Hello, welcome to Celcuity conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question- and- answer session. To ask the question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. I would now like to hand the conference over to Jodi Sievers, Head of Investor Relations and Corporate Communications. You may begin. Thank you, operator. Good day, everyone. Thank you for joining us today to discuss FDA approval of gedatolisib. Today's press release, U.S. prescribing information, and the slides we'll be reviewing today are available on our website, celcuity.com. Before we begin, I must point out that some of our comments today contain forward-looking statements that are subject to risks, uncertainties, and assumptions. In particular, our expectations around gedatolisib are uncertain and subject to change. Should our expectations fail to materialize, or should our assumptions prove to be incorrect, actual company results could differ materially from these forward-looking statements. A description of the risks, uncertainties, and assumptions is included in our SEC filings. With that, I will turn the call over to Brian Sullivan, Co-founder and Chief Executive Officer of Celcuity. Brian? Thank you, Jodi. Joining me on today's call are Dr. Igor Gorbatchevsky, our Chief Medical Officer, who will provide an overview of REVTORPYK's label and the supporting data for patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer. Eldon Mayer, our Chief Commercial Officer, will provide an update on our commercial strategy and preparations for the REVTORPYK launch. Then I'll wrap it up with some upcoming milestones. Let's please turn to slide four. All right, now slide five. Let me start with the reason for the call. Today, we received notification from the FDA that gedatolisib, or now REVTORPYK, was granted full approval in the United States for the treatment of HR-positive, HER2-negative, locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after one or more lines of endocrine therapy in the metastatic setting. REVTORPYK is the first and only multi-target PI3K/AKT/mTOR or PAM pathway inhibitor that has received FDA approval. We believe that REVTORPYK has a best-in-class benefit risk profile for patients and marks a significant step forward towards transforming treatment for patients with locally advanced and metastatic breast cancer. This approval is a transformative milestone for Celcuity as we now transition to a fully integrated commercial stage company. We seek to advance REVTORPYK with additional indications in breast cancer and prostate cancer. Let's turn now to slide six. The PAM pathway is one of the most important targets in cancer, but comprehensively and safely inhibiting it has stymied researchers and drug developers for nearly two decades. REVTORPYK addressed this 20-year challenge by potently targeting all class 1 isoforms of PI3K and mTORC1 and 2 without inducing the unacceptable levels of toxicity that prevented other comprehensive inhibitors from advancing. The primary reason why PAM inhibitors have had limited impact, despite the importance of the PAM pathway, is because it is very difficult to safely and efficaciously inhibit this pathway. It has multiple components, each of which need to be inhibited to comprehensively blockade the PAM pathway's activity. Otherwise, if only a single component is targeted, adaptive resistance arises and pathway shutdown is limited. Our published in vitro studies have found that geta, or REVTORPYK, is 300-fold more potent than the approved single target PAM inhibitors and the only one that is cytotoxic. The two positive phase III readouts from VIKTORIA-1 in the second-line setting established a strong foundation for us as we prepare for launch. In breast cancer alone, when we include the potential opportunity in the first-line setting, the total potential patient population we could treat over the long term is over 130,000 patients, and the total addressable market potential is over $10 billion. I'd like to now turn the call over to Igor Gorbatchevsky, who will review the U.S. prescribing information and key clinical data supporting the approval. Let's please turn now to slide seven. Thank you, Brian. Hello, everyone. At Celcuity, we're very proud and grateful for this opportunity to deliver REVTORPYK to our patients. Our heartfelt thanks go out to all patients and their families and caregivers, investigators and their teams, FDA reviewers, and the dedicated Celcuity team whose efforts made REVTORPYK approval possible. Let's turn to slide eight. I will overview REVTORPYK prescribing information. REVTORPYK is approved in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone-positive and HER2-negative locally advanced or metastatic breast cancer without PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in metastatic setting. The recommended dosage of REVTORPYK is 180 mg as an intravenous infusion over 30-minute period, once weekly on days one, eight, and 15 of every 28-day cycle, in combination with fulvestrant, with or without palbociclib. Treatment continues until disease progression or unacceptable toxicity. There is no contraindications, and the warning and precautions include some of the class' stated side effects. Let's turn to slide number nine. I will now summarize some key data from the REVTORPYK label related to efficacy of this treatment. The