Travere Therapeutics Inc Q3 2021 Earnings Call Transcript

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

Question: Gregory Allen Harrison - BofA Securities, Research Division - Analyst : First one is on pegtibatinase. What is the extent of the data that we could expect to see in the coming readout? And what would you consider it to be clinically meaningful there? And then assuming it is, what would be the next steps for this program if the data are supportive of moving forward?

Question: Gregory Allen Harrison - BofA Securities, Research Division - Analyst : Great. That's helpful. And then if I could sneak in one more. As far as the IgAN program, would you expect that there would be an ADCOM needed there?

Question: Michelle Lim Gilson - Canaccord Genuity Corp., Research Division - Analyst : I was wondering if you could provide a little bit more color around your pre-NDA meeting and what the FDA was most focused on. And I guess more specifically, what eGFR analyses were done and presented to the agency for IgAN. And I know we've discussed in the past that there are different ways that you can evaluate changes in the eGFR scope. And also, I think that I heard you earlier allude to priority review time lines for IgAN. And I was just curious if that was discussed during your pre-NDA meeting?

Question: Michelle Lim Gilson - Canaccord Genuity Corp., Research Division - Analyst : Okay. And then one, if I can unpack pegtibatinase as well. You're evaluating different dose levels now. And you've indicated that you may evaluate another dose level. And I'm just curious if it's -- if you expect that you'll evaluate different dose intervals at another dose level? Or if it's just, I guess, higher doses?

Question: Michelle Lim Gilson - Canaccord Genuity Corp., Research Division - Analyst : Okay. If I could just follow-up. Is there any -- I guess, are there any issues with going up in volumes here? I know it's a subcu dose. If you do evaluate a higher dose?