Good morning. My name is Yale Jen, Senior Biotech Analyst of Laidlaw & Company. We appreciate your attending our fireside chat this morning to discuss the real-world GIMOTI benefits over oral metoclopramide from the recent DDW, Digestive Disease Week meeting presentations. We will also have additional discussions of other relevant issue in treating gastroparesis with the author, Dr. David C. Kunkel. Overall, we believe this is the first major academic analysis providing a tangible and quantifiable benefits of GIMOTI. Let me begin first, that, we are very honored to have Dr. David C. Kunkel from UC San Diego, to provide his analysis and discussion with us. He is an Associate Clinical Professor of Medicine and a board-certified and practicing gastroenterologist, specializing in the diagnosis and treatment of gastrointestinal motility disorders such as GERD, gastroparesis, bloating, and other disorders. He's a member of the American Neurogastroenterology and Motility Society and was a recipient of the Training Award in Motility in 2013. He also is a member of the American Gastroenterological Association and the American College of Gastroenterology. Dr. Kunkel also has conducted researches in various gastroenterological disorders such as gastroparesis and short bowel syndrome, and he has been published with more than 30 articles in peer-reviewed journals. Welcome. Thank you, Dr. Kunkel. First, could you provide us more information about yourself, if I have missed anything during the introduction? Could you give us some information about your medical practice, such as average number of gastroparesis patient you have treated per week or maybe per month, and how frequent, if you need to prescribe GIMOTI? Thank you. Thank you, Yale, and good morning. I am based at the University of California, San Diego as you mentioned. I'm a gastroenterologist who subspecializes in motility disorders, and we have a tertiary referral motility practice. Every single patient I see has a motility or movement disorder in the gut. Gastroparesis, of course, features prominently in that group. Gastroparesis refers to patients where the movement of food from the stomach is slow or impaired, giving rise to a number of symptoms. We have a huge catchment area here in Southern California, extending well beyond San Diego County to Imperial County, Riverside, and Northern Mexico as well, and our practice has a significant proportion of medical tourism, so I'm seeing folks from all throughout the country. With COVID, we've seen a telehealth boom, so anyone in California, anyone in Arizona now can request an appointment with me and can have that without needing to present in person. I see a lot of gastroparetic patients every week. I'm seeing at least 10 new patients per week, and I've written multiple prescriptions for GIMOTI. Okay. Go ahead. Go ahead, Yale. Okay, great. As a start, I would like you first to provide us a brief summary of your oral presentation at the DDW meetings and of the reduction of the real world Healthcare Resource Utilization or HCRU for the diabetic gastroparesis patient, treated with oral versus intranasal metoclopramide. Afterward, I will have some questions, and they can be categorized into two groups. The first is related to the presentation, and the second will be a much more broadly in terms of gastroparesis and the use of GIMOTI. Please go ahead for the DDW presentations. Absolutely. I'm really pleased to share this presentation with you and our audience today. To give some background, I'm a reviewer for DDW myself, and this presentation made it not only through our section of gastroparesis, but it was elevated multiple rungs above our section. Meaning people, gastroenterologists, who don't treat gastroparesis, reviewed this data and said, "This is so important," that it was selected for plenary presentation. Meaning it was designated one of the most important abstracts in the prior year and in the area of clinical practice. Gastroenterologists who treat patients, not necessarily, you know, basic science or translational science, but on the front lines. This research was presented in the abstract in the oral plenary session, dedicated to the most impactful clinical practice abstracts. It was right there with the latest on colon cancer and inflammatory bowel disease. That really reflects the importance that was recognized by multiple layers of reviewers, extending beyond the motility and gastroparesis space. I'm excited to talk about it, and really this is about the significance of metoclopramide administration route. I think the signal. Typically comparing the nasal delivery route, which is what GIMOTI offers, versus oral metoclopramide. My disclosures are listed here. I receive support from Evoke Pharma, the developer of GIMOTI. Diabetic gastroparesis is a chronic stomach disorder characterized by delayed gastric emptying, and it leads to cardinal symptoms, including nausea, vomiting, feeling full quickly, what we call early satiation, bloating, and abdominal pain, which can be severe. In 2022, the prevalence of gastroparesis was 267 per 100,000 U.S. adults, with diabetes constituting the most common cause. The