TD Cowen Global Healthcare Conference, 46th Annual. I'm Dan Brennan, I follow Tools and Diagnostics. Really pleased to be joined here on stage with me, the management team of GRAIL. To my immediate right, we have Bob Ragusa, who's CEO, and to his right, we have Aaron Freidin, who's the CFO. We just launched on GRAIL recently, we're really excited. This is our first point of, you know, hosting them in a conference. Hopefully, there'll be many more. Gentlemen, thanks for coming. Yeah, thanks for having us. Terrific. Yeah, I thought before diving into questions, maybe most people are probably familiar with GRAIL, but maybe some aren't. Maybe Bob or Aaron, do you want to spend a minute or two just kinda giving a quick profile of GRAIL and you know, if you want to give maybe a little bit of an update. Obviously, you had the NHS-Galleri study we'll dig in, but just kinda how you would frame things, and then we'll go from there. Sure. Well, first, thanks, Dan, for having us here. Thanks to you and the Cowen team. This is always one of the premier conferences, so it's great to be here again. Yeah, so at GRAIL, you know, our mission is to detect cancer early. We've been, you know, commercial with the test for about five years and have sold around right around a half million tests at this point, done, you know, hundreds of thousands of also, you know, research tests in that same period of time. We recently released top-line results from our NHS-Galleri trial that you mentioned. There, you know, we think it's an incredibly rich data set. Within that though, we, you know, the primary endpoint of a reduction of the combined stage III and stage IV, we did not see in the study. We did note that we saw it trending towards that. It was also a relatively short trial for screening. Within that, we also saw some incredibly strong stage IV cancer, so about a 20% reduction in stage IV cancer. Increase in stage I and II Cancer Detectio n. We saw a 4 x improvement in detection rate compared to standard-of-care. When you take the arm with Galleri plus standard-of-care compared to just standard-of-care alone, there's a 4x increase. We also saw a substantial decrease in the number of emergency presentations. These are people showing up in emergency rooms with, you know, really dire straits, which I guess about 20% in the U.S., about 20% of cancers are found that way. We saw a substantial reduction in the NHS-Galleri trial. We think there's a great body of evidence here for both regulators and payers, who are gonna look at the data. From an FDA perspective, you know, we don't think the FDA, we know the FDA does not have a stage III or IV as an endpoint. They're gonna be looking primarily at performance and safety profile of the product. We think, you know, again, demonstrating across PATHFINDER 2 and NHS-Galleri, so 35,000 and 140,000 people where the performance and safety is shown out, you know, shown again to continue to replicate well. We feel, you know, feel good about that. Right. Right. Base case, which you said on the recent Q4 call, and obviously now is base case is no real change in the confidence towards FDA and then following Medicare coverage from the data. Right. Right. That's correct. Maybe with that then, you know, the primary endpoint, as you mentioned, was stage III, stage IV versus with the stage IV benefit you saw. What is it about the trial design? Why not have set up the trial design on stage IV if that's what you're highlighting as meaningfully important and FDA and Medicare could accept that as opposed to this stage III, stage IV? In the early, you know, roll the clock back about seven years when we were designing the study, first we were looking for where could we do the study. One of the great things about the NHS is their ability to enroll trials quickly. With the NHS-Galleri trial, we were able to enroll 140,000 people in about 10.5 months. Pretty much unheard of in the U.S. You know, in working with the NHS, in their long range plan, they had a lot of emphasis towards stage III and IV at the time. Again, this is seven years ago. That's where the endpoint came from. You know, if you fast-forward though over the past seven years, what's changed? In that same timeframe, there's been enormous progress on the pharma side on stage III treatments. Across a number of cancers, you see lots of improvement in stage III. You know, so much so that people now kind of talk about a mortality cliff between stage III and stage IV cancer. When we were looking at the REACH study, so we worked with the FDA and CMS on our REACH study, so that's 50,000 people in the Medicare population over three years. When we set the primary endpoint for that study, that would be a stage IV reduction. The world's kind of shifting towards that and, you know, we have with it. Okay. So, so maybe, one more question. We'll have a lot more questions. We were under the presumption that the trial was powered for a 15% reduction in stage III, stage IV, and maybe the range was like 12 at the low end and, you know, 15 at the midpoint. You had a lot of benefits, 4x increase, 20% greater reduction in stage IV, and then you had, you know, increase in stage I, stag e II. It was really that stage III that hurt you. I guess we'll find out at ASCO. Is the expectation that you could have been very close to that statistically significant? Would you be meaningfully below