approval of REVTORPYK is based on positive clinical results from PIK3CA wild-type cohort of the Phase III VIKTORIA-1 trial, which is an open-label, global, randomized clinical trial evaluating the efficacy and safety of REVTORPYK plus fulvestrant, with or without palbociclib, for treatment of patients with locally advanced or metastatic hormone-positive, HER2-negative breast cancer following progression on or after CDK4/6 therapy and an aromatase inhibitor. In total, in this study, 392 patients were randomized equally, 1:1:1, in three study arms. Two of the study arms were experimental, including REVTORPYK plus fulvestrant and palbociclib, or REVTORPYK in combination with fulvestrant, and the control arm included fulvestrant monotherapy. In the VIKTORIA-1 trial, the median progression-free survival with REVTORPYK triplet, it is REVTORPYK plus palbociclib and fulvestrant, was 9.3 months versus two months for fulvestrant. An incremental improvement of 7.3 months, a hazard ratio of 0.2x, a 95% confidence interval 0.17 to 0.35, and P value below 0.0001, representing a reduction in the risk of disease progression or death by 76%, or quadrupling median progression-free survival compared to standard of care. The objective response rate of the REVTORPYK triplet regimen was 32% compared to 1% with fulvestrant, and the median duration of response was 17.5 months. To slide 10, please. Now we will review results for REVTORPYK doublet regimens. For REVTORPYK doublet or REVTORPYK in combination with fulvestrant, the median progression-free survival was 7.4 months versus two months for fulvestrant. An incremental improvement of 5.4 months or hazard ratio of 0.33x and 95% confidence interval 0.24 to 0.48 and P value below 0.0001, representing a reduction in the risk of progression or death by 67% versus fulvestrant, or tripling median progression-free survival compared to standard of care. The objective response rate for REVTORPYK doublet was 28%, and the median duration response was 12 months. The median duration of response for fulvestrant was not determinable because there was only one response. Now let's turn to slide 11. Next slide. The safety data from the PIK3CA wild-type cohort of phase III VIKTORIA-1 trial showed that REVTORPYK was generally well-tolerated, with most adverse reactions being of grade 1 and 2. No dose reductions or treatment discontinuation of REVTORPYK occurred due to hyperglycemia. Stomatitis was generally manageable, occurred early, and incidence of this reduced, including with severity, with each treatment cycle. Serious adverse reactions occurring in more than 1% of patients, including pneumonia, thrombosis, stomatitis. Now I will turn over to Eldon Mayer, who will review the commercial strategy and launch plans for REVTORPYK. Thank you, Igor. I'd like to review some highlights of our launch plans for REVTORPYK, and as I do, you'll see why we believe REVTORPYK is positioned for strong market adoption. Turn to slide 13, please. We believe REVTORPYK is well-positioned for strong market adoption in both PIK3CA wild type and, if approved, for mutant advanced breast cancer. To first address the market opportunity, within the U.S., approximately 37,000 patients with HR-positive, HER2-negative advanced breast cancer receive second-line treatment each year following progression on CDK4/6 inhibitors. Of these, roughly 60% are PIK3CA wild type and 40% are PIK3CA mutant, and importantly, FDA approval of both indications would allow REVTORPYK to address 100% of this market with the simplicity of a single PIK3CA-agnostic treatment approach. This would be a major differentiator versus currently available therapies that are restricted to either mutant or wild type patients. There remains a significant unmet need in this market for therapies that deliver better efficacy without compromising safety. REVTORPYK's unique mechanism of action as a potent pan PI3K mTOR inhibitor, combined with its pharmacokinetic profile and IV route of administration, provides a distinct efficacy-safety profile relative to existing oral agents. Taken together, we believe REVTORPYK will offer a compelling value proposition, best-in-class efficacy with a tolerable safety profile that positions it to become the new standard of care in this setting. We estimate a $6+ billion total served market opportunity across both wild type and mutant populations, excluding potential first-line usage. Turn to slide 14, please. Recent quantitative market research among breast cancer-treating physicians has validated a clear medical need for new treatments in second-line PIK3CA wild type advanced breast cancer. The chart here shows how physicians allocated their use of current treatment options. The sizes of the arcs are scaled to depict the relevant market share of each treatment choice. What's clear is that this market is fragmented. There's no go-to treatment option in this setting, with each treatment option holding a minority market share among the various patient types. This sets the stage for a new treatment with strong benefit/risk ratio to potentially establish itself as a new standard of care. Turn to slide 15, please. We are entering this launch with significant market and organizational momentum. First, we have built important relationships with key stakeholders in this market. We've engaged over 1,500 key opinion leaders