symptoms of diabetic gastroparesis not only impact the quality of life for affected individuals, but also lead to poorly controlled diabetes, which increases the risk of mortality. To manage these symptoms, patients typically follow dietary restrictions, use antiemetics, which are medicines that reduce nausea and vomiting, and undergo treatment with the only FDA-approved medication, metoclopramide, or resort to surgery and implantation of stimulator devices, for example. Most patients with gastroparesis have expressed dissatisfaction with the available treatment options, and I would say this is mirrored by physicians and healthcare providers as well. The economic impact of diabetic gastroparesis is substantial, with patients experiencing three times greater emergency department costs, three times greater inpatient admission costs to the hospital, and twice the outpatient costs compared to non-gastroparetic patients. In the middle of COVID, the summer of 2020, GIMOTI was FDA approved, and it was the first non-oral outpatient treatment for patients with diabetic gastroparesis. It had to go through bioequivalence testing to oral metoclopramide, phase III, double-blind, placebo-controlled trial, and GIMOTI patients experienced significant reduction in their symptoms compared to a placebo group. What's so powerful with GIMOTI, which is gonna be abbreviated as NMCP on these slides, for nasal metoclopramide, is, you know, what I refer to as the GIMOTI jump. It becomes active, present in the bloodstream within minutes. Keep the GIMOTI jump in mind as we go through this data. That's its advantage over oral metoclopramide. After it became FDA approved, then immediately it becomes possible to assess the so-called real-world impact that it's had. Our research objective is to compare the frequency of physician office, outpatient facility, emergency department, and inpatient admissions for patients with diabetic gastroparesis who were treated with nasal metoclopramide versus those with oral metoclopramide. By understanding the differences in Healthcare Resource Utilization between these two treatment options, we aim to provide insights into their effectiveness and potential impact on patient outcomes and healthcare costs. That is what we set out to do. How can you go about answering that question? We retrospectively identified GIMOTI patients by linking specialty pharmacy data to the Symphony Health Integrated Dataverse via Datavant. We included oral metoclopramide patients who had diabetic gastroparesis and who initiated treatment between June 2020, which is when nasal metoclopramide or GIMOTI, was approved, and December 31st, 2021, and were adults. Importantly, patients needed to have a minimum of six months data before and after what we call continuous capture. We needed to have a full data set. We used this validated technique called propensity score matching to match oral metoclopramide patients to GIMOTI patients based on age, sex, region, Charlson Comorbidity Score, how sick someone is, and any six month hospitalization or emergency department visit pre-index. We compared mean all-cause visits and also separately, diabetic gastroparesis and symptom-related visits for physician office, hospital outpatient, inpatient hospitalization, and emergency department between these two cohorts for the six months following treatment initiation of oral metoclopramide or nasal metoclopramide. We carried out a statistical analysis, which I will spare you from going into, unless we've got any statisticians on the line. This is what it looks like. You can see millions of people, millions on oral metoclopramide, and we winnowed that down to 257 that matched the nasal metoclopramide patients. That's what this slide is detailing. Matched in what sense? How sick they were, age, insurance, how often they were visiting the emergency department, hospital, and their doctor in the six months leading up to the comparison point. We propensity score matched the patients one to one. We wanted to ensure that we captured complete follow-up on these patients. Red dots are pre-propensity score matching, and blue-green dots is our post-propensity score matching. I'm gonna make this real easy. Red dots are bad, and we want everything to be blue-green. That means you're matched. From those $2.9 million, winnowing them down to the 257 that look just like the nasal metoclopramide patients. That's what this slide is demonstrating. After we go through propensity score matching, then we can take a look and see, all right, how did the GIMOTI patients compare to the oral metoclopramide patients? These two groups should be quite similar if the propensity score matching has worked out. You can see they absolutely are. Here are the clinical characteristics of these two cohorts. After matching, the average age of patients was 53 years, 77% were women, and over 60% were commercially insured. Exactly what we would think about in terms of the demographics that we see for patients who have diabetic gastroparesis in the U.S. This is predominantly a female population, and these are folks who are in their fifth decade of life on average. So once we've done that, now we can