Greetings, and welcome to the Rigel Pharmaceuticals conference call to discuss FORWARD study results. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the call over to Dolly Vance, Executive Vice President, Corporate Affairs and General Counsel. Thank you. You may begin. Welcome, and thank you for joining us today to discuss top-line results from the FORWARD pivotal Phase III clinical trial of fostamatinib in patients with warm autoimmune hemolytic anemia who have failed at least one prior treatment. As a reminder, during today's call, we may make forward-looking statements regarding our financial outlook and our plans and timing for regulatory and product development. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent annual report on Form 10-K for the year ended December 31, 2021, and subsequent filings with the SEC, including our Q1 quarterly report on Form 10-Q on file with the SEC. Any forward-looking statements are made only as of today's date, and we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances. At this time, I would like to turn the call over to our President and Chief Executive Officer, Raul Rodriguez. Thank you, Dolly, and thank you everyone for joining us today. In addition, with us on the call today are Dr. Wolfgang Dummer, our Chief Medical Officer, David Santos, our Chief Commercial Officer, and Dean Schorno, our Chief Financial Officer. During the call today, I will make some opening comments. Wolfgang will then review data, and then I will make some review our next steps. After that, we will open the call to your questions. Beginning on slide five. In our press release earlier today, we announced the top-line result from FORWARD, our pivotal phase III clinical trial evaluating fostamatinib in patients with warm autoimmune hemolytic anemia, or warm AIHA, who have failed at least one prior treatment. The FORWARD trial was based on the positive results from our phase II study, which was conducted solely in the U.S. and showed a compelling response in its patient population. We were surprised, therefore, that the trial did not demonstrate statistical significance in the primary endpoint of durable hemoglobin response in the overall patient population. However, we saw encouraging results in a post-hoc regional analysis of U.S., Canadian, Australian, and Western European trial sites, showing that patients treated with fostamatinib demonstrated a favorable durable hemoglobin response compared to placebo. This group includes nearly 60% of patients enrolled in the trial. In the Eastern European trial sites, patients did not demonstrate a favorable hemoglobin response, representing a contradictory and confounding result. Importantly, fostamatinib safety profile in the FORWARD trial was consistent with the existing safety database, and no new safety issues were observed. At this time, we are continuing to analyze the data to understand the geographic differences in patient disease characteristics and outcome and plan to discuss these findings with the U.S. FDA. With that, I will now turn the call over to Wolfgang to provide an overview of the FORWARD trial and to review the data. Wolfgang. Thank you, Raul. Moving to slide six. As you are aware, FORWARD was a global, multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of fostamatinib compared to placebo in patients with warm AIHA. 90 patients were randomized one -one to receive fostamatinib or placebo twice daily for 24 weeks. Randomization was stratified by severity of anemia at screening and concomitant steroid use at baseline. The primary endpoint of the trial was durable hemoglobin response, defined as achieving a hemoglobin level of greater or equal than 10 g/dl with an increase from baseline of greater than or equal to 2 g/dl on three consecutive available visits during the 24-week treatment period. The trial also evaluated several key secondary endpoints with additional hemoglobin assessments in the patient-reported outcome, the FACIT-Fatigue score. After 24 weeks, patients had the option to enter into an open-label extension study. Slide seven provides patient disposition for the trial. As you can see, more patients on fostamatinib, 84.4%, completed 24 weeks versus 75.6% in the placebo group. Hence, fewer patients discontinued from the fostamatinib arm for the reasons listed on the slide. 