that? I guess will that. You know, how much will that matter if you're sitting at six or eight or 10 or 12, being close or not close, do you think, ultimately maybe towards more Medicare than FDA, it sounds like? Yeah. You know, one of the things we decided, you know, because we want to present the data at ASCO, that we're gonna have to stick to really, you know, relatively high level results to preserve that. We're not gonna comment on deeper, you know, deeper detail on it. You know, clearly, when we get to ASCO, we're gonna present a lot of detail that people will be able to see and looking forward to that. Okay. Well, maybe in terms of the label, you know, we mentioned on the way up here, like, the unscreened cancers obviously is where there's a huge unmet need, right? Pancreatic, esophageal, ovarian, gastric, all these head and neck, and then you've got, what, four or five on-label screening cancers between, you know, lung and colon and breast. I know your pitch at GRAIL's always been like, this is gonna be a all cancer. It's not gonna be individual cancers, the way you've set up the business and the kinda trial. That said, I think now with this kind of NHS-Galleri study, like, do you think that changes in terms of a pan-cancer label that the FDA would apply if they were to approve it? Do you think now there's gonna be more of a focus on looking individual cancers and identifying maybe those where there was a benefit in stage, you know, four reduction, and you've got that benefit where that cliff exists, so you can actually treat and have an impact? Yeah. you know, we've been working with the FDA, since, you know, 2018 with Breakthrough designation, we've had a lot of conversations with them, and including our most recent, you know, the actual filing in late January of, you know, for our PMA. One of the things during that time is to really educate them on how the test works. The way the test works is looking for a pan-cancer signal, so a shared cancer signal across many, many cancers. They recognize that. In addition, with the performance data consistently showing a very high positive predictive value, you know, if we get a positive signal, then a clinician knows there's a really high likelihood that the person in front of them actually has cancer. Given that, the FDA, you know, in our discussions said regardless of how the label comes out, we'll be able to report out on all cancers. We think commercially, you know, regardless of how the label turns out, we think we'll still be in good shape because we'll be able to report out on any of the cancers we find. Would that then, for instance, if you had a label for these six cancers, and then you had another 44 behind it on page two, I guess, would that influence kind of the uptake or to influence payment rates? You feel as long as you have all 50 in there, then it's kind of your strategy as you've set it up is intact? Yeah. I think it's intact. I think, you know, from a clinician's viewpoint, I don't think they're gonna distinguish highly between the two. You know, it's a multi-cancer test. What they actually do at the end is gonna be very similar. Yeah. I mean, the standard-of-care screening in the U.S. finds 16% of cancers right now. If we're finding 3x, 4 x that, the person doesn't know what cancer they have when they're walking in to take the test. Right. As long as we can return all of our results, physicians can work them up. Right. Okay. Like, will we see at ASCO any individual cancer performance at all so that we can actually look at and say, "Here are the ones where..." Because you had the CCGA-3 and the PATHFINDER 2. You just gave the overall sensitivity on those 12 pre-specified, but we didn't get to see. We've tried to do our own math. I'm sure many investors have tried to do their own math, but will there be some individual cancer performance at ASCO? Yeah. The ASCO readout will be, you know, quite detailed. You know, as you know, the way the format is, the main session's relatively short, we'll dive through a lot of detail there. We'll also try to have some auxiliary sessions so people can do a next level deeper dive. Beyond that, we plan on publishing the data as well. We think it's an incredibly rich data set, and the more people are able to look at it and study it, they'll, you know, kinda be in our camp in terms of knowing there's a lot of goodness for clinical utility in there. I know with the administration change, I know there's been changes within FDA. I don't know the people that were reviewing your file originally, I think they're not there, so they've changed out. I guess when you file the final element of the PMA, has there been any at all change in discussion among the new people that are there now versus the old people when you first started? Yes. We've submitted the full PMA package. We did that back in January. We've had a consistent relationship with the review division. That's been working really well s ince Breakthrough in 2018. If, if for whatever reason, let's say you get FDA approval, great, but it is a limited label. Let's say for whatever reason, even though they've confirmed to you they're gonna allow you to report out the other ones in the back, but for some reason that doesn't happen. Maybe the new reviewers, whatever the case. Does that change? Beause in our opinion, like, you know, William and I have thought about this when