then see, well, how did things turn out over the six months afterwards? Specifically with an eye towards patient outcomes and Healthcare Resource Utilization for this very expensive condition of diabetic gastroparesis. This is a really important slide, and the green here is the GIMOTI or nasal. Excuse me, I have that backwards. The green is our oral metoclopramide patients, and then the light blue is the GIMOTI or nasal metoclopramide patients. This slide is showing that we found that patients treated with GIMOTI experienced a significant reduction in visits and hospitalizations across three key healthcare settings: office visits, trips to the emergency department, and the most expensive thing on the planet, inpatient hospitalizations. Just in the six months following this separation between nasal metoclopramide and oral metoclopramide, patients had an average of 0.68 outpatient visits, compared to 1.1 visits for the oral metoclopramide cohort. If we do some math, this translates into a reduction in physician office visits of 99 fewer visits for these 257 patients in six months. This translates into 84 fewer emergency department visits, 34 fewer inpatient hospital admissions over the same six month period. No doubt, this is the data that led to this presentation being elevated to oral plenary at DDW. This slide shows all-cause healthcare resource utilization. If we look beyond just diabetic gastroparesis, any type of healthcare visit, was there a reduction? This encompasses the full range of situations from COVID-19 infections, which were raging at that time, to broken bones. Sure enough, we found a significant reduction in physician office and emergency department visits among the GIMOTI cohort. This would have led to 124 fewer physician office visits, 55 fewer outpatient facility visits, 37 fewer hospitalizations, and 167 fewer emergency department visits for any cause, comparing the GIMOTI cohort versus the oral metoclopramide cohort. In terms of diabetic gastroparesis-related Healthcare Resource Utilization, the difference in absolute rates of resource utilization led to a 36% reduction in the likelihood of visiting a physician's office, a 68% reduction in the likelihood of being admitted to the hospital, and a 60% reduction in the likelihood of receiving care in the emergency room for patients treated with GIMOTI. These reductions were observed over a six month period. These are what we call incidence rate ratios. To put this all together, to wrap this up, our large retrospective cohort study demonstrates that patients who receive nasal metoclopramide experience significantly reduced Healthcare Resource Utilization in the six months following treatment initiation. This finding translates into a substantial decrease in the burden of illness for both patients and providers by avoiding a significant number of visits across outpatient, emergency room, and inpatient settings. We hypothesize that this improvement is likely due to better control of diabetic gastroparesis, via the GIMOTI jump. Further research is, of course, needed to validate this hypothesis. As with any retrospective study, selection bias is possible. When you're applying inclusion, exclusion criteria in a retrospective manner, you can always be vulnerable to confounding. The propensity scoring, though, this validated methodologic approach, mitigates potential bias and the impact of confounding factors in our analysis. I'm going to pause here and Yale, I'd be happy to go through some questions with you. Thank you for your attention. Great. Thanks. That's a very impressive outcome. Again, as I mentioned earlier, these are very tangible and quantifiable attributes or differences, which is very important, I guess, in physicians' mind when they make the decisions of prescription. Let me start with probably two questions regarding your presentation. The first one is, as your DDW presentation illustrated, benefits of intranasal versus the oral metoclopramide is based on aggregate of patients. Could you give us some yours or maybe your colleagues' experience when you prescribe these two type of therapy at the individual patient level, and what have you observed the subsequent sort of impact reaction of? Maybe I have another follow-up after this. Absolutely. One of the most dispiriting things a patient can tell you, who has gastroparesis, is they were feeling nauseous, they were feeling bloated, they were on the verge of vomiting, so they took their metoclopramide, and then they vomited, and they saw the pill in their emesis or material they vomited. That's extremely soul-crushing because that pill is of no use once it's been vomited out. It's never had a chance to make it past that morass that is the stomach and get into the intestine, where it gets absorbed and then becomes active. In this space, we've all had our patients report that experience if they have vomiting. What I like hearing from patients where I ask them how things are going on GIMOTI. The feedback, of course, that I think resonates most is that it was more convenient and more effective than oral metoclopramide because they knew they weren't gonna vomit it back up, and they started feeling