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: Albert Agustinus, Ph.D. - Leerink Partners LLC - Analyst
: This is Albert Agustinus on for Jonathan Chang. Thank you for taking my questions. What do you foresee will be the makeup of account types that
you are trying to penetrate for zifto launch? Are there any particular account types that you are focusing on? And also, are there any plans to include
zifto in the NCCN guidelines? Thank you.
Question: Salim Syed - Mizuho Securities Asia Ltd - Analyst
: Love the revised format of the call. Appreciate it. I guess one for us, Troy, maybe just on the new label that we got from Syndax, which includes
Torsades now in the black box. Just curious, there seems to be varying views on if this actually matters or not. What does it mean for you? What
does it mean for the space as you think about your own NPM1 launch and also as you progress here towards first line in particular, which I guess
there's a view out there that it doesn't matter because first line maybe is that you wouldn't see the Torsades as much. But curious to get your view
as the space evolves here. Thank you.
Question: Charles Yu - LifeSize Capital - Analyst
: So I guess with all of that in mind, for one, what kind of level of penetration or market share would you either expect or hope to achieve relative
to your first mover competitor in the space, at least in the near term, the relapse refractory setting? And can you also perhaps give a little bit more
color around the ongoing points of FDA regulatory engagement that seem to be continuing on as you head close to your PDUFA date? Thank you.
Question: Jason Zemansky - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Congrats on the great progress, and thank you for taking our question. Troy, I wanted to ask a follow-up regarding the commercial launch and
NPM1. But is having a differentiated label enough to overcome the second-mover advantage when you think about sort of prescriber inertia? Is it
more so that -- just I guess getting drug to patients? I mean, how do you overcome some of the hurdles here just given the timelines? Thanks.
Question: Reni Benjamin - Citizens JMP Securities LLC - Analyst
: Congrats on all the progress. Thanks for taking the questions. I guess, Troy, you had mentioned in your prepared remarks regarding the joint launch
meetings. I'd love to -- can you provide any sort of color in what goes on in these meetings, how many people, what's the split between you and
KK? Do you hit the ground running as soon as you get approval? Do you wait until next year? Just any sort of color as to how this will move forward.
Thanks.
Question: Peter Lawson - Barclays Services Corp - Analyst
: Hey guys, it's Alex, it's on for Peter. Thanks for taking our question. Just a quick one for me on what the label could look like. Is there any potential
for the monitoring requirements for differentiation syndrome to be different from other AML drugs?
Question: Peter Lawson - Barclays Services Corp - Analyst
: Yeah, or how to address it versus prior drugs. Yeah, thank you.
Question: David Dai - UBS AG - Analyst
: And I just want to come back to that, the market dynamics between you and the competitors. So Troy, I'm wondering, based on your pre-launch
work you and Kyowa Kirin have been doing, could you maybe share some of the initial feedback from physicians on how they're viewing [ziftomenib's
tolerability] versus the competitor's many inhibitors in the space, the [MPL1] space?
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