Stephen Wargacki: Good morning, Frank. Good to hear your voice. Yes, I’m glad you brought up this topic, because in our view, there appears to be some confusion out in the world around edema and what is experienced by someone going through the process of anaphylaxis. So edema – the onset of edema with anaphylaxis is a cascade, right? So it starts as a tingle, it starts as a change that an individual may feel. And, of course, if you allow time to go by it will progress and get worse. And that’s not just in the oral cavity that can be manifested in other parts of the body, nasal cavities, many parts of the body. So when we think about angioedema, we think about the need to dose quickly, right, which is exactly what our study will allow us to show.
In our allergen exposure study, we will expose individuals to whatever oral allergen syndrome they have, so cherries, mango, kiwi, whatever it may be. And the individual will work with the clinician to say what level of discomfort they are feeling. And we will then dose our products and, of course, track the pharmacokinetic profile of that product. So that’s going to, in our minds, show what a real-world experience looks like, right. As we’ve talked about in the past, you’re sitting there, you think you may have had something, your feeling is tingling, something is progressing, and then you take our product. What we don’t believe is realistic or something that happens in the real-world on any regular basis is the extreme edema that I know has been shared in other settings.
That’s just not the experience we hear from KOLs and experts. So we think the FDA did a very good job and we are very pleased with the way they worked with us to say, don’t do an angioedema study where you are trying to create this false level of swelling, instead, show people what it really looks like in the real-world. So we’ll have a patient-based study, right. These are patients who will be in the allergen exposure study. So we are excited to get that going and we’ll have more to say about that over the next few months.
Francois Brisebois: Thanks. And then if I could just squeeze in one last one here, in terms of Anaphylm, obviously, gigantic market, how does a company your size, can you just talk about a little bit, I know you’re doing a lot of work right now on this, but what can you share about commercial prep and maybe sales rep side and what kind of docs are you going after here? Thank you.
Stephen Wargacki: Yes. Yes, I think that’s another – as we learn more, and especially now as our balance sheet is appropriately sized, I think, size is a misnomer, right. We believe that a relatively modest sales force, and as I’ve said in the past, somewhere between 80 to 100 reps is a great place to launch this product. Not only that, while the entire market is spread across a lot of call points, because there is a general GP component of this, if you target allergists and pediatricians, the top five deciles can be targeted with 80 to 100 reps. So when I look at our nasal spray competitors and how they are approaching the market, I think, everyone has a similar approach. And I don’t think that you have to be a big, multi product pharmaceutical company to attack this market. This is perfect for a company of our size.
Operator: Thank you. Our next question comes from Ram Selvaraju with H.C. Wainwright. Your line is open.
Ram Selvaraju: Hi. Thanks very much for taking my questions. Firstly, with respect to the timeline for the submission of the Anaphylm NDA, based on your current objectives, with respect to the pre NDA meeting, can you confirm whether you still expect to submit the NDA before the end of this year, or if it’s possible that it could slip into next year simply because of the lag between concluding the pre-NDA meeting and completing the final pediatric study?
Dan Barber: Sure. Good morning, Ram. And I am glad you brought that up because there was, in our prepared remarks and in the supplemental materials we’ve given, we did show everyone something a little different than last time. And I want to make sure we’re clear with everyone what that difference is. We believe – so before, we had laid out a plan where we would do all of our studies and then go have our pre-NDA meeting. Looking at it now, we actually think it’s much more efficient for both us and the FDA, given that we’re moving so rapidly through the three supportive adult studies, we think it’s more efficient for everyone if once those three studies wrap up, we just have our pre-NDA meeting. And why? Because we want to show that data to the FDA anyway before starting the pediatric study.
So why not just turn it into your pre-NDA meeting? Especially since the pediatric study is a very straightforward study. We are literally giving one dose to a child between the ages of seven and seventeen who is over 30 kilos. And that’s it. So is it possible that things change? Of course. That’s our industry, right? Who knows? But our guidance, our goal, our focus remains exactly like we said it was before filing, by the end of this year. And we’ll do that by having a pre-NDA meeting at the end of our supportive studies and then doing the very straightforward pediatric study that we’ve laid out.
Ram Selvaraju: Okay, that’s helpful. And then secondarily, with respect to all of this discussion around the commercialization of Anaphylm and the likely sales and marketing infrastructure that would be necessary, can you comment on the following two things? Firstly, what kind of promotional effort do you anticipate is likely to be most applicable here? Let’s say in the hypothetical scenario where Aquestive launch of Anaphylm independently, is it digital marketing driven? Is there any meaningful DTC through traditional channels? What does that look like, just frame that for us if you can? And secondly, this may be a question for Ernie. The financial guidance that has been promulgated, particularly with respect to the length of your current cash runway post, the most recent raise, does that actually factor in both pre-launch as well as launch activities related to Anaphylm? Thank you.
Dan Barber: Sure, Ram. So also, a great question and something that’s really important to highlight for everyone. When you look at the launch of this product, and we have, by the way, done a considerable amount of effort over the last 90 days to start bringing in some commercial expertise, make some changes in our commercial organization, to be ready for Anaphylm, as well as bring experts around us. So, obviously, I’m sure Ernie will at some point in the discussion here, talk a little bit about expenses. But that’s where we are spending our money, right, on R&D and commercial for Anaphylm. So having said that – so we spend all this money to build a commercial infrastructure, what are they going to do, right? And that is a – when you think about the 20-year span of this product being on the market, there is several phases.
