Thank you for standing by. Welcome to the Aquestive Therapeutics Conference Call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. I will now hand the conference over to your speaker host for today. Faith Pomeroy-Ward, please go ahead. Thank you, operator. Good morning and welcome to today's call. On today's call, I'm joined by Dan Barber, Chief Executive Officer, and Ernie Toth, Chief Financial Officer, who are going to provide an overview of the company's recent business developments, followed by a Q&A session. During the Q&A session, the team will be joined by Dr. Gary Slatko, Interim Chief Medical Officer; Melina Cioffi, Senior Vice President Regulatory; Sherry Korczynski, Chief Commercial Officer; Cassie Jung, Chief Operating Officer; and Dr. Matthew Davis, Chief Development Officer. As a reminder, the company's remarks today correspond with a press release that was issued this morning prior to this call. In addition, a recording of today's call and related supplemental materials will be made available on Aquestive's website within the investor section shortly following the conclusion of this call. During the call, the company will be making forward-looking statements. We remind you of the company's safe harbor language as outlined in today's press release, as well as the risks and uncertainties affecting the company as described in the risk factors section and in other sections included in the company's annual report on Form 10-K, quarterly reports on Form 10-Q, and current reports on Form 8-K filed with the U.S. Securities and Exchange Commission. As with any pharmaceutical company with product candidates under development and products being commercialized, there are significant risks and uncertainties with respect to the company's business and the development, regulatory approval, and commercialization of its products and other matters related to operations. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. Actual results may differ materially from these statements. All forward-looking statements attributable to Aquestive or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement and the cautionary statements contained in the press release issued this morning. The company assumes no obligation to update its forward-looking statements after the date of this conference call, whether as a result of new information, future events, or otherwise, except as required under applicable law. Now, I would like to turn the call over to Dan. Good morning, everyone, and thank you for joining us today. As you saw in our press release this morning, on Friday afternoon, we received a communication from the FDA regarding our Anaphylm Epinephrine Sublingual Film application. This communication was a complete response letter, or CRL, indicating that Aquestive should conduct additional work prior to receiving FDA approval for the marketing of Anaphylm. We have provided the exact language from the CRL along with our comments in our supplemental materials, which can be found on our website. We would expect the FDA to publicly release the official CRL letter in its entirety in the coming weeks. Let me start by saying we feel validated to say that the FDA cited no deficiencies regarding pharmacokinetic or PK bracketing, repeat dose safety, and sustainability of Anaphylm's performance. There were also no CMC comments. We believe this indicates we have adequately convinced the FDA on major CMC safety and efficacy data for this program. While we are disappointed that we must conduct additional work prior to approval, I want to congratulate the medical, scientific, and engineering professionals who have been on an almost decade-long journey to gain the FDA's support for an orally delivered anaphylaxis treatment. We have developed the most robust epinephrine clinical database in the world to prove our science, and from the CRL received on Friday, we have achieved this major milestone. Having said that, we were frustrated to see the packaging, use, administration, and labeling feedback, collectively known as human factors, that was received in the CRL. Our view is that there was sufficient time to conduct these discussions during the review. We believe feedback on these items during the review process would have afforded us the opportunity to appropriately amend our NDA and risk mitigate these concerns and obtain a first-round approval. In fact, we already had alternate pouch openings and supportive human factors data available for the FDA had they engaged in these discussions. Unfortunately, we never received information requests on the human factors deficiencies received in the CRL. Regardless, let me walk you through the feedback from the FDA's human factors group called the Division of Medication Error Prevention and Analysis, or DMEPA. DMEPA is concerned that individuals will have trouble opening our pouch and may also tear the film while opening it. In our human factors validation study, only one individual did not open a pouch. This individual was a child, and it should be noted that we are currently using a child-resistant pouch. We had six instances of participants tearing a film while opening the pouch. All six instances resulted in the individuals fully