All righty, let's get started. Welcome everyone to the 40th annual J.P. Morgan Healthcare Conference. My name's Anupam Rama. I'm one of the Senior Biotech Analysts here at JP Morgan. I'm joined by my squad, Priyanka Grover, Lyra Hall, Malcolm Kuno. Our next presenting company is Syndax, and presenting on behalf of the company, we have CEO Michael Metzger. Michael?
Thank you, Anupam. Thank you, JP Morgan, for having us to this year's conference. It's always a pleasure to present to all, all of you today and give you an update on our progress. It's been a really very exciting year. As Anupam said, I'm Michael Metzger, I'm the CEO of the company. So this is our forward-looking disclosure, as others, we are making forward-looking statements today. I ask you to refer to our SEC documents for further information related to forward-looking statements. So I'll start off today talking a little bit about our two programs, actually, a lot about our two programs. We are, as many of you know, an oncology company with two near-term commercial heme assets, so our focus is on-- is, is certainly in heme.
We have two potentially best-in-class, first-in-class, and best-in-class hematology assets. The first is revumenib. It's a novel menin inhibitor targeting KMT2A acute leukemia, as well as NPM1 mutant acute leukemia. Second drug is axatilimab, which is a CSF-1R antibody targeting chronic graft-versus-host disease. Both were highlighted this year at ASH, so we had a very good ASH meeting this year with both the plenary for axatilimab and the late breaker for revumenib. It's also an exciting time for the company because we have two pivotal programs that are going to registration. We recently submitted the first application NDA for KMT2A acute leukemia under RTOR, Real-Time Oncology Review. The opportunity, the first opportunity for indication there in KMT2A and NPM1, is quite large.
We think it approaches $2 billion, and we'll say more about that in a little bit. In terms of axatilimab, we also submitted a BLA with our partner, Incyte, at the end of the year. So two filings at the end of the year on top of one another, quite, quite a feat for a small company. That also has axatilimab has a large market opportunity in third-line plus chronic graft-versus-host disease, with opportunity for expansion. So both drugs have opportunity for expansion, but their initial indications, we think, are quite significant. Both of these programs are franchises with long exclusivity out to 2040, so they're well, well-protected assets, and the company is very well capitalized.
We recently raised $258 million net in an offering at the end of the year, and I'll say more about that, but it does give us cash runway through 2026. So a very exciting time for the company as we progress to a commercial stage organization. So first, I'm gonna talk a little bit about revumenib. It's our menin inhibitor, as mentioned. The first approval will be in adult and pediatric relapsed/refractory KMT2A acute leukemia in 2024, and we do see these opportunities for expansion. So a little bit about the market to start. This is the-- this will be the first drug to address both KMT2A and NPM1 disease. They represent about 40% of AML and ALL. On the left, KMT2A is about 10% of AML and ALL, probably the worst prognosis for AML and ALL patients.
They have an overall survival of about less than three months in the third-line setting. So it's a very, very difficult diagnosis, and today there's no treatment that really works for these patients. And then for NPM1, it represents about 30% of AML. These patients have about a 50%, 50% survival rate at five years in the early settings, but you have in the relapsed/refractory setting, very poor prognosis as well. Again, it's the most frequent genetic alteration. The good news is that revumenib will represent the first drug to address both populations. So what are physicians looking for in a new medicine to treat these patients?
They're looking for a drug that can get their patients to deep, durable responses, MRD negative responses, get rid of the tumor burden, and then be able to put patients back on drug in the post-transplant maintenance setting. They have to deliver this with safety and tolerability that is meaningful to these patients as well. And now we know, based on data that we have, as both monotherapy and in combination, that revumenib can deliver on this. It can deliver monotherapy results for KMT2A and for NPM1. These have been durable, and we've been able to observe the fact that the patients can go back on and stay on drug for months, if not years. We have patients out to almost three years in the post-transplant maintenance setting.
So the results have been very good as a monotherapy, and then recently, we've shown patients have done very well on combinations, specifically ven/aza and ven-HMA, both in the, in the early settings in newly diagnosed patients, as well as in the relapsed/refractory setting. So a very good setup for this, this new offering, potential offering in 2024. So let me tell you a little bit about the, the, pivotal program. It's a very ambitious program. This, this, drug went into patients, and from first patient to, NDA filing, it's less than four years. There aren't a lot of companies that can say that. It's actually about the same amount of time for our axatilimab program as well.
