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
: How are you thinking about the outlook for the company with this restructuring? And how do you think investors should think about the story at
this point?
Question: Gregory Allen Harrison - BofA Securities, Research Division - Analyst
: Got it. That's helpful. And one more, if I can. Could you give us some more color on why you made the decision to shift focus to the at-home setting
and away from institutional medical setting?
Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: I just wanted to pass on by well done on this reprioritization. You made tough decisions, but I think they had to be done. And maybe first question,
and just kind of piggying back off of the (inaudible), could you outline how you see the market opportunity to make our for IGALMI now that you're
shifting the focus to the at-home setting? And how should we think about that specifically from a market opportunity point of view?
And then secondly, I think this is the most common question we're getting from investors is just updates on the timing of first the external order.
I think I heard you said by the end of the year, but any more color you can give with where you are in this process would be great.
And then on the second part of that is just timing regarding feedback from FDA. I know you've requested a meeting, but when do you expect this
to occur? And have you had any sort of interactions or feedback around this data issue?
Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: Yes. My first question was...
Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: I was just checking you heard it, right?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: So for your Breakthrough Therapy designation status, how exactly does the FDA defined acute treatment of agitation in terms of number of episodes
or instances of film usage per month? Along those lines, do you think the current pricing of $105 per film is appropriate on a strategic misstep for
the convenience of at-home use? I'm asking because of 2 factors. First, even one were to hit the annual specialty tier of roughly $10,000 per year
for pricing on a gross basis, that would translate to a patient using 100 films a year, and makers of chronic treatments of agitation enjoy significantly
higher market caps or buyout values but pricing assumptions they were much higher as well.
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: Got it. And then does your new cash runway include the potential to redo TRANQUILITY II in case the FDA says you will not be able to file on just
what you have currently?
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