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 Bronder - Cantor Fitzgerald - Analyst
: This is Daniel Bronder on for Li. First, congratulations on (inaudible) approval. It's a great achievement. Can you comment on the warning around
QTc prolongation -- and what gives you confidence that at a future time point, it won't get updated or upgraded to a box warning similar to your
competitors?
Unidentified Company Representative
Yes. Daniel, thank you for the congratulations. Mollie, would you like to take Daniel's question?
Question: Jonathan Chang - Leerink Partners LLC - Analyst
: Congrats on the approval. I might have missed it, but can you talk about the pricing of KOMZIFTI and maybe help set expectations for the early
launch?
Unidentified Company Representative
Yes. Brian, would you like to take that question?
Question: Phil Nadeu - TD Cowen - Analyst
: Let us add our congratulations on the approval. Actually, two quick questions from us. So first, on the CR/CRh rate, it looks like it's 21%, a little
different than the JCO publication. Can you give us a sense of what analysis the FDA did that was different versus what was in JCO. And then second,
just a brief follow-up.
Will you be blocking scripts? Or will the prescription services have accurate data on the launch?
Unidentified Company Representative
Bill, you snapped two questions in. Despite our admin, I only ask one. Mollie, do you want to take the question on the (inaudible)?
Question: Jason Zemansky - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Congrats on the strong label. As a follow-up to some of the previous questions, I'm trying to understand how disruptive to patients the monitoring
requirement is when there's a worry about to. I mean is it that the monitoring itself is more frequent or intense? Or is it something that just weighs
on the patient when provided with a number of options out there?
Unidentified Company Representative
Yes. Dr. Wang, do you have a perspective on that from a in terms of how you think about the two drugs now out in the marketplace and the
monitoring requirement?
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NOVEMBER 13, 2025 / 5:30PM, KURA.OQ - Kura Oncology Inc KOMZIFTI FDA Approval Call
Question: David Dai - UBS AG - Analyst
: I also want to add my congratulations on the approval. Great. So again, just to follow up on the previous question. I'm curious in terms of your
thoughts around transplantation. -- maybe this is a question for Dr. Wang. Do you see sufficient evidence around these NPM1 patients potentially
get to transplantation after treatment and also get into maintenance therapy with -- on zifto?
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