and community breast cancer experts, over 200 key accounts, major oncology organizations, including GPOs, state societies, and special interest groups, as well as patient advocacy groups. Our unbranded marketing campaign at panpathway.com has already driven awareness of the PAM pathway, with metrics tracking well ahead of industry benchmarks. CME and third-party peer-to-peer programs and regional events have increased levels of education with the unmet need in HR-positive, HER2-negative advanced breast cancer. Importantly, we have a robust launch plan in place that includes a comprehensive array of tactics and programs, including promotional materials, digital media campaign, speaker bureau, and peer-to-peer promotional programs, as well as an increased presence at national and regional oncology conferences. Importantly, we have a deeply experienced and trained teams that are already deployed and ready to deliver, including our sales force of 100 people including sales management, teams for strategic accounts, payer and reimbursement, KOL-focused teams, and importantly, our medical science liaison team. This experienced customer-facing organization gives us immediate execution capability from day one of launch. Turn to slide 16, please. Patient access to drug is a critical priority and therefore, we have designed comprehensive support solutions to offer patients and providers rapid and seamless access to REVTORPYK. Prior to FDA approval, our market access field teams achieved 100% engagement with the top 36 strategic accounts and 100% engagement with top payer and provider pathways covering over 90% of U.S. medical benefit lives. We designed a tailored distribution model that is optimized for patient access to REVTORPYK. Our comprehensive patient support programs include digital patient enrollment, benefits investigation, prior authorization and appeal support, co-pay assistance, and a patient assistance program. In summary, these foundational healthcare provider and patient systems and programs are expected to support rapid uptake upon launch. Turn to slide 17, please. Our launch priorities are clear. Drive awareness, achieve rapid adoption, and deliver patient access to REVTORPYK. Our sales force will cover approximately 9,000 healthcare providers that treat HR-positive, HER2-negative advanced breast cancer with a focus on the 2,000 providers that treat a high volume of breast cancer patients. Their priorities will be to differentiate REVTORPYK by highlighting its unique mechanism of action, strong efficacy, and a tolerable adverse event profile, as well as supporting patient access to drug with expected payer coverage and patient services. Our high-performing team of 88 oncology sales specialists has an average of 24 years of industry experience and a track record of 362 President's Club Awards, which means that they were in the top 10% of sales performers in their prior companies during the relevant years. Turn to slide 18, please. This approval truly marks the beginning of an exciting new chapter for patients with advanced breast cancer, for healthcare providers, and for Celcuity, as well as laying a foundation for multiple potential indications in first and second line advanced breast cancer. Considering the U.S. market alone, we believe that second line, first line endocrine treatment sensitive, and first line endocrine treatment resistant markets represent addressable patient populations of approximately 37,000, 59,000, and 33,000 respectively, which when combined, represent a potential U.S. market opportunity that exceeds $10 billion. Slide 14, and with that, I'll turn it back to Brian. Thank you, Eldon. We've made a lot of progress over the past year, and if we're not on slide 20, let's please turn to slide 20. Over this past year, we're looking forward to continued data generation, regulatory filings, and news flow over the next six to nine months, including several of these key milestones. Today, of course, we're announcing the approval of REVTORPYK. Next, in the third quarter, we'll be submitting a supplemental NDA to the U.S. FDA seeking approval for the treatment of HR-positive, HER2-negative patients that have PIK3CA mutations in the advanced breast cancer setting. Second and thirdly, we'll be submitting VIKTORIA-1 PIK3CA wildtype cohort data to NCCN this quarter. Later in the quarter, we anticipate commercially launching REVTORPYK. Based on the company's commitment to ensuring broad, affordable, and unrestricted patient access to REVTORPYK, we've designed a comprehensive patient support program to make REVTORPYK available to patients prior to commercial launch program. To make REVTORPYK available to patients prior to commercial launch, those who are eligible will be able to enroll in Celcuity's expanded access program. Additionally, Celcuity is qualified as second drug manufacturer and will be submitting a post-approval supplement to the recently approved NDA for FDA review. Throughout the rest of the year, we'll present additional data from our clinical programs, including an update to our phase I-B metastatic castration-resistant prostate cancer study in fourth quarter. We'll also be providing an update on VIKTORIA-1 PIK3CA wild-type and mutant cohort data in the fourth quarter as well. We currently anticipate submitting an MAA for both wild-type and mutant data to the