FDA to discuss if the application is ready for BTD. Two levels of input to optimize success.