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
: First, on the 501 side, we've received some questions from investors in the actual logistics of placement of the film sublingually. We know that in
your Phase II trials, all the patients were able to place the films themselves. So could you talk about any of the experiences that you've had so far
in terms of placement of the film and the ongoing SERENITY program?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: Got it. And on the opioid withdrawal side, there are some questions around the potential for generic clonidine to be used in that setting off-label.
So could you let us know exactly how Dex might be different? We know there's some selectivity things that are going on there, so could you please
expand on that?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: Got it. And my last question on the 701 side, could you talk about what you think could be the time line on the safety run-in study for bempeg plus
avelumab because that portion of that trial is out of your hands given it's in your partners' interest to do that?
Question: Guyn Kim - BMO Capital Markets Equity Research - Analyst
: First, on 501, I just wanted to confirm that you started dosing patients in the bipolar study. ClinicalTrials.gov hasn't been updated yet. And is there
any reason that 501 would behave differently in bipolar patients? Do you think that 501 will be able to calm, let's say, a manic episode and differentiate
that between agitation?
Question: Guyn Kim - BMO Capital Markets Equity Research - Analyst
: And in case, why it will work?
Question: Guyn Kim - BMO Capital Markets Equity Research - Analyst
: Great. That's helpful. And on the financial side, could you provide how -- or how we should be thinking about operating expenses for 2020? You
have a meaningful ramp in the 501 program with multiple clinical trials. And when do you start thinking about building the commercial infrastructure
for 501?
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