RE:BTD and pre-BTD overview According to the details from 8 years ago, pre-BTD seems to be a 15 minute phone call with an expert FDA panel with no more than 2 pages of info. If you look at the bullet points, TLT should have already covered all of those under the fast track umbrella. Maybe they still want companies to follow this process to weed out incompleteness, or validate that the prior assertions made are still true before committing time from senior FDA managers to the BTD review? Hoping for a home run instead of a foul ball.