we were doing our model. It's like if we're catching the tough cancers where there's no available treatment, I still think you're going to the doctor to get that test. Yeah, it would be great to have more cancers, but, like, how would that change? Let's say you had six cancers versus 50, right? Obviously it doesn't sound great, but in the end, like, six cancers is still there's no other route. How would that change your go-to-market, the opportunity, do you think? Yeah. I mean, so far, again, we just don't see getting down that pathway. We've, you know, had so many multiple discussions that we just don't see that as a strong likelihood. Again, you know, that's gonna You know, in order to get there, they would have to say, "We have a high certainty that this person has cancer, and we're not gonna let you tell them. Mm-hmm. You know, anything's possible, as you say, but we haven't really thought too much down that pathway. Well, from a commercial approach, as I was saying, you know, it's six cancers that you don't know you have, and it's probably gonna increase the likelihood of finding cancer compared to the standard-of-care. Right. I still think it's a test people take, and still gets reimbursed. Maybe one more on that, on that topic, cause, like, lung and CRC, you're obviously on the label, and they've been, like, the highest. I mean, those are the highest incident. Breast is higher, your performance, cause it's hormonal, I don't think is great in breast. On lung and CRC, your performance, it looks good at the high specificity. Lung to date, like, there's really it's only CT scan in high-risk individuals. You guys are going in for an. I mean, I know I think you talk about it's high risk, it's over 50. It's not a 20-year smoker life. Mm-hmm. It's different. This would be like, you know, you've got other companies going after lungs. This would be a big one for lung and for CRC, where the FDA, where CMS set, like, a certain parameters around blood tests. You've gotten confident on lung and CRC, these really big indications where there are approved screening methods that there's no minimum that you need to meet there for FDA in order for them to grant that approval, I guess? What we're looking at is, again, all cancers, as Bob said, right? Those are individual cancer screens with their own metrics and reimbursement paths and so on. MCED legislation gave CMS the authority to reimburse for MCEDs. They're gonna do that at, you know, the Cologuard price, $500 or so. The FDA did say that in their AdCom that they're gonna look at aggregate cancers, the total cancers found. Again, we don't think it's gonna have much relevance on the CRC and lung reimbursement or performance for the MCED test. Okay. Okay. Medicare, we know under MCED is based on, you know, it needs FDA approval. In terms of FDA, let's say they give pan cancer terrific. FDA gives six cancers with the other 44 in the back. Does that change at all how Medicare kind of reimburses the test, do you think, if they decide to reimbursement? I think the reimbursement from CMS has come down to their national coverage decision, and they're gonna look at clinical utility. Mm-hmm. They'll look at stage shift, from NHS, from the REACH study. They'll look at real-world evidence. They'll look at, you know, around, you know, Cancer Detection rate, how many cancers we find, so on. They'll look and so on to determine that reimbursement rate. Mm-hmm. They've historically looked at mortality, which, you know, this is. We don't have mortality study. We're gonna have mortality readouts as part of NHS over the next two to six years. You know, relating stage shift mortality, there's a growing body of evidence around. That's really, I think, they're gonna look at those clinical utility metrics around stage shift and around Cancer Detection. How much are you increasing the screening detection? Like the MCED legislation says FDA approval, Medicare has a pathway. Do you think then are they like NHS Galleri? We assume they would look at that, but there are some people who feel, "No, it's FDA approved," and they're just gonna kinda stamp it and like kind of a, you know, reimbursement. Do you think NHS Galleri will be a prime study that Medicare will evaluate when they make their decision? Yeah. Again, I think you'll see at ASCO the body of evidence and the data there is, you know, unprecedented. You know, It was a very well done study. Unfortunately didn't meet the primary endpoint of stage III and IV. That doesn't mean that stage IV isn't significant. That doesn't mean it isn't trending to III and IV. There's all sorts of things you could extrapolate from it. Is there a middle ground for Medicare where you'd get coverage with evidence development? We've heard that from some experts. Just wondering, you know, where basically they say, "We'll approve you, but we're gonna, like, have a certain go forward study, and we want you to generate clinical data in this population, and then we'll cover it for that population." Is that something you guys think is a potential route if Medicare does decide to cover? When, you know, when we get FDA approval, you know, Again, we applied in January of this year. It's typically about a year process, somewhere first half of, you know, next year when we get FDA approval, we will, you know, we'll apply for the national coverage determination. I think it's