So we've been able to execute very well, and I give that credit to the team for really carrying this program through. We started out with a phase I. 125 patients or thereabouts were dosed to get to an RP2D that covers both KMT2A and NPM1 patients. We moved on and designed a very robust phase II program in three separate cohorts, AUGMENT-101, 2A, 2B, and 2C, all sized at 64 patients with a CR/CRh endpoint.
We had received breakthrough therapy designation from the FDA back after we had presented our phase I data, which resulted in the ability to take the first two cohorts for KMT2A and pool them together and design an interim analysis, which we actually enrolled and then hit the interim analysis, and the trial was stopped early for efficacy back in the fall. We actually top-lined that data in October and under RTOR, which we received, and the agency had invited us into that program. We're able to submit in real time the NDA. So that was what I had mentioned at the end of 2023. We submitted the NDA.
The NPM1 cohort is continuing to enroll, again, 64 patients, and we expect to enroll that at the end of the first quarter, beginning of the second quarter, with data coming at the end of 2024. So very ambitious program. We do expect to have, you know, our last milestone being a filing for NPM1 sometime in 2025. So this is the data that was presented at this year's ASH. This is our pivotal program for KMT2A. I'll just reprise some of the data points that are important here. But I think what comes to mind here is that we have a very compelling profile for a new drug to treat patients who don't have really any failed therapy that works for them. 63%, or about 2/3 of the patients, actually had cleared their tumor burden.
So that is a very impactful number for physicians when they look at, "Okay, well, are my patients going to be impacted by a new drug for their cancer specifically?" And 63% of patients had a response. 23% had a CR/CRh, that's the regulatory endpoint, which met the mark, and we ruled out a lower bound of 10%. So we were able to have a statistically significant result. 70% of the patients were MRD negative, so at the most sensitive measure, we're able to eliminate the tumor and show that it is completely gone. Patients live for, here we've shown overall survival about eight months, which compares to about, as I mentioned earlier, 2.3 months in the third-line setting. So patients are doing very well and able to stay on drug.
We've seen responses across all the major subgroups, and more, very importantly, the favorable safety and tolerability of this drug, very low discontinuation rate in the trial. So patients are able to really benefit and stay on therapy for quite some time. So really what physicians are looking for in this, in this patient population, again, I'm talking about relapsed refractory KMT2A disease. They have been looking for a drug to treat these patients who, by the way, are on average 35 years old. So in our trial, that was the average age. These patients have a lot of living to do, but yet they have this terrible diagnosis. What physicians are looking for, they're looking for a drug that can get their patients to a complete response. As I mentioned, 63%, 2/3 of the patients are getting to a complete response.
They want to drive them to transplant, take them to transplant as quickly as possible, and they want to put them back on drug and maintain them in remission, because they have a very high rate of relapse. You want to keep them in remission on drug for a long period of time. That is the paradigm for KMT2A. Physicians have never had that for these patients, but this is the drug to deliver for them. So we are extremely excited. Physicians are excited about what's possible for this new, for this new medicine. So this is additional data in NPM1 patients. I mentioned KMT2A. This is the other, this is the mutation that makes up 30% of AML. This is our phase I data.
We updated it in the fall of last year, and the reason that it's important is that it's highly consistent with what we're seeing for our KMT2A patients. A high rate of overall response, 50%, 36% CR/CRh rate, which would be the regulatory endpoint in a pivotal trial, very high MRD rate. So these patients are really getting to a deep, durable response. We've seen patients in remission for more than 22 months, a couple years. That is a long time. Again, these are patients who have been, you know, treated with prior therapies. They've had stem cell transplants. They have a very poor prognosis, and yet we're extending their lives for quite some time.
So this is really impactful data for this population, which we're following up with a, as you know, the pivotal trial, which we'll read out at the end of this year. So as I mentioned earlier, we also have combinations now. We can say with some certainty that the ability to treat patients, newly diagnosed patients in the frontline setting, both NPM1 and KMT2A, is possible for revumenib. The standard of care, ven/aza, combined with revumenib, shown here in this BEAT AML trial. This is a cooperative group trial. 13 patients, a 100% response rate, all the patients responded. Almost all of them are MRD negative. There was one patient who actually wasn't tested, so we can't say that they are MRD negative.
