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: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: Thanks for the useful color and clarity that you've just given so far. So I guess the primary question we've been getting this morning, I think, is at
the top of people's minds is just around getting comfort around the exposure you'll see in TRANQUILITY II. And so -- you've addressed some of this
already, but how confident you're at the sort of the baseline population in real-world is going to see the 120-microgram exposure? And then how
should we think about this in terms of interpatient variability?
Another thing, I'm not sure if you could provide us the potential powering for TRANQUILITY II? And then just finally, one last thing. As we think
about future studies at this lower dose, do we consider switching to longer time points effect, et cetera?
Question: Gregory Allen Harrison - BofA Securities, Research Division - Analyst
: At this point, what determines your ability to increase the dose in Part 2 to 80 micrograms? And what's the process in general as far as making
adaptations to Part 2 of the trial?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: I have three. The first one, what percentage of patients, if any, in Part 1 of 783 were aged 65 and older? And how did IGALMI perform at the
60-microgram dose in those patients?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: And my second question actually does not involve a read-through to TRANQUILITY II, rather, it's a potential read-through from TRANQUILITY II to
at-home use. Based on your comments, we know exposure levels are different than older patients. But given TRANQUILITY II already involves a
60-microgram dose and also involves residential care facilities, would that data set be good enough to derisk at-home use of IGALMI, especially
given the burden of proof for safety in older patients is typically higher versus younger ones?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: And my last question, for now, is, given Part 2 of SERENITY does not include PEC scores, is there any precedent for a product being approved for
at-home use on safety data alone or on different endpoints?
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