premature to figure, you know, think about, you know, how are they gonna come out on that. The one thing we do know is we've already had discussions with the FDA and CMS in the launch of the REACH study. The REACH study is being done in the Medicare population, kind of to already, you know, preempt that. We're looking at 50,000 people in the Medicare population where CMS is already paying for the tests and the workups. We think, you know, we're already on that pathway where we'll have evidence generation to be able to see in their own population. Okay. Okay. Thinking about commercial USPSTF, I think you've said if you get FDA Medicare, you're gonna file, you know, you think you'll be included in guidelines. Has there been anything out regarding any modeling studies or how USPSTF would consider this if there's even a body to meet right now, right, obviously? Yeah. You know, obviously, you know, Guardant's looking for that with Shield, and there's a lot of debate on whether or not that test would actually clear the bar. Yeah. You know, again, if you step back, we're really looking to. You know, this test has been designed for population scale. We're looking for how do we get broad access. Upon FDA approval, we'll go really in a dual pathway. We're gonna go for a national coverage determination with CMS, and we'll go down the USPSTF pathway. We kind of have two shots on goal for that, and we think they're both viable pathways. As you mentioned, USPSTF, the timeline's more uncertain than that but t hey're both viable pathways for long term. Also, I mean, this will be the first time they'll be looking at an MCED. Right. Who knows what, where the bar will be and what they're gonna draw. We've been doing this for quite a while. All of our studies with have been done under IDE with the FDA, so we've kinda showing people where the bar is and so on. I think as Bob said, it's too early to. We don't know what they're gonna want. Right. There hasn't been... Bec ause like with colon cancer, they'll look at the benefits to harm with life years gained versus unnecessary colonoscopies. Have you seen, has there been any conversation you've had or anything of the sort that would dictate how they would kind of contemplate the benefit we get, life years gained maybe, but how would they benefit, you know, how would they look at the harms or maybe there's another matrix that they would look at, or maybe we just don't know? I think that's a great question. Yeah. We just don't know. Yeah. I mean, the harms, if you look at the FDA side of it, have been pretty clear, and we've, you know, looked at them in our studies. you know, so one is do you continue to do your standard-of-care screening? Beause we've always said, you know, Galleri is a complement to standard-of-care screening, and that's why we compare the two. It turns out in the studies that people follow, you know, do even better following their standard-of-car e screening. They don't say, "Oh, I'm not gonna go do those," when they take the test. you know, they look at, you know, false positives, any harms, and we've had no serious adverse events across these large studies. There's another important, you know, safety factor, and we have a very low false positive rate. Even with anxiety, you know, we looked at that, and we studied that along the way, and it's not any different than other screening tests. You know, it's interesting in the early, you know, the PATHFINDER data, when you even look at people with false positives, they actually had, you know, very high satisfaction scores when they came out of it because, you know, people just understand the value of detecting cancer early. Okay. Okay. Maybe just thinking about the self-pay market for a bit. Like, have you guys sized that market? I mean, we've tried to look at individuals making over 200,000 in the U.S. Then we took a number OUS and put a $700 price on it. We came out with $21 billion. How have you sized the self-pay market? Yeah. It's something we've been looking at sizing since we started the company. It's big. We've never come out and said a number because there can be so much overlap in those populations. Mm-hmm. I mean, everyone who has a concierge doctor probably also has a digital health platform that, you know, they might also just have a brick-and-mortar PCP. There's a lot of people there. I think what we've demonstrated since we launched in 2021 is that market's bigger than people might have thought it would be for a self-pay, non-reimbursed self-pay test in NMSAT. Other evidence along the lines, like our retest rate now is over 30%, again, for an out-of-pocket test. So that's... Repeat test, sorry. Yeah. Repeat test, right. Yeah, I think we're excited about the size of it, and we think it's continued to grow with what's going on in digital consumer health right now. We've never come out and sized it. Right. You know, what Aaron Freidin mentioned on the repeat test rate I think is really important. You know, our understanding is, a Cologuard test has somewhere in the 20 percentile repeat test rate for a reimbursed test that's been FDA approved for 12 years. We think the fact that you can have those kind of repeat levels in a self-pay, non-reimbursed test that's not yet FDA approved, we think shows just again the intrinsic value that people place on tests like that. Maybe just one more back to Medicare. If for whatever