But they have a high degree of CR/CRh rate, which adds to what the standard of care, ven/aza, yields in their approval trial. Early days of 13 patients, but I think we're super excited, and the investigators are excited that this is an agent that adds to standard of care from an efficacy standpoint, and importantly, from a safety and tolerability standpoint, doesn't introduce new toxicities. So very promising result. We also saw a combination also at ASH, a ven-HMA combination. This is an all-oral regimen. Dr. Ghayas Issa, MD Anderson, has been running this trial. 9 patients, again, patients who had already received, most of them, venetoclax and stem cell transplants, and here they are, 100% response rate. So we're adding to this regimen and getting very good results.
You're seeing no more toxicity than you're seeing from the doublet alone. So again, this gives us the breadth of opportunity to treat patients, not only in relapsed refractory disease from using a monotherapy of revumenib, but also combining it the way physicians may want to use the drug in the future for relapsed refractory disease, as well as in the frontline setting. So we'll have more data. Dr. Issa is following this trial up and doing an expansion here, and we'll have BEAT AML, more data from that trial in 2024 as well. So we do have a pretty ambitious set of goals for revumenib, and how do we take this to new settings? Right now, as on the right side, you see relapsed refractory disease.
We have the monotherapy trials ongoing, and we'll have data for NPM1 in 2024. We have AUGMENT-102, which is a chemo combo. Also, we presented data, we're not showing it here, but we presented data at the ASH meeting, and then the SAVE trial, which was likewise presented. I just reprised the data for you. So many regimens, several regimens in relapsed refractory disease, and then also going to the frontline, and we have BEAT AML in phase I and expanding to phase II. And also, we'll be starting trials in the frontline setting, revumenib plus intensive chemotherapy 7+3, moving on to maintenance.
So multiple settings being able to address both NPM1 and KMT2A in the frontline, newly diagnosed patients for what they call the unfit population, where they use ven/aza, and the fit population, where they use chemotherapy, and then also using it in a variety of ways in relapsed refractory. This is how you control the landscape. We will be the first, and we believe, best menin inhibitor on the market. We'll have the drug on the market if it's approved, probably two, at least two years in advance of the rest of the competition. So this is the market as we see it, the market opportunity. We think it approaches $4 billion-$5 billion in total in all the different segments.
As you notice on the lower left there, the relapsed refractory KMT2A and NPM1 population is, it's about 5,000-7,000 patients and represents close to $2 billion market opportunity, and that expands as you add the earlier line indications up to more than $4 billion. So I've talked a lot about revumenib. Let me move on to axatilimab and quickly go through that as well. So this is our CSF-1R antibody with, with we're obviously have done our, our pivotal program in chronic graft-versus-host disease, and we expect the drug to be approved in 2024 with opportunities to expand. We do have a partner, Incyte is our partner here, and we've been working closely with them to advance the program. There are about 14,000 patients who have chronic graft-versus-host disease.
If you don't know, this is a complication that arises out of stem cell transplants. So patients receive stem cell transplant and get this multi-organ fibrotic and inflammatory disease, and it's quite difficult to navigate. So it is a growing market, and that is something that we are obviously looking to to impact. So what are physicians looking for? They're looking for a drug that has obviously a a new mechanism. So we're bringing this chronic, I'm sorry, CSF-1R antibody to affect the macrophage, which we think is a a very important point of differentiation for this drug. It benefits both fibrotic and inflammatory components, and what we've seen in trials today, very consistent results across all subset of patients and all organ systems.
As I said, it's a multi-organ disease, so you have fibrosis across a number of different areas. The trial that we ran is known as AGAVE-201. It was a global trial, 241 patients randomized one-to-one to one, three different doses. The endpoint in this trial was overall response rate by cycle 7 day 1, and the statistical significance was to exceed 30% as a lower bound. We did look at secondary endpoints, such as duration of response, and obviously we hit the endpoint. I don't think we show it all the detail here, but we did hit the endpoint for all three doses in this trial.
So this is, this is the focus on and what we presented at the plenary, the focus on the 0.3 mg/kg dose every two weeks. Responses were quite durable and really were accompanied by a reduction in symptom burden. If you look at this as sort of best-in-class efficacy, 74% overall response rate by cycle 7 day 1, the primary endpoint. 60% of the responders were maintaining their response at one year, and 55% of the patients in the self-reported outcome, on the Lee Symptom Scale, have reported more than seven-point decreases, which is highly significant. So not only did we reach the primary endpoint, but we showed durable responses and a reduction in symptom burden, which was noteworthy. And the drug is extremely well-tolerated with, you know, adverse events consistent with on-target effects of CSF-1R inhibition.