dosing the torn film. We also want to remind everyone that we have shipped over 2.5 billion doses of products to five continents over the last 15 years, and after digging deep into our product complaint data, we only found one complaint related to a film being potentially torn and no data on difficulty opening the pouch. Having said that, we have previewed a revised opening mechanism to the FDA and believe use of this alternate opening will meet the needs of the FDA. DMEPA is also concerned about film administration location and sites chewing of the film. I should point out that four individuals out of 166 in our human factors validation study were recorded as chewing the film. Of those four individuals, only one was provided with the instructions for use prior to dosing. In reviewing the study videos, it is clear the individuals did not read the instructions on the pouch. Revising the pouch to include pictures should improve administration in those who did not read the instructions. Either way, we believe epinephrine absorption will still occur in the oral cavity and gastrointestinal tract. We have also demonstrated through our clinical studies that there is a wide range of acceptable placement for the film. DMEPA pointed to tingling, burning, and taste as potentially leading to premature removal of the film. At a top level, they refer to this as tolerability. Let's dive into this for a minute. In our 11 clinical studies, including pediatrics, we had zero instances of film removal. In our human factors validation study, we had four participants who removed the film. None cited the reason as tingling. Two cited taste and two cited a burning sensation. Keep in mind, these participants were in a low-risk, healthy environment and had no need for the medication. As one of the four individuals said during the study, "I don't like the taste of mint, but if we had to save my life, I'd even leave the film in for 10 minutes." Regarding the burning sensation, one of these participants administered two doses sequentially in an effort to get through the simulation quickly. As I stated earlier, engagement from DMEPA would have allowed us to discuss and explain this data. The FDA also provided us with a variety of labeling updates for our instructions for use and carton labeling. We were pleased to see labeling items in the CRL and will implement these in our revised submission. These label updates will be confirmed for their effectiveness in the human factors validation study the FDA is asking us to conduct. As of this morning, we have already designed a protocol and will look to move this forward rapidly. The other additional work needed is a simple, easy-to-perform pharmacokinetic study that ties to DMEPA's feedback about film placement. While we have already evaluated this and again believe this is unnecessary and repetitive, we see no issue in performing this work and providing it to the clinical team. We can do much of this work in parallel to the human factors study. As a reminder, we previously conducted a PK study on the impact of swallowing the film. So what does all of this mean for Aquestive and, more importantly, for Anaphylm? Well, from my perspective, this CRL, while unfortunate and seemingly unnecessary, represents a major de-risking event towards approval. We have a straightforward path to resubmission and expect to do so by the third quarter of this year. We will also work with the FDA to press for a rapid review and approval of Anaphylm once submitted to the FDA. In the meantime, we will continue to build our medical affairs presence and prepare for launch. We will also progress our ex-US filings and anticipate filing in both Canada and Europe this year. Finding the right distribution strategy and/or partnerships in both markets will now be a priority. With that, operator, please open the line for questions. Thank you. Ladies and gentlemen, as a reminder, to ask a question at this time, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, simply press star one one again. Please stand by while we compile the Q&A roster. Our first question coming from the line of Roanna Ruiz with Leerink. The line is now open. Hi, everyone. Morning. A couple of questions from me. First one, could you talk a bit about the resubmission timeline and are there any gating factors that you definitely need to complete before that when you're thinking about planning for it? Sure. Roanna, you said a couple of questions. Did you have another one or do you want me to answer that one first? Oh, my second one was bigger picture. Just thinking about Anaphylm's launch trajectory with the new potential approval timeline, how would you think about that going forward as well? Gotcha. Okay. Thank you. Good morning, and thank you for the questions. In terms of the resubmission timeline gating factors, as we laid out in the press release, the two things that we need to accomplish prior to resubmission are a human factors validation study and a single pharmacokinetic study using the revised instructions that were used in our human factors validation study. At this time, we see no other gating factors to get into a resubmission. In terms of the bigger picture in our launch