European Medicines Agency and similar filings with other regulatory authorities outside the U.S. following submission of the sNDA to the FDA. Let's now turn to slide 21. I think now is the time for questions. Thank you. Ladies and gentlemen, as a reminder to ask the question, please press star one on your telephone, then wait for your name to be announced. To withdraw your question, please press star one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Maury Raycroft with Jefferies. Your line is open. Hi. Much congrats on the approval and thank you for taking my questions. Maybe starting, I'm wondering if you can comment on pricing and what that looks like relative to other agents starting PI3K. I've got one other follow-up question. Sure. We'll be announcing or rather releasing a pricing to the various compendia that compile pricing from drug companies. Those compendia are used by various constituents who will be either reimbursing or purchasing the drug to determine the pricing that they may ultimately access. Until that process is completed, we won't be announcing a specific price. That will be announced soon after those compendia are available to our constituents. Got it. I can say that the price will be a premium relative to what currently available therapies are. Okay. Understood. Just comparing the safety profile in the label to what was previously reported in the wild-type study, there are some modest differences in some of the AE rates. Can you just help understand what's driving these variances in the function of long follow-up patient population reporting methodology? Sure. I'll answer that directly. We reported treatment-related adverse events, those are events that the investigator, person treating the patient, identified as related to specific therapy, whether it was gedatolisib or some other therapy. The FDA reports all adverse events, they're labeled treatment emergent, whether or not they're related at all to or believed by the investigator to be related to the therapies that were prescribed. The difference then would be in any of those numbers would be events that in the investigator's determination were not related to therapy. The FDA takes a view that they will report and want to report on the label every event that was reported, whether or not it was related to the therapy itself. Got it. That makes sense. Thanks for clarifying. Thanks for taking my questions. You're welcome. Thank you. Please stand by for our next question. Our next question comes from the line of Tara Bancroft with TD Cowen. Your line is open. Hello, this is Sam on for Tara Bancroft. Thanks for taking our question. Congratulations to the entire team for reaching this milestone. I just wanted to ask about the launch over the next year. How do you expect the initial sales ramp will evolve? Are there any key time points or gating items that we should be aware of after the launch in late Q3 that could lead to an inflection in uptake? For example, like a J-code activation or just the cadence of formulary reviews for practices. Sure. No. Thank you for the question. I'll give a little preview, then Eldon can fill in the blanks. Obviously, at launch, there's more friction than there'll be over time. You mentioned J-code. At the outset, the company will launch with a temporary J-code. There are very specific time points when J-codes are assigned. Accounts are very used to working with new drugs, our market access team will be coordinating, as well as our oncology sales specialists, working with accounts to help facilitate that process for getting the drug reimbursed. One of the primary concerns that accounts have is the delay in getting reimbursed, because this is a buy-and-bill drug. We've put in place a program that we'll be offering accounts extended dating, so that they won't in effect be cash flow negative when they prescribe this therapy. That, in the experience of our team, really significantly addresses the potential barrier that a temporary J-code can create for the accounts. Eldon, I don't know if you have any color to add to that. No, Brian, I don't think I have anything significant to add to that. Great. Thank you. You're welcome. Please stand by for our next question. Our next question comes from the line of Brad Canino, with Guggenheim. Your line is open. I will add my congratulations as well. I want to ask about the treatment duration. This has come up in conversation with investors quite a bit. I know in the JCO, and even this label, they reflect a median duration of exposure of about six months. When you do your TAM estimates, you're using 10 months treatment assumption. Can you help us understand this median metric? Is that the right thing to think about in terms of an average treatment duration you would expect when you get into these real-world patients? Thank you. No, that's a good question. The treatment duration is hampered by or not hampered, but is significantly affected by the relatively short follow-up period. You essentially understate what is the actual experience that we expect patients to be on. We estimate that patients based on their persistence on the therapy, which is really the best way to look at that or calculate that, is looking at the average duration of patients, since that is obviously the number that would get plugged in any formula estimating drug usage. The 10 months