So this, I mentioned the multi-organ disease. This is a breakdown by organ of how patients reported so the complete response and partial response. I'll note a couple things. Number one, in the lung, which we are gonna do an IPF trial. We just started an IPF trial, which is very exciting as a next indication, but I'll note the lung. In this indication, you generally don't see complete responses in lung, and it was very noteworthy to physicians. I'll also note, in terms of skin, the 27% response rate. If you dig in, 44% had a reduction in their BSA involved by sclerosis. Sclerosis of the skin is a serious complication, and 66% had improvement in skin and joint tightening severity, which-...
Indicates that patients are actually benefiting significantly from this drug in very hard-to-treat organs, such as the skin and from the lungs, in the lungs. So it's a big market opportunity, we believe, for chronic graft-versus-host disease. I mentioned the 14,000 patients, about 5,000 of them are treated in the third-line setting. We are also looking to expand the use of this drug into earlier line settings. The way to do that is you combine it with drugs like Jakafi and steroids to move it earlier in the treatment paradigm, and those trials are going to be initiated in the middle of 2024. And as I mentioned, we'll have approval, we believe, in 2024 as well.
We'll be expanding—well, Incyte will be expanding the use of this drug, and developing it outside the U.S., where the patient population grows significantly. And then, as I mentioned, we started an IPF trial. Really interesting new mechanism, offering for these patients, addressing upwards of, you know, 200,000 patients. It's a very different dynamic in those populations in that market, but we think this could be quite impactful in a reasonably short period of time for those patients as well. So that trial is initiated, and we're excited to follow that up. So this is our cash situation. I'll mention... I did mention early on that we did an offering, at the end of last year, following the ASH set of data presentations.
Cash at the end of the third quarter was $379.3 million. We added $258 million net through our offering, as well as some of the proceeds off of our ATM in the fourth quarter. And so on a pro forma basis, as of third quarter, we're about $650 million on the balance sheet. Research and development's expense, $160 million-$165 million for the full year, and total operating expenses, excuse me, $225 million-$230 million, which includes non-cash stock compensation. So some milestones, I won't reprise, excuse me, reprise all the milestones. Let me mention a few.
Again, we will, for revumenib, potentially have an approval in adult and pediatric, relapsed refractory KMT2A acute leukemia in 2024. We say mid-2024. This again, is being submitted under RTOR, and we have, you know, constant interaction with the agency, so it's a really intense period for the company, but an exciting one. We, we will be starting some combination trials, both with intensive chemotherapy for patients who are known as fit in the frontline setting, as well as, following up on, on BEAT AML and, the unfit population in combination with ven/aza. And we'll be expanding, some of the other trials that we're doing, and we're, we're starting a trial, for, ven/aza in the front line for, for a pivotal trial by the end of this year.
For axatilimab, again, we hope to have the drug approved in the middle of 2024. That's again, for third-line chronic graft-versus-host disease, and we'll initiate combinations with our partner, Incyte, for combination for Jakafi as well as for steroids in mid-2024. So a very exciting year for Syndax as we transition to a commercial-stage organization. There aren't a lot of companies that have two products at our size, actually going to be hopefully approved in really the same time. So it's a time of growth, and we're just quite grateful for all the work that's gone into these two programs, and we thank you for your support. So with that, maybe I'll stop for questions.
Yep. Thanks, Michael. Many of you have probably heard me say this at all the other sessions, but there are three ways to ask a question, right? There's the old school way. Just raise your hand, I'll call you, on you. It's like the hip, new way, where you go into your portal and submit a question, and it comes up on this iPad, and I can ask it anonymously. I guess there's an intermediate strategy too. You could just email me, and I'll still ask the question anonymously. So any of those work. But I will, I will kick it off, with a question on... I guess, coming out of ASH, when you think about KMT2A and what you learned at the meeting, what are the, what are the read-throughs as you think about what you learned at ASH KMT2A that's applicable to NPM1?
