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: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: I have a few here. So given you are paving a new path to treat acute agitation in dementia and the right scale to use is still evolving, would you be
required or is there any merit in setting up this pivotal trial that's coming up with co-primary endpoints on a couple of scales?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: And then moving on to the potential for subchronic dosing here. How soon after the 8 hour or so duration of effect that the patients in this trial
have the next episode of agitation? And was there a variable that you tracked in this trial?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: Got it. And my last question is more of a bigger picture question on interactions with the agency. Given that this division is undergoing a lot of
things with other high-profile-type products that are pending, have any of those -- the nature, the quality of the interaction has changed? And
how has this division -- or how is this division looking at data sets within dementia, given all the other stuff that's going on?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: I have a couple. So given your experience with these dose cohorts in the Phase Ib/II setting, what do you expect the pace of enrollment and
approximate duration of the pivotal trial program to be in an environment that remains quite variable due to the pandemic? That's the first one.
And second, you touched upon this briefly, but do you think there might be a regulatory requirement for retreatment studies? Or is there any merit
in -- including these studies in a pivotal program prior to submitting what might be an sNDA package for 501 for this indication?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: Sure. So the first part was, would there be any regulatory requirement for retreatment studies? And the second part of that was to kind of preempt
that requirement, do you think there's any merit in actually designing a pivotal trial that includes retreatment components in it?
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