trajectory, I'll turn that over to Sherry Korczynski, our Chief Commercial Officer here in a second. What I would say is, if you look at the market right now, the vast majority of the market remains autoinjector, and we believe that will continue to be the case in 2026. Thanks, Dan. Hi, Roanna. Yeah, as Dan mentioned, the market continues to grow, and if we look at what has happened over the last 18 months, patients, caregivers, HCPs are looking for choice, and the vast majority does remain in epinephrine auto-injectors. So as we look at it, our investment in commercial in 2025 will be relevant to our new timeline. We will be absolutely commercial-ready. And just one aside, we've been going through rounds and rounds of market research over the last three-four months, and I have to share with you, seeing is really believing. When we send samples of our demos, excuse me, of Anaphylm as well as the other products on the market, when a patient sees, feels, touches Anaphylm as well as the other products, 96% of the time, patients are choosing Anaphylm. We absolutely believe the market, with continued growth, will be ready for our launch when we do launch the product. That makes sense. A quick follow-up for me. You alluded to this a little bit. You had an idea of how you wanted to design the human factors testing and the PK study. Are there any other details that you could elaborate on just to help us understand what it looks like? Yeah. The details of the design will definitely be talking about in the weeks to come. Let's talk about the process for a second. We first have to take those details to the FDA in a Type A meeting request, which Melina and team will be doing very quickly here, and then we'll, of course, be sharing that with the world. What I would say at a top level, these are pretty simple designs. This is not a hard lift. Great. That's helpful. I'll hop back in the queue. Thank you. Our next question coming from the line of Kristen Kluska with Cantor Fitzgerald. Your line is now open. Hi. Good morning, everybody. Sorry to hear about the CRL, but genuinely very appreciative of how transparent you've been with us, including with the letter last month. On the PK pharmacology work, can you give us a sense of whether or not you see any risks into this study? Do you suspect it'll read out similar to what you did the first time around, especially now that there's the potential that you don't have to worry about any of these situations where the film either rips or people are not administering it correctly, etc.? And then I have a follow-up. Sure. Yeah. So let's back up to what we've done to get here, right? And then actually, in a minute, I'll throw it over to Gary, who can give you some of his thoughts as well. We've conducted 11 clinical PK studies over the last few years. So this will be study number 12. We know our film inside and out, and while there's always risk with any clinical study on anything in this industry, we believe we understand the clinical pharmacology of this product very, very well. So we think the design is straightforward. We think the process is one we know well and one that we have been successful at through the first 11 studies. But Gary Slatko, our Interim Chief Medical Officer, I'll let him share his thoughts. Yeah. I think reading the CRL, it just defines a clear path for us to follow to gain approval. The response gives us great confidence in the PK profile of the product and the safety profile, and it tells us that the FDA concurs with that. So a lot of the uncertainties are being removed by the information, the feedback that we're getting from the agency. And many of the things that might be uncertainties, they are opening the door to the labeling as a potential path of addressing those uncertainties. So that's a good news story because labeling is the end of a process of agreeing with the agency about how the product can be used effectively. Okay. Can you confirm your understanding about whether it'll be a single or repeat dose study? And then on the tolerability aspect, you alluded to two patients describing it as burning and two just outright not liking the taste of mint. I guess, how do you address that in a trial? Do you just give people more of a heads-up about what to expect from the flavor? Yeah. Thank you, Kristen. In terms of a single versus repeat, the ladder, which, by the way, in our supplemental materials, everyone has the ladder, so we didn't leave anything out. The FDA does not request or require a repeat dose. So they leave it up to us. So that will be something that the team determines, puts before the FDA, and then we'll, of course, share with all of you the exact design of the clinical study. In terms of tolerability, I'm glad you asked that question because, as you can imagine, and I'm sitting in our conference room with the entire team here, we spent the weekend talking about the path forward and also looking at videos from our human factors study, so really trying to understand the FDA's position or DMEPA's position on tolerability. I have to tell you, when you see how people react, it's not what you would think when you think about a bad tolerability case. I'll go back to the individual I put in my