Yeah. Well, look, I think the, and I mentioned it in my talk, I think the consistency, we had updated the NPM1 data back in the fall, so we know that the overall response rate, about 50%, the CR/CRh rate is about 36%. And as you saw, the pivotal data displayed for KMT2A, our overall response rate in the 60%-65% range, and a CR/CRh rate of 23%. Very similar numbers and consistent with what we see for NPM1 in that data set. I think the other part of this is that we've been able to show patients who are dosed NPM1 and KMT2A in earlier line settings with ven/aza, as well as in the relapsed refractory setting, and we're seeing pretty much identical type responses.
We're seeing patients stay on drug for a long period of time, go to transplant, go back on drug, stay on drug, and be in remission for months, if not years. That applies to KMT2A, and it applies to NPM1. So we see consistency across the board, and we just saw more data to demonstrate that at the, at the ASH meeting.
Questions from the audience?
At ASH, we got a lot of combination updates, and then today in your presentation, you talked about starting some combination studies, this quarter, as well as a ven/aza combo at the end of the year.
Yeah.
Maybe just what is the broader sort of strategy for combinations for revumenib?
So the broader strategy is really focused on ven/aza in the frontline setting for patients who are unfit. So that's about half the patients or so who are not fit for chemotherapy, right? So the standard of care is then combined with aza, and we're looking to make this a triplet. So can we add to that regimen to really impact these patients? That's one pillar of the strategy. Why? Because that's where all the patients or a lot of the patients are, not all of them. We have, you know, a fair amount of patients in relapsed refractory disease, but you want to get these patients as early as possible and treat them for as long as possible, keep them in remission, and that's the place to that you want to focus on time.
But you can't do it without that combination regimen. Likewise, same thing goes for the unfit population, which is where patients who are... Sorry, the fit population, patients who are fit for intensive chemotherapy. You want to combine revumenib with intensive chemotherapy and impact their disease in a similar way, but drive them to hopefully a transplant, get them to, you know, remission, get them to transplant, and then put them back on drug. The, again, earlier you can treat these patients, the better they do, the longer they stay on drug. And that's the paradigm, and you want to be able to access these two important pillars, these two standards of care. There will be other combinations that we do, but they will be probably of lesser importance overall.
Questions from the audience? Yes.
Yeah. With two weeks left to the launches, this year, could you comment on your commercial preparedness?
Yes. The question is, with two launches coming in 2024, can I comment on our preparation or preparedness? I'll say that we've been working at commercial as at, you know, the commercial preparation for quite some time. There are certain things you do within a short period of launch, such as hire some sales reps and things like that. But we've put our entire commercial leadership team in place, and we have a robust strategy to execute over the next handful of months until we're ready, and we will be launch-ready in advance of any approval, under any scenario. So, this is a focus—I would call it a focused footprint for two drugs. So we have the co-promotion option, which we elected to do, for axatilimab with Incyte. We just announced that.
And that affords us about 30% of the FTE effort for axatilimab and the commercialization of that drug. And for revumenib, obviously, we're commercializing in the U.S. Our field force will be sized for revumenib, and we'll accommodate our 30% for axatilimab. It's a very, again, a very focused, overlapping field, field force for to cover both drugs. And so that's a big advantage to have two products at the same time. So our preparation, again, starts with leadership and then ultimately goes to our field force, which we will hire in 2024 in advance of launch. So everything is on track. That's a good question. Thank you.
Additional questions from the audience? Go ahead.
You expect to launch in other countries. And your regulatory team is prepared to support that?
Right. So the question, if I can repeat it for everybody here, is that, are we prepared to launch, get our drug approved and launched outside the United States? I think the... There are a couple pieces to this. So our focus is the U.S. in terms of commercialization. So we've said that at the right time, when the drug is going to get approved ex-U.S., we would look to bring on a partner to support us in the commercialization of the drug outside the United States. In terms of getting the drug approved outside the U.S., we have some work to do with the agencies in Europe, for instance, to get some advice, and we're gonna get that advice about our current trial and whether that suffices for approval ex-U.S.
We'll have that, those conversations with those agencies in the 2024 timeframe. But in terms of getting the drug approved, we may have to, beyond a pivotal trial that, like the one we just did, we may have to do additional work for registration outside the U.S. And so our team is engaging in those discussions in order to advance that.
Just to be clear, that you're talking about revumenib?