that we allude to on the presentation reflects essentially nine. That's the average between nine and 11 that we reported for the triplet with the PIK3CA wild-type and mutant therapies. Our persistence analysis with the data that we have suggests that PFS is a very good representation of the likely drug duration that patients on average will experience when they're on treatment with data. Thank you. Thank you. Please stand by for our next question. Our next question comes from the line of Silvan Türkcan with Citizens. Your line is open. Thank you so much for taking my question and congrats on this major milestone here. I just have a quick question on, you mentioned that the struggle you did buy and bill. Is there any portion that will be through specialty pharma and bill directly to patients, or is it 100% buy and bill? Thank you. Eldon, why don't you answer that question? I know it's a buy and bill. None of the drug will be prescribed to patients directly. Obviously, it's an infused therapy that requires administration in a facility. There might be some take-up by specialty pharma. Eldon, could you maybe address that question? Yes. That's correct. We have contracted with a specialty pharmacy that will be able to distribute and handle benefits administration and other services they offer for specific doctor's offices, practices that are typically smaller and do not want to take on the burden of purchasing the drug and waiting for reimbursement. At times they will do what's called white bagging, where they will have the drug shipped to the patient and the patient will bring it in. We expect this is normal. We expect this to be a very small portion of our business, probably low to mid-single digits at most on a percentage basis. We're prepared for this, and we will offer this, but we don't expect it to be a significant portion of our business. Great. Thank you so much for the insight. Congrats. Thank you. Our next question comes from the line of Eva Fortea with Wells Fargo. Your line is open. Hi team, thanks for taking our question, congrats on the progress. A quick one from us. You guided towards the late third quarter launch. We're just wondering, what are the gatekeeping steps before commercialization can begin? Thanks. The primary gate is just making sure we have sufficient drug available at time of launch. You have a wide confidence interval in your estimate of drug requirements. We want to make sure we have sufficient drug available at that time. We're being somewhat conservative in our estimates of when that drug will be available. Got it. Thanks. Thank you. Please stand by for our next question. Our next question comes from the line of Oliver McCammon with LifeSci Capital. Your line is open. Hi. Congratulations on the approval decision, thanks for taking my question. I'm just curious on when and whether you'd expect overall survival data, when mature, to potentially be added to the FDA label. I'm also wondering to what degree survival data could play into gedatolisib on the NCCN guidelines and what the timing could potentially look like there. Thanks again. Thanks, Oliver. The OS data, at the time of initial reporting, alpha data was not mature, still not mature. It's an event-driven analysis, we expect to reach that threshold probably first half. Again, it's somewhat hard to predict. Sometime in first half 2027. As far as NCCN guidelines, obviously in the second-line setting, no drugs have shown an overall survival statistically significant benefit. That has been taken into account, I think, as they review the drugs and the data. Certainly, in the first line setting, there have been drugs that have achieved an overall survival significance milestone or endpoint. Those reviews of the data might place different weight on the OS analysis from the PFS analysis. Thanks for your time. Thank you. Please stand by for our next question. Our next question comes from the line of Gil Blum with Needham. Your line is open. Thank you. Hi, guys. This is Jonathan on for Gil. Congrats on all the progress as well as the approval. I just had a quick question on what percentage do you expect for patients that will be on the doublet versus the triplet? Thanks. We have two data points that help inform our answer. The first is the percentage of doctors that selected the triplet versus the doublet when they crossed patients over from the fulvestrant arm to one of the study treatment arms in the VIKTORIA-1 study. In that case, roughly 85% of the patients were assigned to the triplet arm, the balance to the doublet arm, of those that crossed over. As it turns out, the market research we've done, essentially quantitative research with treating physicians, oncologists, were asked that specific question, and it fell into roughly the same proportion, 85%, 15%. Again, we'll see in actual practice, but at least early indications are that very significant majority will start with the triplet instead of the doublet. Great. Thanks again, and congrats again. Thank you. Thank you. Our next question comes from the line of Swayampakula with H.C. Wainwright. Your line is open. Thank you. This is R.K. from H.C. Wainwright. Congratulations, Brian and team. This is a question thinking about community oncologists who would also be an important piece of the commercial structure for you folks. With no FDA-approved PIK3CA companion