reason Medicare decided, and it's just Galleri failed, you've got all these great stage IV endpoints, and you have the stage I, stage II, but we're gonna go by the study, and we're gonna say, "Nope, we're not gonna give you approval right now." Like, the self-pay market is still a really large market. Obviously, cutting off Medicare would not be ideal at this point, but, how would it like, how would it impact what you do since there is still arguably maybe a $20 billion plus market still sitting out there? Yeah. I think there's, you know, a number of pathways. As I mentioned, there's USPSTF pathway, which, you know, is just longer term, but we would certainly go for that. Then internationally, you know, there's a lot of the markets internationally that we've just started to broach. You know, we had the announcement with, you know, the announcement with Samsung that we had in the fall. That's in their CEPHEUS review right now. But, you know, we would push, especially with the NHS data, we think that's rich data set that the rest of the world would find a lot of value in. I think prior to having that data set, if we went to another country, they'd, you know, likely want to do another large study. What we're showing because the data in the NHS-Galleri was highly diverse, as well as the PATHFINDER 2 data is highly diverse, and we'll be able to compare those two data sets when we get to the detail and show that the test is, you know, just representative or independent of ethnicity and independent of socioeconomic status. I think we'll have a lot of good data so that when we go to the next country, we won't have to repeat a large study. You know, you might have to do a smaller study in their particular population, but those large studies should be behind this. What's the potential for NHS? You know, the next phase was that they could move on to this really big, like, next phase of testing. There was 1 million patients. I mean, William would know. I should know that off the top of my head. The fact that the trial failed, but all these positive endpoints, how do you think about them moving to the next stage? Yeah. Within it, they had multiple endpoints, you know, from a contractual standpoint. We're in that, in that range where we'll have discussions with them about what the next step forward is. We anticipate those won't, you know, won't start until we're able to really go through the whole NHS data with them. You know, still a few months away from that. You know, we'll have a discussion. There's a lot of you know, a lot of different ways they could proceed from this point. Maybe one more back to the data. Like, by getting another year, you're not testing another year, right? You're just waiting another year. What would be the hope that you get more of these cancers to appear in the control arm, basically? If you think about it, we've effectively Because we're screening and we see in the, you know, in the prevalent round, the theory is always you're gonna pull a lot more cancers out, and we'll see that in a year, you know, the second and third year. The control arm hasn't had those cancers actually show up yet because they're not being screened for. The hope would be that in the control arm, you'd see more cancer showing up there. When you do the comparison, you'll show more of a reduction in the intervention arm. Maybe one more there. Like, I know you talked about it on the call, but mechanistically, is there a reason why there was such a good reduction in stage IV and not stage III? Is there something about the English population, dwell times, anything that you've been able to deduce? I'm sure you've thought a lot about it a lot since you set up the study and now had some time. Yeah. I mean, not yet. We'll go through again, more detail at ASCO with that. I think, you know, one of the things of note is the NHS-Galleri study for a screening study was relatively short. It was three rounds with one year of follow-up. You know, many of these studies go one decade, the protocol is go one decade and then wait, you know, even beyond that protocol time till, so you can show, you know, the reduction that you're looking for. You know, we did three rounds and with 1 year of follow-up. It's, in screening terms, it's relatively short. Yeah. No. We spoke to a couple of modelers that said the same thing. Maybe back to that trial design, I guess you said NHS wanted to enroll it fast, but, like, who made the decision on the three years? Yeah. That was, you know, a joint decision. You know, obviously the NHS was pushing that again based on their long-term plan. Yeah, They laid out, like, within 10 years, they wanted to reduce, like, cancer mortality by X. Mm-hmm. This was one of their shots at goal on that. Okay, the concierge medic, you know, back to self-pay would mean, you know, their stats online, it looks like it's around $5 million or so U.S. individuals that are enrolled today. Is that your biggest market today? Or, I mean, you talk about self, you know, kinda self-insured employers. You've got some, you know, veterans. You've got a lot of different buckets in the self-pay. Within self-pay, just trying to isolate that concierge market. Yeah. We started there, but now it's a smaller portion of the business. Like, self-pay, brick and mortar physician's offices are the majority of the business. Really? Yeah. Mm-hmm. Yeah. It's been a