Gary Nachman: Thanks, guys. Good morning. So, first on Anaphylm and just a follow-up, I think, it was just asked but not answered. So on the pre-NDA meeting and the pediatric study, is there a scenario where you would file for just adults without that pediatric study, or is it just a question of confirming the design of that pediatric study that you laid out? I am assuming seven to seventeen is a big portion of the market that you need in the filing.
Stephen Wargacki: Yes. Good morning, Gary. I will admit to being disappointed you didn’t ask a Libervant question, since you’ve been with us on Libervant for quite some time.
Gary Nachman: I am not done yet. I have a question on that.
Stephen Wargacki: All right, we’ll get to that then, we’ll get to that. And I appreciate you asking that question so that I’m clear with everyone. We have no intention, I’ll even repeat it. We have no intention of filing our NDA without the pediatric component. So we are not signaling in any way that we are going to do just an adult filing. This is just, in our view, the most efficient way of getting to a complete filing. So, we would expect our label at launch to be the same as the EpiPen dose label. So 30 kilos and up in terms of ability to dose.
Gary Nachman: Okay. And just again, how long would it take for you to run that study? And just when you break down the market, peds versus adults, can you quantify that a little bit, just so we have a sense?
Dan Barber: Yes. My memory of the difference between peds and adults is somewhere around that fifty-fifty mark. So about half the market is adults, half the market is kids. In terms of how long it will take to run the pediatric study, we don’t believe this is a difficult study to run at all. It is – again, it’s a single dose, so there is no crossover, there is no having the pediatric patient come back and go again. So literally, the child comes in, they take a dose of Anaphylm, we track their PK for a period of time. And Steve do you recall how long we track for?
Stephen Wargacki: Few hours.
Dan Barber: A few hours primarily. So we do not believe that is a long study in any fashion.
Gary Nachman: Okay. And then on Libervant, so congrats on getting that approval in two to five. And I am curious, on the commercial side. So what you are doing now with Libervant currently? How much are you going to be able to leverage that for Anaphylm, setting up a distribution network? I know that Anaphylm is still a ways away, but how much of a consideration is that in terms of the investments that you’re putting behind Libervant? And then I also did want to get a sense from you guys, given the whole situation with the ODE, if you are expecting a challenge from Neurelis at some point on this approval? And do you think it’s even possible to sign a potential partner before having better visibility on that? I know ideally, you would like to find a partner if you can, but do you think you will need better visibility on the legal front for that to happen?
Stephen Wargacki: Yes. No, Gary, you know as well, it’s like you’ve been sitting in our boardroom with us. The Libervant products, the really, I’ll call it tantalizing thing for us with Libervant is if we were to keep it, we do get to build out pieces of infrastructure and not only build it, but get to use it well ahead of the Anaphylm launch. So think of distribution, payer access, all of those pieces you can almost think of it as getting the cobwebs out a little bit of the system before Anaphylm launch. So that is appealing. I don’t know, ultimately that that will drive the decision, because I think, we have to stay true to our mission statement, which is we want to help patients and you need to maximize getting this product into patients hands.
But it is definitely a factor that we are aware of. In terms of ODE, yes, really interesting situation on that front, as you noted. So first on our product, we are still in the waiting phase to get the determination from the FDA on our orphan drug exclusivity for the two- to five-year-old space. As I said in the prepared comments, we anticipate receiving ODE, there is no reason we shouldn’t. When we look at analogs, they received ODE. So we think that’s just a matter of waiting and seeing. So once we have that, obviously for our product, we would have seven years of the two- to five-year-old space for just our product and the existing products. In terms of being challenged on the approval and market access of our product, while obviously we don’t control the actions of any of our competitors, all we can say is as of 8:50 Eastern Time on May 8, we are not aware of a complaint being filed against the FDA by anyone.
So it is, as you know, is no small undertaking to effectively sue the FDA. You would think that if you were going to, you would want to get that started. So I don’t have any more color for you on what others will do in this space.
Gary Nachman: Okay. And then [indiscernible].
Stephen Wargacki: Yes, I am sorry, you did have one last part to that question. Yes, we absolutely do think it is – we can partner – we can license out the Libervant product at our discretion. I don’t think that from our interactions with the various companies that are interested, this does not appear to be a roadblock at this time.
Gary Nachman: Okay, great. Thank you.
Operator: Thank you. [Operator Instructions] Our next question comes from Thomas Flaten with Lake Street Capital Markets. Your line is open.
Thomas Flaten: Great. Thanks for taking the questions. Just on that last point, Dan, I know you guys had backed off a little bit your engagement with FDA around the six plus Libervant approval, because you wanted to get the two- to five-year old out. Now that that’s been approved, how are you thinking about reengaging with FDA, kind of on a major contribution to patient care basis to see if you can overturn the ODE that is in place in that space?
Dan Barber: Yes. Good morning, Thomas. And by the way, we noted you were the first one on the line this morning, so definitely impressed, considering you are in a different time zone. But in terms of your question on that front, I think, that the engagement with the FDA will happen. Sorry, I was looking across the room at my colleagues here. In terms of our engagement with the FDA we will, now that we’ve gotten this particular filing out of the way, we will pursue the adult again. As you know, while we think we have very good arguments, the wheels at the FDA move at a certain pace. So we will just continue to follow that process and see where it leads.
