Farzin's questions to Travere Therapeutics Inc (TVTX) leadership • Q3 2024
Question
Farzin, on behalf of Maurie Raycroft at Jefferies, asked if data from the open-label extension would be included in the FSGS Type C meeting package and whether pre-specified analyses are considered sufficient or if more post-hoc work is needed.
Answer
SVP of Research and Development Dr. Bill Rote confirmed that open-label extension data from both the DUET and DUPLEX studies will be included. He stated they will present existing pre-specified analyses and will work with the FDA to align on any additional analyses required for the submission, rather than conducting extensive new post-hoc analyses beforehand.