better within minutes because that's how quickly the drug gets absorbed. That's the kind of feedback I'm listening for, and that makes all the difference for a patient not to worry about vomiting back the medicine that's supposed to help them feel better. Great. That is very helpful. Maybe I'm going to drill down a little bit more specifically, as actually your first data slides suggest that the two symptoms, which is nausea and vomiting, which you highlighted. I just want to get a little bit more color in terms of these two. Why these two symptom you've been choosing for your presentation, and are those symptoms have the greatest impact on gastroparesis patients? Maybe I have another one in terms of the abdominal pain, and if you want to also elaborate more on that? Nausea is the most common symptom in gastroparesis. In fact, if someone does not have nausea, I almost question the diagnosis. We know from Henry Parkman and the Gastroparesis Consortium, that every symptom is the keystone symptom, really at the heart of gastroparesis. When we're talking about symptoms that we want to improve, then obviously we want to be addressing public enemy number one. It goes without saying, if you improve nausea and vomiting, you're going to have a significant impact on quality of life for these patients. Abdominal pain is a difficult symptom to manage because it's complex, multifactorial, the nature of pain perception. And I would say the pain piece often requires a multimodal approach. Yeah, absolutely, I'm happy to dive deeper into that, Yale. Okay, maybe just one follow-up on this one is: Once the vomiting and the nausea, as well as, abdominal pain, was alleviated, would patients feel most appreciated of that this level of relief? Was that the general experience you've seen from gastroparesis patients? The short answer is yes. If there's one symptom that I can improve, it is the nausea and vomiting piece. That's the most important piece. Guess what? Everyone here on this call, every human experiences nausea and vomiting, so this is not an abstract concept. This is something we've all experienced, and we all know how unpleasant that is. Fortunately for most of us, the frequency of those symptoms is reduced. If you're gastroparetic, this is either a daily or weekly symptom, and so it is the most important to address. Metoclopramide is unique among treatments for gastroparesis because it works both centrally and peripherally. What I mean by that is it helps the stomach empty more quickly. It addresses the gastroparesis piece, but it also acts centrally in the brain to reduce the burden of nausea and vomiting. Okay, great. That is very insightful and helpful. Maybe I'll move to the second part of a questioning, which is that much broader in general, you know, broader issues related to gastroparesis treatments. My first question here is that, among the various symptoms of gastroparesis, which one or combination that will trigger you to admit this person to a hospital? Generally, any severe or uncontrolled symptoms of gastroparesis could potentially necessitate hospital admission, but especially intractable vomiting, that can lead to dehydration, electrolyte imbalances, malnutrition, and in diabetic patients, dangerous metabolic disarray. Folks who have really bad vomiting, you know, can't eat, they can't maintain their fluids. Certainly that would be a reason to admit them to the hospital, where primarily what's done is to just bypass the stomach and put an IV in and start giving fluids and medicines through the IV. That's basically what is done, in addition to monitoring for downstream complications such as, you know, diabetic ketoacidosis. Okay, great. Also, based on the different levels of severities, what might be the treatment selection for you when you're treating gastroparesis patients? Treatment selection generally depends on severity of an individual patient's symptoms. Patients with mild symptoms, you know, dietary modification and one or two medications will suffice. Patients who have more severe symptoms and who have had multiple emergency department visits, multiple hospitalizations, that's where we're going to start thinking about advanced treatments, more invasive treatments. And those folks will be put in the severe refractory bin. Okay. Oh, that's very useful. Also, in patient, when patient fail, they're generally probably the first oral metoclopramide therapies. What may be the determining factors in selecting different other treatment options? I have another one follow this. The next line of treatment could depend on the specific symptoms that were not adequately controlled, patient preference, risk-benefit profile, side effects. Certainly, though, adequate absorption of the medication would be assessed based on, you know, symptom control. If somebody is vomiting out their oral metoclopramide, they're not having side effects, the pill is not getting absorbed, naturally, that would be a situation where we would wanna offer GIMOTI. Okay. I know most of the patient in gastroparesis have a number of morbidity at the same time in terms of different diseases. Would you be able to assess patients that because