prepared comments. The individual is just providing information. So they are a teenager sitting in a room being told to do something. They do it, and they say, "Oh, yeah. Well, I don't like the mint flavor, but I would do it if it was going to save my life." So I think context is really important here. And one, we never had the opportunity to give that context, but now that we have the opportunity to rerun a study, you're right, there are things we can do to make sure that the subject is more prepared and will, of course, put those in and give better context to the FDA of what we're actually experiencing in our validation studies. Appreciate it. Thank you so much. Thank you. Our next question coming from the line of David Amsellem with Piper Sandler. The line is now open. Thanks. So a couple for me. First, just wanted to clarify that this additional PK study, is it going to have any repeat dosing or is it not going to have repeat dosing? That's number one. Sorry if you asked this, but just wanted to make sure I'm still clear on that. And then secondly, I'm just trying to get inside the head of the FDA regarding, quote, "tolerability" here. Are they just simply worried about incorrect placement of the film and potential swallowing parts of the film that causes tolerability issues? I just want to better understand what are they hung up on regarding tolerability, particularly since you've done the work where the film has been swallowed, at least in whole or in part. So just help me better understand what you think their thought process is here. Sorry if that came off as a loaded question, but I'm trying to better understand this as well. It doesn't, David. I think it's a very fair question and appreciate it. So first on the repeat dose, I'll lean forward for the clinical team. I was trying to give them space to do their work that they need to do over the next few weeks, but right now, we don't see a need to do a repeat dose. So while it's always something we have available to us, the FDA is not requiring it, and we don't see why we would do that. In terms of tolerability, I would divide it between two groups, right? From a clinical perspective, we think the clinical pharmacology team is bought in. In the pre-filing process and during the review, as Melina's talked about before, with the clarity we went through with the clinical pharmacology team, we talked a lot about tolerability, and we think they're sufficiently bought in. We think the tolerability comes down to, again, the DMEPA group, the human factors group, and we think what they're talking about from what we see in the letter is, "Will people remove the film once they put it in their mouth?" which is why we went to, "Well, how many people did that in our clinical studies? None. In our human factors study, four." When we look at those four individuals, again, three of them didn't even have the instructions of what they were supposed to be doing. So we think this is about communicating how our product is administered, not that there is an AE tolerability issue with the program. We believe that has been settled. Okay. That's helpful. And if I may just sneak in one more, just to be clear, the DMEPA group, are they so they mentioned removing the film. Were they also concerned about potential swallowing of the film? And I would imagine that's something that's readily addressable via instructions for use. Is that a good way to think about it? Yeah. My personal opinion, and I'll actually give it to Melina in a second here to give her view. I don't think the human factors group would be the one that would really have to be concerned about swallowing. I think that would be clinical pharmacology. And look, we've already done that work for them, right? But Melina, I'll let you give your thoughts. Sure. So I would absolutely agree. We've done these 11 studies really with the intention of fully characterizing our PK profile under conditions of real-world situations. So that was really driven by the clinical pharmacology and clinical team overall, and that really is the intention, in my view, of what this additional study would be looking for. But from a DMEPA perspective, it's really with respect to appropriate administration. Okay. And then just last quick one for me. Just to be clear, there were no issues raised on safety, nothing about blood pressure, heart rate elevations, anything like that. You can be confident that that's essentially an issue that's not at all problematic. Well, let's focus on that for a second, and I will give it to Melina in a second. I'll first preface it by saying not a single word, but I'll let Melina explain to you or explain to other people because you probably already know, David, what that means. Sure. So a Complete Response Letter is intended to be a complete outline of any outstanding issues or questions that the agency has upon completion of the review. So the absence of mention of things like the repeat dose safety, sustainability, overall safety profile certainly implies that the review has completed and there are no major objections, concerns, or issues. Okay. Very helpful. Thank you. Thank you. Our next question coming from the line of Andreas A rgyrides with Oppenheimer. Your