Travere Therapeutics Inc to Discuss Regulatory Update on Sparsentan Development Program for Focal Segmental Glomerulosclerosis Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Guyn Kim - BMO Capital Markets Equity Research - Analyst : It seems that you suggest -- or you suggest that the FDA pushback was around the initial reduction in eGFR caused by sparsentan's mechanism. Could you confirm that the irbesartan arm also saw the same effect on eGFR? And if you could let us know if there was a rebound in eGFR in the early enrolled patients.

Question: Guyn Kim - BMO Capital Markets Equity Research - Analyst : Okay. And do you think you'll be able to provide an update on the data before potentially refiling with the FDA in the first half of '22?

Question: Michelle Lim Gilson - Canaccord Genuity Corp., Research Division - Analyst : I just wanted to clarify, I guess the FDA -- that the FDA isn't concerned that the data is predictive of the study failing the confirmatory to your endpoint, that, that's not their concern. They just want, I guess, more clarity and additional data to confirm the benefit that you're seeing.

Question: Michelle Lim Gilson - Canaccord Genuity Corp., Research Division - Analyst : Okay. And then just in terms of what you're looking at for PROTECT, you're looking -- you're going to be looking at the eGFR data for all 380 patients in that study, not just the 280 that are included in the interim proteinuria analysis.

Question: Michelle Lim Gilson - Canaccord Genuity Corp., Research Division - Analyst : Okay. And in terms of IgA nephropathy, there's a better established link between proteinuria and eGFR. Is there -- do you think that, that will play a role in terms of the viability of the PROTECT data or based on your interim analysis? And I guess I'm wondering if the FPRE endpoint itself and its, I guess, validity in terms of predicting eGFR preservation is a key concern and if that could be, I guess, ameliorated in terms of the IgA nephropathy study just based on, I guess, the robustness?