I was talking about revumenib. So to be clear, axatilimab is partnered with Incyte outside the U.S.. So development outside the U.S. and registration outside the U.S., that is something that they lead by way of our agreement with them.
Question. Other questions from the audience?
So, you know, because of the size of the KMT2A population, there is this view out there that perhaps this is a niche indication in acute leukemias. Where would you push back on that, or, or what levers do you think the Street is underappreciating with that kind of a statement?
Yeah. No, I think we would push back. I mean, we don't agree with that, and I'll tell you why. KMT2A is, I would call it a rare indication in the sense that there's nothing for these patients, right? It's 2,000 patients that are in desperate need of new therapy. And as we showed you today, we have something that can really impact their disease. The ability to put a new drug into the hands of physicians and allow them to treat these patients as early as possible and keep them on drug for months, if not years.
2,000 patients at premium pricing, and these are drugs that are priced in the, you know, somewhere between $30,000-$40,000 a month because they have a big impact on the disease. Our drug will be priced that way, and we believe even you know, accessing 2,000 patients and keeping them in remission and keeping them on therapy for months, if not years, can be a very meaningful market opportunity. And so we had said that we'd kind of stake that out at about a $750 million market opportunity for KMT2A alone, with no competition. And although the menin inhibitor space is becoming more competitive, we'll be the first, and we think, best in class. But in terms of KMT2A in monotherapy, nobody's even really close in terms of development. They're just several years behind us.
So again, I say it's a rare opportunity. It'll be our first indication, where patients are in dire need of new therapy, and physicians like the profile and have gotten comfortable with using it in a post-maintenance capacity. So all of those things add up to a, I would say, a very robust start for this for this program.
Additional questions from the audience? Oh, yeah.
One question here. Are there other genetic mutations or changes that could be susceptible to this pathway?
Yeah. No, that's a, it's a great question. Are there other genetic subtypes that could be susceptible? So we know of a few. We are looking for others. So, you know, NPM1 is a mutation. KMT2A is, excuse me, is a rearrangement, and then, there's something called NUP98, which is another mutation. And there may be others. We're looking at a gene signature called HOX/MEIS upregulation, that may indicate what else is available to us by way of, as you say, mutations or subsets of patients. We do think that it's probably more than 40%. It's probably approaching 50% after we do some more work to identify these patients. But in leukemia, that's probably where it tops out.
Now, there may be other opportunities for the drug in areas of solid tumor, and we're looking at colorectal cancer, a third-line colorectal cancer, and tracking with this thesis, beta-catenin upregulation, and we're looking at solid tumors to see if menin blocking the interaction between menin and MLL has an impact on that pathway. So that'll be some data that we share this year. That could expand beyond the mutations and rearrangements that we're working on in AML and ALL, but that's, you know, to be determined. But yeah.
Additional questions from the audience?
Can you walk us through, just the RTOR and what that enables you to do with regulators that you might have not been able to do otherwise?
So RTOR, just to remind everybody, RTOR is Real-Time Oncology Review. It's a relatively new program. FDA put this together, I think, back in 2018. It was originally conceived to have real-time review for applications that were sNDA, so supplemental applications, second indications, third indications, if you will. They expanded that to initial indications. And so what it does is it creates this close working relationship with the agency. In order to actually get into the program, you need to have breakthrough therapy designation, and you need to have other designations that already signal that you're pretty close to the agency and you're working very collaboratively with them. So we have breakthrough therapy as well, and we do expect to get priority review as part of this.
But what it does for us is it gives us the ability to submit a series of modules on a schedule with the agency and eliminate this period of time. Usually, when you submit your application, you have a period of time where they can refuse your file. So they can say, you know, "This isn't adequate." It doesn't really exist under RTOR because you're constantly reviewing with the agency what you're submitting, and they can query you at any time. So it's a rather intense period, but what it ultimately does is it speeds up the time to potential approval because you're—they're not waiting to review the whole package. They're, in fact, reviewing it all along. So rather than having, you know... You do have the normal eight-month PDUFA time, but they usually beat it.
They usually come in inside eight months, somewhere in the, you know, six to eight-month period. So it gives you a little bit of, closer interaction, a lot closer interaction than the normal process, and hopefully, it, you know, increases the speed at which, to which you get your approval. So it's quite beneficial.
Any final questions? Okay. Thank you, Michael.
Thank you so much.