line is now open. Good morning, and thanks for taking our questions here. So it seems from the answer to questions and the pre-prepared remarks that you feel like the PK pharmacology work is somewhat trivial. But just maybe since and also that you guys can conduct this kind of at your discretion, maybe you can give us a sense of how you're thinking about it initially. Is it multiple arms? Do you plan to conduct it under bracketing, especially in a comparator setting? And you did say these are pretty feasible. Any sense of how long they'll take and what age groups might need to be conducted? And then just to you said you had a better you had a better container design to begin with. Maybe your thoughts on your decision not to kind of preemptively submit those. What were some of the considerations around that? And then maybe one more follow-up. Yeah. Thanks. Yeah. Well, I'll start with the end, and then I'll hand it over to Matthew Davis, our Chief Development Officer, to talk about the PK study in particular. But let me be clear on the foil opening. We are always looking to improve our foil opening, right? And we have done that work in the past, and we did submit it to the FDA during the review process. And at the point we submitted it, they did not look at it in this review cycle. So that was frustrating to us, but it is what it is, and now we'll do the work to get to the approval. In the meantime, I'll let Matthew talk about the PK study. Well, thank you. First, I just want to acknowledge we have a highly experienced clinical operations team. This will be their 12th PK trial. So this is something that we've done. We know how to do. We have excellent vendor partners. So we're also very appreciative that the FDA very clearly mapped out the design that they wished. So they want us to look at chewing with and without swallowing. They want us to look at alternate sites, and they want us to be informed by our human factors trial and allow for self-administration. The FDA requested that we had an injectable comparator. And also one other additional thing the FDA wanted is for healthcare practitioner placement, so the film to be placed on the participant. They're allowing us to do parallel or sequential design, and we're going to pick the design that works out best for the information gathering, the timelines, and that would also be reviewed at the Type A meeting. All right. Thank you. I'll step back in the queue. Thank you. Our next question coming from the line of Raghuram S elvaraju with H.C. Wainwright, right? Your line is now open. Thanks so much for taking my questions. Just wanted to break this into three different topics. Firstly, if you could comment on the projected size and scope of the human factors and PK studies in terms of what you anticipate to be the estimated total number of subjects that you will need, if it's possible for you to provide us with any granularity on that point. Secondly, I was wondering if you could maybe clarify what the status is of dialogue around a potential label? And even though the original communication you got from the FDA that was disclosed prior to the receipt of the CRL indicated factors that precluded labeling discussions at that time, it appears from the press release that the FDA has, in fact, provided you with commentary on a potential label. So I just wanted to see if you could just characterize for us at this point what the status is of discussion around a potential label for Anaphylm. And then lastly, given the need for additional data to be provided as part of the resubmission, can you clarify for us that, in fact, this would be classified as a Class 2 resubmission? And in such a situation, if that would essentially imply the potential approval of Anaphylm in 2027 as opposed to before the end of 2026? Thank you. Sure. And good morning, Ram. Thanks for the questions. In terms of the size and scope of the studies to be run, I'll first ask Melina to talk about the size of the human factors study, and then Matthew can comment on the PK size. Sure. The human factors study expectations are outlined by the agency in human factors guidances. The expectation generally is that it would be 15 participants per arm. We would be expecting about 75 participants overall. And Matthew? When you think about pharmacokinetics, you think usually about 18-24 participants per arm. So if you go in a parallel design with three arms, which the FDA is allowing us, a chewing arm, an alternate site arm, and a human factors arm, you would have three arms with that bracketing. It was a bad choice of words. Three arms with that amount of participants. If you go sequential, then you'd only need anywhere from 18-24. We'll look and see what's best for getting the data to the FDA, and we will discuss that at our Type A meeting. So Ram, clearly within the usual size of studies we've performed in the past. In terms of clarifying the status of the dialogue on labeling, yeah, we obviously this weekend was a strange weekend for us as a team, both frustration as well as obviously excitement over the places we have alignment. Really interesting to see so much labeling in the actual CRL, labeling feedback. So while we can't have an active