71 patients rolled over into the extension study. Slide eight. Here are the baseline characteristics of the patients who enrolled in the trial. As you can see, as a post-hoc evaluation, we have broken this up by geographic regions because we've seen different efficacy outcomes in those regions. The left two columns show you the overall ITP population, the middle two columns, all Western countries combined, excluding Eastern European countries, and the two columns on the right show you Eastern Europe only. As you can see, demographics and baseline characteristics in the overall patient population were generally well-balanced between placebo and fostamatinib-treated arms. Comparing the Eastern European patients with the Western countries, there are a few major differences which I will elaborate on. The one that stands out on this slide is a substantially shorter duration of AIHA in the Eastern European population compared to Western countries, with a median of about six months in the Eastern European placebo arm versus approximately three years in the Western countries. That could be a reflection of earlier, potentially easier to treat and less treatment-experienced AIHA patients. The dose of concomitant steroids appears also somewhat higher in Eastern Europe than the Western countries. On slide nine, we are looking at prior medications used. The types of prior unique AIHA medications were generally balanced in the overall patient population, as well as across geographic regions. Nearly all patients in the trial had previously been treated with corticosteroids. What stands out here is the much lower exposure to Rituxan, rituximab, about 25% in the Eastern European countries compared to 75% for patients in Western countries. Another indicator for a less treatment-experienced patient population. On slide 10, we can see that a higher percentage of patients, 35% in Eastern Europe, had only one line of prior therapy, and it was steroids, versus 15% in Western countries, and the higher percentage in Western countries have had three or more therapies compared to about 25% in Europe. Slide 11. On the left two columns, you can see the results for the primary endpoint in the pre-specified overall ITP population. 16 patients, 35.6% in the fostamatinib treatment group, achieved durable hemoglobin response compared with 12 patients, 26.7% in the placebo arm with a P value of 0.398. When we looked at various subgroups and by geographic region, we found that results in North America, Australia were similar to Western Europe, but the placebo response rate were much higher in Eastern Europe. If we exclude post-hoc the Eastern European countries from the analysis population, we see durable response in nine patients, 36% treated with fostamatinib, compared to three patients, 10.7% for the placebo group. This would have yielded a P-value of 0.03 with a denominator of 53 patients. In Eastern Europe, on the contrary, we see 35% response rate for fostamatinib versus 52.9%, nine out of 17 responders in the placebo arm. We are carefully analyzing and will continue to analyze this high placebo response rate in Eastern Europe, as it turned out to be very different from the other geographic regions. Slide 12, secondary endpoints. The results for the secondary endpoints are generally consistent with the results for the primary endpoint, with insignificant findings for the overall population, but consistent positive trends for the Western countries, contrasting better placebo results for the Eastern European countries. Approximately 52% of fostamatinib patients in the Western countries achieved the hemoglobin response at least once, compared to 17.9% of patients on placebo. Descriptive nominal P-value is 0.0088. 56% of patients on fostamatinib versus 17.9% of patients in the placebo arm in Western countries achieved a change in hemoglobin of greater or equal than 2 g/dl from baseline. The nominal descriptive P-value here is 0.0038. Change in mean hemoglobin from baseline to end of treatment and also patients free of rescue medication trend favorably towards fostamatinib in the Western countries, but not in the Eastern countries. Finally, FACIT fatigue score showed a seven-point improvement for fostamatinib-treated patients compared with 0.7 for placebo-treated patients in Western Europe. Moving on to slide 13, the safety results show that fostamatinib was generally well-tolerated. There was no substantial difference in overall AE rate, serious AE rate, or deaths between treatment groups. The most frequent AEs observed are generally consistent with what we had observed in previous trials or with the underlying disease. Slide 14. In summary, the study did not meet its primary endpoint to demonstrate a statistically significant difference in durable hemoglobin response for fostamatinib compared to placebo. Overall, we believe the results were negatively impacted by a large placebo response rate from patients treated in Eastern European trial sites. The Eastern European patients seemed to differ in some baseline characteristics from the Western country patients with a shorter history of AIHA, fewer previous treatments, and less previous rituximab use. We will continue to evaluate carefully the impact of any possible imbalance or difference on the trial results. We believe the totality of the efficacy and safety data from Western Europe suggests benefits for fostamatinib patients over a broad number of clinically important outcomes. With that, I'd like to turn the call back over to Raul for closing remarks. Raul? Thank you, Wolfgang. I would like to remind you that warm autoimmune hemolytic anemia is a serious and sometimes deadly disease, and there remains a significant