Ken Marshall: Yes, I’ll take that, the second part of that question. And looking at it from a weight-base standpoint rather as will probably be labeled 90% of the market uses the adult dose. So it’s this overwhelming majority is in the 0.3%. Usually up to about age five or six, you’re using the junior dose, which represents about 10% of the opportunity.
François Brisebois: Okay great. Thank you very much.
Operator: One moment for our next question. And our next question comes from the line of Andreas Argyrides with Wedbush Securities. Your line is open.
Unidentified Analyst: Good morning. This is Caroline on for Andreas, and thank you for taking our questions. We just have a couple. So just curious what the gating factor is to be getting the pivotal PK study in this quarter? And then on the pediatric study when do you plan to start the process of aligning with the FDA on the design? Is it still reasonable to assume that the trial would be complete by the middle of next year? And then I have a follow-up.
Dan Barber: Sure, yes. So those are pretty straightforward, Caroline. So Carl, I’ll address these for Caroline. There is no gating factor for the pivotal PK study starting in Q4. It’s just the process of getting it up and running, right? So we are — it’s all operational pieces that we’re focused on. And in terms of the pediatric study, we have been in dialogue with the FDA and continue to be in dialogue with the FDA on the final design of that study. So it’s not that we have not approached them and it’s going to be a new discussion. So we feel comfortable that, especially as we get data from the adult study that the pediatric study will be in a good place to begin. In terms of the timing, obviously, conducting a pediatric study is always — had a little more complication than an adult.
But given the size that we believe this study will be, and the scope, we do not believe it is an expensive or long study to run. So yes, we do believe that the timing we’ve laid out is reasonable.
Unidentified Analyst: Okay. Great. And then, I have just have one additional question on Libervant. In the 12-year-old and older population, can you just provide any additional insight into the work you’re doing to remove the exclusivity block and bring this product to market?
Dan Barber: Sure. Yes. I would love to give you and the rest of the community a lot of insight into this area, but it is not an area that at this time we can share a lot. So I would think of Libervant this way in terms of how it fits into our company, I do believe Libervant is a potential important catalyst in 2024, call it kind of the upside wildcard. The two-to-five-year-old application, we feel good about. We think there’s a real need in that space and we think it’s a sizable enough opportunity to matter. So we are very focused on that at this point, especially with the near-term target action date ahead of us, but we have not lost sight of the 12 and up application as well. And we continue to believe that there are avenues to bringing our application to market ahead of orphan drug exclusivity exploration for the competing products.
Unidentified Analyst: Okay great. Thank you, and congrats on all the progress.
Dan Barber: Thanks, Caroline.
Operator: One moment for our next question. Our next question comes from the line of Thomas Flaten with Lake Street. Your line is open.
Q – Thomas Flaten: Hey, good morning, guys. And I apologize, if I missed this Dan, but with respect to the upcoming studies that are going on, whether they’re pivotal or supportive, are the timelines in the October nine press release still valid? Maybe I missed it, but it sounds like some of them were there was only going to be the pivotal study in the fourth quarter. And I know you guys left the fourth quarter, first quarter window in that press release, but I just wanted to confirm that nothing has shifted from those expectations and at least in my mind, we’re kind of set.
Dan Barber: No. Thank you, Thomas. I’m actually glad you asked that question, so we could clarify. Yeah, the timelines that we put in the October press release just a few weeks ago, remain the same. The additional or supportive study that Franc asked about before and Carl will walk you through, just remember these are smaller studies. So a temperature study, a PH study, those are not significant bodies of work that take months and months to complete. So in terms of completing them and where we will complete them throughout the year, we feel comfortable that by the end of next year, we will have gotten through the work that we need to know, where we are in the application process.
Q – Thomas Flaten: Great. And then I don’t want to beat the deliver it two to five thing too much, but I’m just curious because there isn’t an orphan drug exclusivity in that age group or at least it doesn’t appear to be. Is there still a dual process review going on one with the review division, and one with the orphan drug folks?
Dan Barber: Yes, the process remains the same. So the Cedar Group, the review division within the FDA will complete their review and either give an approval or whatever else they give on the action date as they would with any application. And then at the exact same time, our understanding is, the orphan drug group would give its position on whether the patient population is free from an exclusivity block, or whether they believe deem it to be blocked by exclusivity. So we do expect based on what we know, that both would happen at the same time.
Q – Thomas Flaten: Got it. Understood. Understood. And just a quick one for Ernie and I know there tends to be variability here, but there was a substantial bump in gross margin. Just any comments on sustainability of that? Or should we expect it to be relatively variable going forward?
Ernie Toth: Hi, Thomas. Nice to hear your voice. So now on the gross margin, we would expect it to trend where it is on a year-to-date basis going forward.
Q – Thomas Flaten: Got it. Appreciate taking the questions. Thank you.
Operator: One moment for our next question. Our next question comes from the line of Raghuram Selvaraju with H.C. Wainwright. Your line is open
Q – Raghuram Selvaraju: Thanks very much for taking my questions. I was just wondering, if it would be possible for you to offer some additional context around the target dermatological indications that you intend to pursue, with the topical formulation that you had mentioned earlier during your prepared remarks?
Dan Barber: Yeah. Thanks, Ram. And so I think the best way to approach giving you more information on that front is, there are a variety of indications that we could look at but it really depends on how the absorption process works, as we go through this first study. So I think a good way to educate all our listeners would be Steve, if you could talk a little bit about how you see the absorption process happening and what you think the potential effects of that could be, with our people with our ADRENAVERSE platform.