of they throw up the pills, that other sort of disease worsen or that kind of situation? Was there something else you need to managing or treat, maybe even in collaboration with other specialists? I'm on the hook if patients are throwing up their pills, because guess what? They're not only throwing up their gastroparesis pills, but they're also throwing up their diabetes management pills, their hypoglycemic agents, metformin, glyburide. The endocrinologists who are, you know, the diabetologists managing the patient's diabetes, if they've had a solid organ transplant and are on anti-rejection meds, which absolutely can't be vomited up, all of a sudden, you know, all the guns of these other specialists get pointed at me, the pressure is on. Absolutely, we cannot have this patient vomiting. They're going to reject their heart, their lungs. Their diabetes is going to be impossible to control if the oral hypoglycemic agents aren't being taken and processed in a predictable manner. These are situations where immediately we want to get on that. We want to leverage all the tools available, our full armamentarium. In some cases, that means just bypassing the stomach completely with use of an enteral tube. That's how important it can be to ensure optimal absorption of medications. Sometimes we just have to skip that waiting room that is these gastroparetic patients' stomachs. That certainly is important, given the severity of the sort of collateral damage, as I guess, to the patient, other than simply the core problem that you are treating. My next question is that what portions of our patients generally fail the original treatment, and may need to go to the second-line therapies? Estimates vary, but a considerable patients require second-line therapies due to insufficient symptom control or side effects. I'm a tertiary referral center, so I'm seeing generally, the more complicated and complex patients that my gastroenterology colleagues are struggling to manage on their own. Occasionally, you know, the endocrinologist will send a patient over to me who hasn't been under the care of a gastroenterologist separately. I'm biased in the sense that patients I'm seeing tend to be on the more complicated spectrum. If we're speaking more generally as a, as a general rule, second-line therapies are going to be coming into play for a considerable proportion of these patients. Would that be the case that, when giving you in the academic settings and the tertiary referring centers, you mentioned that, you're getting more severe patients more often, you've been presumably seeing the benefits of, you know, being able to bypass the GI tract for, treatments that will be, will have a significant impact? you know, compared to other situations, you know, community settings? Absolutely. You know, it's my job to be aware of the latest treatments, the latest data. It's my job to be at the spear tip. I think, you know, that's been one of the hard things with GIMOTI in that it was, it came out in the middle of COVID, where, you know, there was a lot of distractions in healthcare. For me, though, that's my job. I need to know everything. I need to know the latest, absolutely, it's a tool that we've been leveraging from the outset for our patients in my motility practice. Do you have any patient that experience a symptom improvements when they are in the hospital using the IV metoclopramide, once they are continue, you know, is discharged and the oral drugs would not be active or effective in those situations? Well, yeah. One of the things that is done for gastroparesis patients who come into the emergency room or admitted to the hospital, the main thing that's done is simply placing an IV and bypassing the stomach. I mean, that's the main intervention that can be offered versus in the outpatient realm. Put another way, bypassing the stomach is the main thing that's done. Absolutely, we see patients who do well as soon as the stomach is bypassed, and then if they're put back on a oral regimen, they don't have as good symptom control. Naturally, these are situations where an intranasal formulation seems like a great choice. Generally, if I conclude that to bypass the stomach, over a longer period of time, both in hospital and out of the hospital, could be a, at least a solution for some patients, otherwise they may not been able to have the benefits, leave the hospital after they leave the hospital. Well, absolutely. Now with the data that I presented, we can say conclusively, it makes a difference in terms of reducing Healthcare Resource Utilization. Before, that was more of a hypothetical question. Yeah, I can now affirmatively and confidently tell you that is very much the case. Okay, great. Maybe one more question here, which is, under what circumstances you might prescribe GIMOTI instead of other medication for treating the gastroparesis patients? I understand there's a number of medication theoretically off-label, but being broadly or frequently prescribed by physicians. Metoclopramide is mentioned in our most recent guideline from the American College of Gastroenterology from 2022. Right. As a valid treatment for gastroparesis. All