diagnostic available, how do you see a community oncologist identifying the wild-type patients at launch? Does that cause any slowing in terms of prescribing? Bill, thank you for the question. We don't think it will slow. As it turns out, standard of care today is to test all second-line patients. That's in the NCCN guidance, and that's become a very expected assessment to be performed after patients progress on their first-line therapy. Those results will be applicable to, or rather, usable for determination of a patient's wild-type status for treatment with gedatolisib. We don't view that as a barrier because, again, PIK3CA status is determined as standard of care practice. Thanks. Thank you. Our next question comes from the line of Chase Knickerbocker with Craig-Hallum. Your line is open. Good afternoon. I'll share my congrats as well. Maybe just, Brian, quickly on as we think about launch comps here A lot of the community indication comps we think about may be orally delivered. How do you think about any difference in the early slope of the launch curve as far as an infused therapy versus oral? Is there anything that you guys think about? I think it's hard to point to anything very specific that would affect the ramp. Certainly, there's a little bit more onboarding that's required. All these sites, every site and physician that we'll be working with prescribes infused therapies for breast cancer patients. Some of the largest therapies used, or the most significant therapies used in breast cancer are infused therapies. There is some work, in some cases, it relates to order sets where providing details on how the drug should be handled, et cetera. That would be probably the main difference between an orally administered therapy versus an infused. Just a little bit more set up for the accounts. Beyond that, we don't think there's any barriers just because these community docs, as well as obviously academics, are well-versed in treating patients with infused therapies. Got it. Congrats again. You're welcome. Please stand by for our next question. Our next question comes from the line of Stephen Willey with Stifel. Your line is open. Yeah. Thanks for taking the questions. Congratulations on the approval. I know that there was mention of bringing a second manufacturer online. Can you just speak to the timing? I think I missed the timing specifically. To what extent is that really just good housekeeping from a redundancy perspective? Or is that necessary- No to meet your capacity objectives? No, thank you. Well, two things. It's for capacity and good housekeeping. We simultaneously, once we submitted the NDA, or rather prior to submitting the NDA, we had been working to essentially transfer the process to another manufacturer. You follow a separate process to get their data reviewed, and we'll be submitting a regulatory specific package to the FDA to get them approved to manufacture gedatolisib. They've manufactured the product, and the data's available, and all the material is ready to go. That'll be something that we initiate this week. Again, just good housekeeping and, certainly, we want to be mindful of capacity as well. Understood. Thanks for taking the question. Thank you. Our next question comes from the line of Andrew Berens with Leerink Partners. Your line is open. Hi, this is Emily for Andy. I was wondering if you could provide more color on the process that patients need to go through to actually receive the stomatitis mouthwash and how that will be made available to patients. Thank you. Sure. The patients at the time they come to the treatment facility will be given dexamethasone mouth rinse, and they'll use that prior to getting the therapy. Then they'll leave the hospital or the infusion center with the dexamethasone that'll be prescribed and provided at the time that they visit that infusion center. The nurse will obviously educate the patient about best practice and oral care in general. Again, because dexamethasone is widely used for cancer patients, many other therapies induce stomatitis. It's something that the treating physicians as well as the nurses are very familiar with and able to effectively train the patient, just educate them about that. It's very straightforward from an education and onboarding standpoint at the site. Then for the patient, it's very simple. It's just, they call it swish and spit, it simply requires them to essentially use the equivalent of a mouthwash daily. Thank you. Ladies and gentlemen, I'm showing no further questions in the queue. I would now like to turn the call back over to Brian Sullivan for closing remarks. Great. Thank you very much, everyone, for attending the call. We appreciate that. I'd like to close just by thanking, as Igor did, the numerous patients and their families who participated in our trial and who are also participating in our other trials. We'd also like to thank the clinical investigators and the nurses, site coordinators, and the support staff that's involved in fielding a study like this. Finally, the team at Celcuity did a fantastic job in working to now have this medicine available to patients. We feel privileged to be able to provide this medicine to these patients, and we're looking forward to a fantastic launch. We'll, of course, keep you updated. Thank you. Ladies and gentlemen, that concludes today's conference call.