Greg Wiesner's questions to Travere Therapeutics Inc (TVTX) leadership • Q3 2024
Question
Greg Wiesner from TD Cowen requested insight into what Travere plans to propose during its Type C meeting with the FDA for sparsentan in FSGS and what key questions the company intends to ask the agency.
Answer
SVP of Research and Development Dr. Bill Rote explained that the company will leverage discussions from the PARASOL initiative and propose a proteinuria reduction threshold, likely around the 0.7 gram/gram/day level the FDA has mentioned. The key question for the FDA will be to clarify what additional data or analyses are needed for the submission to ensure full alignment for their review.