gastroenterologists should be, you know, held to our guidelines. Metoclopramide is once again affirmed as an appropriate treatment. Within metoclopramide, nasal metoclopramide has all the advantages we've discussed, bypassing the stomach and being present within minutes, the GIMOTI jump. In my experience, my preference would be to discuss this as an option with any patient I meet who is on oral metoclopramide or who is embarking on a treatment for diabetic gastroparesis as a new diagnosis. Okay, great. Certainly in the academic settings, you have the latest and the most updated information's to make, for making decisions. Given GIMOTI was launched in a challenging time initially, so what's your in terms of the buy-in by the physician for using a GIMOTI, is it to your knowledge, is there a difference between the academic setting and the community settings? You know, just a few days ago, this past weekend, I gave a talk on gastroparesis to Southern California GI Society, which is hundreds of mostly community gastroenterologists in Southern California. You know, I asked how many had heard of GIMOTI and how many had prescriber experience. I think just this is a new medication that was Launched in the midst of COVID, and so there weren't a ton of people who were aware of it. Once you hear how it works, it's not complicated to understand its advantage over oral metoclopramide. Immediately after I went through asking how many people had heard of this or prescribed it, then I, you know, get a lot of the follow-up questions, "Well, tell me more. How do I prescribe it?" There's this disconnect between awareness and then, "Wow, okay, I want to start using this." That's very real. You know, COVID was a challenge. COVID took over everything. COVID shut down our colonoscopies and endoscopies, and it's certainly devoured everything in sight. Now that hopefully a lot of that is in our past, useful tools such as GIMOTI hopefully will emerge. I don't expect there to be any significant concerns because it's a natural choice over oral metoclopramide based on its mechanism of action. Once providers get their hands on it and get the feedback from patients reporting that reduction in nausea within minutes, that will validate everything about this drug. Okay, great. That's again, very, very helpful in terms of we understand this for the overall landscape at the moment. I assume in your experience, when you prescribe GIMOTI, I assume there's also patient will request to refills. What sort of feedback you might get from patient, why they choose to do so? What are the general characteristics of the patient will request for that if you know, being able to summarize or group them? We know patients are gonna refill their prescriptions. Right. If they find the treatment effective in controlling their symptoms and manageable in terms of side effects. I get a lot of refill requests for GIMOTI, so that does to me tell me that it's working. Patients are happy. The symptom that I'm most dialed in is the nausea reduction and the vomiting reduction. I'm also taking a look at in each visit we go through and see, Well, how many emergency department visits have you had since I last saw you? Were you ever admitted to the hospital? Because with this patient population, it's the scope and scale of the symptom burden is so high. There's this enormous healthcare resource utilization component. I'm also looking to make sure, "Oh, wow, you haven't had to visit the ED since I last saw you." These are other things that we talk about, and we hear from our patients. Okay, great. As you mentioned earlier, GIMOTI has been listed as potential as to be used as a first-line treatment options. The question here is that do you envision the circumstances for using GIMOTI as first-line could increase? If so, what type of the gastric presentation initially probably will be suitable to fit the bill? I think GIMOTI might be used as a first-line therapy in cases where patients have difficulty with oral medications due to severe nausea or vomiting, or if there are other contraindications to oral medications. You know, some patients have difficulty swallowing pills. It's difficult, and so a nasal spray would also be attractive to that population. Okay, great. Another question actually is data came out a year earlier, which indicating that the side effect or of metoclopramide, tardive dyskinesia, actually is much lower than initially anticipated or expected. The more recent data even suggests there's only 0.1% of these incidents. To your knowledge, does this information broadly disseminated to the physicians at the moment? Secondly, does that also potentially changing the prescription pattern, the pattern of prescription for metoclopramide-based medications? You know, tardive dyskinesia, this involuntary muscle movement, is an important side effect for patients and providers. A lower incidence rate of tardive dyskinesia would certainly increase physicians' comfort in prescribing metoclopramide. The data, I think, if it is hopefully published in a full journal article, this latest data you're referencing, I think that would be very important in providing reassurance to patients and