The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Michelle Lim Gilson - Canaccord Genuity Corp., Research Division - Analyst
: I guess one clarifying question. So from your discussion around your EMA interaction, it sounds like the key difference between, I guess, what was
discussed with the FDA and the EMA, it was really in this, I guess, interim look that you guys I guess, second interim that you guys may take in the
first half of next year. Am I gathering this correctly or is there some other, I guess, driver behind the EMA's willingness to allow you to file, I don't
know, like greater reliance on proteinuria as a surrogate or more comfort in the eGFR data that you showed them? Or if it's a conditional, I guess,
mechanism for approval that they have as an option. And then I do have a follow-up.
Question: Michelle Lim Gilson - Canaccord Genuity Corp., Research Division - Analyst
: Got it. And on TVT-058, I know there's been a lot of interest in pegtibatinase tonight. I just -- I'm wondering if you could clarify, you seem to be
confident that either this dose or the next dose are probably the effective dose or the go-forward dose? And is that really based on blinded data
or is there some other factors? And then, I guess, would you expect -- I guess, are you seeing anything in the safety that would really prevent you
from going higher if you wanted to achieve the target product profile that you're looking for?
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JULY 29, 2021 / 8:30PM, TVTX.OQ - Q2 2021 Travere Therapeutics Inc Earnings Call
Question: Michelle Lim Gilson - Canaccord Genuity Corp., Research Division - Analyst
: Can I dig into that just a little bit more, why? I guess I'm trying to figure out if you could provide some perspective on why you're so confident that
this dose or the next dose are probably going to be the go-forward?
Question: Michelle Lim Gilson - Canaccord Genuity Corp., Research Division - Analyst
: Congrats on the quarter.
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