dialogue right now while we're waiting for the process, as we go to the Type A, Melina and team will definitely be engaging in more of those discussions. Melina, was there anything you wanted to add to that? I would just add that the feedback from my experience, the feedback that we received in the letter, the CRL, would normally be given during the review. And so in terms of the status of the discussions, it's quite unfortunate that we were unable to have those conversations during the review process because, again, those are commentary that would normally be discussed towards the end of the review. Yeah. In terms of the classification, yeah, of course, you have it right. Just to provide a little more detail, the standard review time after submission with the clinical data we'd be putting in is six months. Having said that, I do want to remind everyone that in this particular category, with this particular review group, a competing product had a six-month clock and got approved in four months. So we're very aware of that. We will be pushing hard, and we'll see what happens. And then just one quick follow-up. Do you anticipate being able to conduct the Type A meeting before the end of this quarter, or would it be more reasonable to assume that it could conceivably occur early next quarter? Thank you. Look, we're going to move as fast as we can. The Type A meeting process with the FDA is designed to get us in front of the review team quickly, and we're going to do that as quickly as possible. Thank you. Thank you. Our next question coming from the line of François Brisebois with L ifeSci Capital. Your line is now open. Hi. Thanks for the questions. Is there this kind of lack of communication here with the FDA? Is this somewhat maybe related to the shutdown or anything? Is it a different crew at the FDA? Because it just seems like a lot of this could have been taken care of if the communication had been better. So is there any insight there at all? Frank, your guess is as good as ours. What I would say is and you've heard Melina say multiple times over the last year that the review with the clinical team up until in December when we received the deficiency letter was very, very good. I think our best guess is that the clinical review team was following protocol based on whatever debate was happening inside of their four walls, and we just weren't allowed into the discussion. Okay. Then it seems like swallowing came up there, but you guys have shown data there. Can you just maybe touch on a couple of things that you mentioned, kind of the childproof feature of the package? Is that something that would be worked on, or it's just more like, "Let's read the directions better," and whatnot? Then just touching on the swallowing coming up again and then the chewing aspect that you mentioned there, just remind us what you said and why you feel comfortable there. Yeah. I think the relativity is the first place to go. Remember the hundreds of people who have gone through our clinical studies and our human factors studies, and we're talking about four individuals, right? So we're talking about a very small number of individuals to begin with. In terms of improvement, there's always improvement to be made, and we will as time goes on. We couldn't focus on it this weekend. We will share with everyone the revised pouch that we're considering and the revised opening. And as time goes on, we'll probably continue to improve things. But just to give you an example, the pouch we studied in our initial human factors validation study did not have a picture on it. The new one does. So simple things like that really help people to better understand if they're not going to take the time to read the instructions. So we feel very good about our ability to continue to improve on the human factors side. In terms of swallowing, look, we've already outlined work in our initial clinical studies. We've done that work. Our read of it is the clinical team is well on board. I think they just want verification with the new instructions. So we don't see swallowing in particular as a major hurdle or something that is problematic in the CRL. As you've mentioned, maybe my last question is, you guys have been through a lot of this. You've produced these types of sublingual films and buccal tabs for a lot of different companies now. Is this packaging something that had been used in other products and just never came up with the FDA, or is there any surprise here? Is this more of a, yeah, emergency situation or whatnot? Yeah. I'm only chuckling, Frank, because it's unfortunate, but this opening is the one we use with multiple other products that are on the market and one product that's been on the market for 15 years. And as I laid out in my prepared comments, there's no data in our product complaint. And I probably should define that a little bit better for everyone. So when you're a company that produces product and puts it into the market, there's a 1-800 number as everyone knows on your product, and complaints can come into that 1-800 number. As the manufacturer, we're responsible to review and respond to all complaints on our products that are out in the public, right? When we look at the