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: Chris Howerton - Jefferies - Analyst
: Awesome. Well, great, so I guess I should have introduced everybody Joe Oliveto, the CEO, David Bharucha, the CMO; and Lorenz Muller, the CCO
if I have it right. And so I guess, Joe, maybe you could start us off. Do you have an elevator pitch or an overview for the company? You could just
level set for us.
Question: Chris Howerton - Jefferies - Analyst
: Fantastic. I think that's really good. So I just, I guess let's start with PSVT. So I just wanted to clarify. So you have not submitted the NDA and you're
planning on doing that very soon. Is there any --
Question: Chris Howerton - Jefferies - Analyst
: Okay. I just wanted to make sure. I think I wrote it down wrong. So then I guess as you're thinking about that regulatory process, what should we
expect, like do you think that there's going to be an AdCom, do you think it will be a priority review or anything like that?
Question: Chris Howerton - Jefferies - Analyst
: Okay. Yeah, all right. I think that's a fair answer and we'll find out and I guess we could find out soon after you submit the NDA, right, like they tend
to or they can communicate at that.
Question: Chris Howerton - Jefferies - Analyst
: Awesome. Okay. All right. Well, so then, you know to the extent that you can, I guess, Lorenz, when you're planning towards the commercial like
ramp up, obviously expecting an approval, what does that process look like for you and your team right now?
Question: Chris Howerton - Jefferies - Analyst
: Okay, fantastic. So then I guess so there's, I guess, two sets of data that could be interesting to the various stakeholders here. One would be obviously
the safety and efficacy data. So David, if we were to focus on that, you know, like, what do you think are going to be some of the key features that
could drive utilization in this setting if you look at the clinical profile?
Question: Chris Howerton - Jefferies - Analyst
: Okay, good. Well, that's fantastic. I'm sorry if I cut you off.
Question: Chris Howerton - Jefferies - Analyst
: Yeah. Okay, good. All right, so very good. So then I guess I mean, you mentioned it, Joe, in terms of like the key value proposition. I have been a
real believer of this as well, is that you know, if I feel like my tachycardia resolved before, I make that decision to go to hospital that's going to be
like the most important part. So I guess if that's my view, I mean, how are you going to tap into that, Lorenz? Like how are you going to really sell
that story?
Question: Chris Howerton - Jefferies - Analyst
: Fantastic. Well, I mean, like I said, it makes a lot of sense to me. So perhaps premature, but I think I'd be interested in hearing the team's view of
like what features of a potential label do you think would be important, like, I think one of the topics I'd be interested in hearing about is things
like re-dosing, is that something that you think will be a key feature of what you expect there?
Question: Chris Howerton - Jefferies - Analyst
: Yeah, I mean, I think that makes a lot of sense in terms of I'll tell you the last two times I went to the emergency room, it took me over an
Question: Chris Howerton - Jefferies - Analyst
: Not a good feeling. Yeah, not a good experience, as you said, David, right. Yeah, okay, so then, all right I get it, you know, you got the -- well, I
actually do want to go back, one quick question, so we kind of -- I didn't mention it, but there was one other Phase 3 study that didn't hit the primary
endpoint, obviously you re-did and it was successful. I guess I'm just curious, has there been any kind of difficulty in explaining that to the physician
community or anything like that or you know what I mean?
Question: Chris Howerton - Jefferies - Analyst
: Okay. Yeah, no that's fair. I said I'm okay, very good. And so I guess to finalize the PSVT discussion as of now, what is the target set look like to the
degree you can describe it Lorenz, like how many physicians are there? And I guess to the extent you'd like to discuss it, Joe, what does it look like
to commercialize against that?
Question: Chris Howerton - Jefferies - Analyst
: Okay, right. So well, okay, so very good. And so then I guess one other aspect of that, the initial part of the launch that you're describing was
engaging with payers and making sure there's market access. Talk to us a little bit more about that. I mean, is there in the past we've discussed
things like pricing is an important feature to secure access. Is that still top of mind for strategy here?
Question: Chris Howerton - Jefferies - Analyst
: Yeah. Okay. All right, very good (multiple speakers) --
Question: Chris Howerton - Jefferies - Analyst
: I see. Well, maybe I'll just ask a dumb question just because they're worried that there'll be overutilization of high-priced items.
Question: Chris Howerton - Jefferies - Analyst
: Okay. Got it. And we want this to turn kind of.
Question: Chris Howerton - Jefferies - Analyst
: Yeah. Okay. Did you have something to add, David? No, okay. All right, so then I did say I was done, but I do want to ask one more question. How
are we on manufacturing for this? Would we be ready to go?
Question: Chris Howerton - Jefferies - Analyst
: Yeah, the key case studies are something to do --
Question: Chris Howerton - Jefferies - Analyst
: Okay, all right. Fair enough. And I think we do have a few more minutes, so let's talk about AFib to the degree we can. So I guess what would be
the key highlights of the data that you recently presented?
Question: Chris Howerton - Jefferies - Analyst
: I was going to ask. Okay, good.
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JUNE 09, 2023 / 12:30PM, MIST.OQ - Milestone Pharmaceuticals Inc at Jefferies Healthcare Conference
Question: Chris Howerton - Jefferies - Analyst
: Oh, fantastic. So then probably safe to assume that we need to see those data to really finalize any Phase 3 plans. I would say.
Question: Chris Howerton - Jefferies - Analyst
: Yeah. Okay. Well, very good. So maybe just I'll finalize, I'll kick it over to you, Joe. Anything final thoughts you want to leave with us here?
Question: Chris Howerton - Jefferies - Analyst
: Awesome. Well, thanks again for your time, gentlemen, and thanks, everybody, for joining us.
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