providers regarding this concerning side effect of involuntary muscle movements. Okay. One more practical, questions for a lot of physicians and patients, which is on the reimbursement side. In general, do you need to have a prior authorization before prescribing GIMOTI? Are the sort of reimbursement from the private versus the public side, any difference, at least in your experience? Reimbursement, prior authorization processes for GIMOTI vary depending on specific insurance plan, provider, and region. Blissfully, in my practice, I am somewhat removed from that. We have, you know, dedicated personnel who work on prior authorizations and insulate us as the healthcare providers just to make medical decisions. Occasionally, they'll ask me to send a journal article or two on the efficacy of a particular drug. GIMOTI, like many drugs in the gastroenterology space, goes through a particular specialty pharmacy. In the real world, I have a list of drugs I know have to go to a particular specialty pharmacy. I have that on my phone. I pull it up. In our electronic health record, I select that one pharmacy, send it there, copy our prior auth team so that they're aware. I've not had any substantial problems prescribing GIMOTI. Okay, great. That's very important, I guess, for a lot of folks as well. Maybe the last question here before I open up for, you know, Q&A, my audience, is that, is there any other additional comment you may have regarding GIMOTI in treating gastroparesis? I would say, you know, a few things to think about. One, metoclopramide is unique for gastroparesis. We all recognize it works peripherally and centrally. That's a really important point because it speeds up the stomach and also works on the brain to reduce symptoms. Very unique. We have other drugs that just work on the brain. We have other drugs that just speed up the stomach. The dual action of metoclopramide is uniquely well suited for this disease. Secondly, the GIMOTI jump is real. It makes sense. It's not complicated for patients or healthcare providers to understand. When I talk about it, immediately the light goes on. Certain drugs, I've got to do a lot of hand-waving, we need complicated slides. This one really is not complicated. As gastroenterologists, we understand the stomach can turn into a morass, a swamp, a waiting room. We go in there are huge chunks of what we call bezoars or collections of material and pills and capsules. We absolutely know why a patient's blood sugar control has been so difficult to manage with oral agents, because the timing of those agents getting absorbed is quite variable. GIMOTI is a really elegant solution for that by just bypassing the stomach. The nose is like a big blood vessel, it takes full advantage of that. Those are the two things. Metoclopramide's a nice fit for the disease. GIMOTI is jumps into the bloodstream. That's the story of this drug. Okay, great. That's very, very helpful, and I really appreciate it. First of all, I'd just like to see, is there any questions from audience want to put it out here? I'm just checking on that, maybe give a half minute to see any things jump in. Okay, this is my half minute's time clock. Maybe I have one more question here before maybe we can wrap it up, which is an interesting question I thought about, which is that, I mean, the oral metoclopramide have the problem sometimes that the drug never get to the site, and therefore, you know, you have problems to show the effectiveness. Now, you have way, you know, bypass that. Obviously, IV could bypass that as well. My question here is: Is there a metoclopramide drug resistance issue, or have we identified anything like that, at this moment, or that's still something to be researched on? A metoclopramide drug resistance. That's an interesting terminology. Sort of resistance we generally think of with antibiotics, anti-infective agents. Generally, I would say the limitation with metoclopramide concerns side effects. Certainly, there are patients who don't tolerate it. That's big, the biggest limitation, is side effect tolerance. I wouldn't say that there's any resistance. It's not, there isn't an immunogenicity problem, there isn't tolerance, or tachyphylaxis that we see with other agents. Okay, great. That actually is very good to know because that seems to provide a metoclopramide-based medication. I mean, there's a strong incentive to prescribe this drug because once you've been able to deliver to the site continuously and that they should be effective and that will be very helpful for the patient across the board. This, at this point, we really appreciate your participation and give us great insight of both treating the gastroparesis as well as the GIMOTI information or details or benefits that will be the first time again in a very controlled and unbiased manner to present it to all of us. I thank you for participating, and thanks for all the audience to listening to this story. If you have additional questions, you can send it to us or to the company. I think they will be happy to address that. Again, thanks a lot and have a good, I guess, afternoon, I guess. Good to be with you. Take care. Bye-bye. Bye-bye.