products that we have in the public domain, including with the opening that we're using on this product, we don't find complaints on tearing the film or having difficulty opening the pouch. It's a bit of a head-scratcher, but we'll do the work as the FDA has requested. Okay. Great. And then I'll add, I guess, maybe last one. I think Ram mentioned it, but the timing there. So you mentioned that based on the data that you have to present and all that, usually it'd be six months, then a competitor had it done in four months. Is that normal review, or is that rapid review like you mentioned in the press release, or could it be more than six months? I guess is my question. No. The most it would be is six months. The longest clock is six months. Okay. All right. Great. Thank you. Thank you. Our next question coming from the line of Thomas Flaten with Lake Street Capital Markets. Your line is now open. Hey. Good morning. Appreciate you taking the questions. Just kind of sweeping up here. Sherry, what impact is this going to have on recruitment for the sales team? I know you probably had some contingent offers out, but I'm just wondering if you could comment on that, how much rework you're going to have to do to get those salespeople lined up again, let's say, 12 months from now? Thanks so much for your question. As you know, and we stated in the past, we were not planning to hire our salesforce until approval. And so fortunately, then we did not have to let anyone go. As it relates to recruitment, we were very successful in having our district sales managers, our sales representatives lined up. And so obviously, those will be people we'll go back to first, and then we'll be filling in from there once we get closer to an approval date. Does that answer your question? Yeah. No, that's great. I appreciate that. And then Dan, a little bit left field, but you did mention moving forward with Canada and EU. submissions by the end of the year. I saw that neffy got a positive CHMP opinion this morning. I'm just curious if you guys have been monitoring that and if there are any learnings, what dialogue you've had with the Europeans to kind of advance that program, and any thoughts on that? Yeah. Well, I would say with our program, the FDA feedback we just received is actually way more important for us and where we're going than the competitor information. It shows that the FDA on the big questions that were around our program is bought in. So we think from an EMA and Health Canada perspective, that gives us a green light to move forward rapidly, and which we are planning on doing. I also do want to back up Thomas for a second if you're okay and just give Sherry and her team some credit. The work they did in 2025 was phenomenal and will remain available to us as we go to a launch in late 2026 or early 2027, wherever that falls. All the marketing work, all the awareness work, she has a phenomenal team that will remain in place, and we're ready to go on that front. Got it. And then one quick one at the end. So just from a promotional perspective, I'm assuming because this isn't like taking a pill, which anyone can do without too many instructions, I'm assuming you'll have demo units for the doctors to explain to their patients how to use these. And then how important is that going to be, do you think, in reinforcing the fact that people aren't going to not read the instructions because they've already been trained on it by a physician? I know that's probably not what FDA wants to hear, but in the real-world application, I feel that would be critically important to getting patients to understand how to actually use the product, where to place it, etc. Yeah. Well, I'm going to throw it to Sherry in a second to talk about some of the things we'll be doing in the doctor's office. But let's be clear about the situation here. And actually, Gary, you can probably say it better than I can. When you think about someone who is actually in a crisis moment and has a lifesaving drug on them, I mean, how do you think about it? Well, I think this is a rescue medication, and they are going to do everything they can to administer the medication properly. Most people would get some kind of direction about use through their healthcare provider or pharmacy, or they read the pouch in advance of having an event that would necessitate its use. And once you do it once, you've got it. And so this product would probably be used once or twice a year. People will use it under an emergency circumstance, and there will be a learning and practice effect that patients experience once they have used the product. Sherry, do you want to tie that to the office? Yeah. Sure. Thanks for the question. We know it is critical for the physicians, patients, and their caregivers to know what to expect. And so we have a whole slew of materials that will be available to the offices and to the patients, things like demo films so that they can practice the right placement so there's not challenges in an emergency situation, QR codes that are able to show how to put the Anaphylm under the tongue, but also things like patient starter kits and training for the physicians, patients, school nurses. So we take it very