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: Gregory Allen Harrison - BofA Securities, Research Division - Analyst
: Congratulations on the approval. To start off, what proportion of the target institutions that you've identified do you plan to meet with prior to
the launch? And how would you expect the cadence of formulary additions to unfold?
Question: Gregory Allen Harrison - BofA Securities, Research Division - Analyst
: Got it. Okay. And then one more, if I can, on the safety warnings in the label. Can you just give your thoughts on those, specifically with respect to
the QT prolongation? And maybe if you can talk about the impact you would expect commercially when thinking about the proportion of patients
who could be at risk -- higher risk there in this indication and in future indications?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: Nice to see a new treatment option for patients and all the work the company has done to make this a reality. I have a couple of questions. Just as
a follow-up on what supervision actually means, how long is the optimal duration for supervision? Could that be done remotely? And how would
that work for repeat doses? That's my first question, and then I have a second.
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: Got it. So we also noticed the label has a fairly generous starting dose for geriatric patients. Clearly, SERENITY was not a geriatric-focused program.
But what might this label language mean for your TRANQUILITY program? Is it fair to assume that safety has been derisked unless something new
comes up in older patients and all you need to do is show efficacy of the chosen doses in the TRANQUILITY program?
Question: Anita Dushyanth - Joh. Berenberg, Gossler & Co. KG, Research Division - Analyst
: Congrats on the news from me, too. Just I have one question here regarding the metrics. Would you be in a position to share some of the metrics
that you will be tracking to see performance of IGALMI at launch?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: Other than ex U.S. partnering, one of your options on nondilutive financing could be a royalty option. You have approval now. So is this something
that's on the table right now? Or would that logistically be simpler to process after you potentially add the agitation in Alzheimer's dementia
indication?
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