great, really a great transition. You think about, you know, the obvious spot is concierge doctors because of that market, and we have had strong penetration there. Again, I think it's just the power of the test that it's appealing to people that were way outside the concierge market. Mm-hmm. When we went to, you know, and talk with Rush, for example, in the Chicago area, we, you know, they introduced the test into their population, and they had a number of slots that they had, and they filled them up within a couple of days out several months for appointments, so. Right. The, you know, the popular appeal as it gets more and more well known is pretty impressive. Is that a big, like, Intermountain, Mayo, Rush? I know they're all doing it. Mm-hmm. Yeah. Yeah, because I mean, we would think concierge medicine is just a no-brainer. You've got 5 million people. Why wouldn't 80% of them? Yeah Galleri Test? You're nowhere near that penetration. Yeah. Right. You mean, you can't be, otherwise the numbers would be a lot higher. Yeah. Um- Yeah. We've seen where there's a health system that's adopted championing, then that has a halo effect to physicians' offices, other practices, other health systems in that area. Mm-hmm. You can also see in Dana-Farber and Mayo, where they've published their own data on it. When it's in a system's hands that actually has experience with the test, their PPVs are 70%-80%. Mm-hmm Because they don't stop looking. They've a ton of conviction to go find a cancer. Health systems add a ton of value. How about between, like, Function and Everlywell and Hims & Hers is new, but Function, I do Function, so it's right that. Actually, Function says over 20 years old. You know, when you go through it. Yeah. You get to that page that says, "If you're over 20, you can take them." Like, I thought it was indicated over 50, so maybe. It's if you think about it as the risk of cancer of a 50-year-old. Yeah. If you're under 50, but you smoked, or you had cancer, or you have a mutation or a family history... Right You've got about the same risk. Got it. Between those channels, Hims & Hers is new. Maybe just hit on that one. They've had over 2 million subscribers. Kinda what could that do? Yeah. Early game there. Right? We just launched. We'll see how, you know, Hims & Hers, all these other folks who might have been selling GLP-1s or more a weekly type, excuse me, subscription versus a once a year test. We'll see how that uptake goes ov er time. We're optimistic about it. It's a very capital efficient way for us to grow f rom a marketing perspective, from a salespeople perspective, and so on. We're optimistic. Function have been and Everlywell have been great partners. I think we're seeing a lot more uptake and growth in that, in that digital health longevity space. We expect to grow as they grow. Yeah. What's nice there is you're in a market where people have already decided that they're gonna pay- Yeah F or some of their healthcare themselves out of pocket, the Galleri Test fits in, you know, in the current state, like, really well with that right now. Maybe just on your long-term gross margin, 50%-60%. I think you've got the 7% royalty beginning to Illumina this year, end of the year. Your current COGS, I think, are what? $360-$370. You know, they're gonna get to an ex Illumina royalty cost, I guess, of, like, close to $200 at an ASP of $500. Just what's that pathway on the COGS reduction? A lot of it's volume driven. We've got a platform that can run just over 1 million samples. The more samples we put on it will drive toward those costs. It's essentially fixed cost reductions. We've got future plans to innovate to push the cost down further. That's, that's the path to get there. Mm-hmm. Give me volume. Got it. Maybe, yeah, one on competition, and then we'll end it. You guys are certainly generated by far the most clinical evidence. It's, it's an attractive market, so, you know, Exact Sciences there with Abbott. You've got, you know, Freenome and Guardant taking a different tact. I don't know. When you think about your performance of your tests, like how do you think five years from now, what do you think the field looks like, and have you evolved your assay to, like, a second-gen assay by then? Yeah. First of all, I, we think it's actually really good to have competition. What we're noticing out in the field is that more and more people, you know, more and more customers are interested in MCED. There's a lot more people talking positively about it. Just a couple of years back, that wasn't the case. People, you know, a lot of the same people were neutral at best on the field. We think that helps bring a lot of people in. You know, we've clearly done a lot of studies and set a really high bar in the field. We think that to launch an MCED test, given the importance of it, and the fact that we're going through a PMA process, that people should be doing prospective, interventional trials in the intended use population. We think that's a critical way for clinical validation of an MCED. You know, in that, we think we've set the bar really high for the competition, again, with the studies we've done, with the performance we've demonstrated. Okay. Great. Well, we're out of time. Gentlemen, thank you for being here, bearing with our questions. Hopefully, the audience benefited, and look forward to a, you know, fruitful.