seriously that it is an emergency situation, and in an emergency situation, we will be providing all of the materials so that they're aware how to use, when to use, in advance of a severe allergic emergency occurring. Great. Appreciate it. Thank you. Thank you. Our next question coming from the line of Jason Butler with Citizens Bank. The line is now open. Hi. Thanks for taking the questions. I just wanted to follow up there, Dan, on your comments about crisis situation, rescue medication. Are there any learnings that can be pulled from the tentative approval of Libervant to this FDA conversation? Because obviously, that's also a rescue situation. And then second question, can you give us color on what language or data you had proposed, including in the label from the oral allergy study, and if the FDA had made any comments on the inclusion of those data in the label? Okay. Well, let me start with the first piece, and then I'll hand it over to Melina on OAS and what could have been in the label. Well, sure. There's always learnings from any of our film programs, especially a rescue one like Libervant. I would actually point more towards the medical devices that are on the market for this particular indication. Look, the DMEPA exists for a reason inside the FDA, right? There are errors. And those errors, especially in medical devices, are around misfiring, misuse, misunderstanding, prepping a device when it doesn't need to be prepped. So that's the lens that the DMEPA uses on any product, which, by the way, our product, not being a device, actually technically doesn't require the DMEPA review. So they've put it under that review, and so we're providing them with the data that they require. But I think when you compare us to the devices that are out in the market, the inherent ability to use our product, I believe, is very good. But I'll pass it over to Melina to talk about OAS. So with OAS and the label, yet again, it would have been really nice to have been able to have that dialogue with the agency during the review. But I will just point out that with OAS, again, in the context of this complete response, there are no outstanding questions or concerns with respect to that data. Okay. Thank you. Thank you. Our next question coming from the line of Jim Molloy with Alliance Global Partners. Your line is now open. Hello. This is Laura Suriel on for Jim Molloy. Thank you for taking the questions. So alongside the info you provided on the Canada regulatory expansion, can you just give a bit more insight on the other global expansion plans you have for Anaphylm and how the discussions and the plan submissions you have with these other regulatory agencies have been going? Sure. Happy to. I'll actually pass it over to Melina to walk you through Canada, EMA, and the U.K. Thanks, Dan. So we have had a pre-submission meeting with those two health authorities, and we have a clear path forward. Right now, it's just a matter of putting the package together, crossing the Ts, if you will, and dotting the i's. We do have an upcoming meeting as well with MHRA, and that will certainly inform the path forward in the U.K. as well. Got it. Thank you for the clarity. And also just on the AdrenaVerse platform, I believe prior guidance detailed on an upcoming IND filing and the start of clinical development this year. So do you think the new timelines you have for Anaphylm could potentially affect the timelines you have planned for AdrenaVerse and AQST-108? That's always a good question for a small company, right? And I think some of my team is looking at me right now to see how many weekends we're going to have to work this year. So look, it's always a balance, right? We believe in the AdrenaVerse. We believe in AQST-108. With the addition of Matthew Davis last quarter, who is doing a phenomenal job as our development officer, we have a really good plan to make sure we understand the value, the long-term value of the AdrenaVerse platform. What I would say is in the next 30, 60 days, we obviously have a lot to accomplish on Anaphylm, and we're going to be very focused on that. But given the value and the multiple important products we think are in our AdrenaVerse platform, we absolutely will be continuing that work and looking to give you more detail on where that can take us in the years to come. Understood. Thank you for taking the questions. Thank you. I'm showing no further questions in the queue at this time. I'll now turn the call back over to Dan Barber for any closing remarks. Thank you, Livia. Thank you, everyone, for joining us this morning. We appreciate your time. Obviously, a CRL is a very frustrating thing to receive from the FDA and unfortunate in this scenario given the facts. But we are as confident as ever in our program, what it means to patients, and the importance of this product and product choice in this space. And we are steadfast as we put in our press release on making sure we get to approval. And today, we believe we are much closer to approval than we were last week when we were still waiting to hear from the FDA. With that, we will close the line. This concludes today's conference call. Thank you for your participation, and you may now disconnect.