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: Daniel G. Wolle - JPMorgan Chase & Co, Research Division - Analyst
: Congratulation on the data. A couple of questions here. One is, do you consider the duration of NP between the 2 arms as balanced, especially
considering the standard deviation. And is that of a contributing factor to the outcome? Two, what explains the increased urine output and frequent
urination observed in the treatment arm? Is it because of an underlying disease, I don't believe we've seen that before. Or is it because of an increased
oral -- increased dose? And last, but not least, ahead, given what we know about REMITCH working in this -- in PBC with the same -- similar mechanism
of action and today's positive results, what does this for mean what we should expect as a potential outcome when that data reached out in the
second half?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: I have a few here. So how would 1 expect headache, dizziness, constipation and increased urine output to change over time with the chronic usage
of Oral KORSUVA? And asked another way, I guess, is how it need be managed in potential real-world usage of this product? And how would doctors
and patients think about the benefits of the product competing underlying NPH versus these risks?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: Got it. It's still quite early, but how long do you think a Phase III trial in NP could take in? Could you potentially get those results prior to obtaining
Phase III results in atopic dermatitis?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: And then my final question is a 2 parter. So in the event that the company decides to prioritize NP, for example, would you have enough of a safety
database to file in that indication alone because you have programs running in NDD, CKD, AD and PBC as well. And the second part, specifically,
what implications does the increased urine output adverse event in the KOMFORT trial mean for patients with nondialysis-dependent chronic
kidney disease.
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