unmet need amongst patients. Currently, there are no therapies on the market specifically approved for this indication. We are encouraged by the durable hemoglobin response observed in patients treated in the Western countries and the positive trends observed in the secondary endpoints in those, which we believe are meaningful. We will continue to analyze the data to better understand the reasons for these geographic differences. Following our internal review of the data, we plan to share the results with the FDA to determine the best path forward for fostamatinib in warm autoimmune hemolytic anemia. We believe fostamatinib may benefit warm autoimmune hemolytic anemia patients, and they need and deserve a new treatment, and we're going to work hard to get them this treatment. On slide 16, before we turn the call over to your Q&A, I'd like to just take a moment to thank all the patients, their caregivers, the investigators, and other healthcare providers for their participation in this FORWARD trial, as well as our employees at Rigel who worked diligently and tirelessly on this program. With that, I'd like to have the operator open the call to your questions. Operator? Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for your questions. Our first question has come from the line of Kristen Kluska with Cantor Fitzgerald. Please proceed with your questions. Hey, good morning, everybody. Thanks so much for taking my questions. The first one that I had was I know that this endpoint allowed for flexibility if patients missed visits. Just thinking about the COVID waves here across different regions, did you notice any trends as it relates to the number of follow-up visits that patients were able to make and if there were any gaps in between these visits when calculating the durability? Thank you, Kristen. I'll ask, Wolfgang to comment. Yeah. Thanks for your question, Kristen. We looked at, you know, the number and frequency of missing data and, you know, fairly surprisingly, the patients, you know, did make it to the site in general, and the number of missing visits was not an explanation for the high placebo response rates in Eastern Europe. We did look, and it's not explaining the results. Okay, thanks. How are you starting to think about the different outcomes that might come out of your meeting with the FDA? You know, it sounds like even if you can't move forward with this, would you consider running another trial? I mean, you know, clearly it sounds like you've seen the efficacy. It's really just this placebo response in Eastern Europe that tended to skew the data here. Yeah. Kristen, thank you. I'll take a stab at that, and Wolfgang, if you could comment as well. You know, it's a bit early as yet. We've just unlocked the database shortly for us to say what we would do. I think importantly, we need to understand this anomaly, and it's a very odd result, as you can assume. I think we need to understand what caused it, was there any other issues that we need to understand, and then provide that with a good review of the data to the FDA. Make sure they understand what happened, make sure they understand that there's a medical need here as a next step, and then we'll wait to see what their feedback is. Wolfgang? Yeah. I mean, you mostly said it. The most important thing for us is to understand the Eastern Europe placebo response. It's over 50%, so there is something really odd in there. While in the Western countries, the result is pretty, you know, consistent actually with what we would have expected. We are, you know, evaluating all kinds of simple reasons why they could have been, and then we have to understand the patient population. I told you know, the Eastern European patient population is a little bit different. These are earlier patients, fewer previous treatments, shorter duration of disease and, you know, on steroids, the effect of fostamatinib might have been masked in the subpopulation. That's... These are all possibilities which we will have to do a lot more analysis over the next few weeks. Once we have a good understanding, we will take it to FDA as well as it and show them the data. It's not the very first time that there are regional differences in clinical trials, and we will discuss it with the agency. To Wolfgang's comment. In the Western countries, the results are very much where we expected them to be, both on the primary as well as the secondary endpoints. The patient population looks very much what we expected it to look like. That gives us the confidence that this product, we believe, does have a benefit. We were able to show it in one of the most important countries in terms of our own commercial efforts as well as in a place that we think is quite relevant. Thanks, appreciate it. Thank you, Kristen. Thank you. Our next question comes from the line of Yigal Nochomovitz with Citi. Please proceed with your questions. Hi, this is Carly on for Yigal. Thank you very much for taking our questions. We're wondering if you could maybe just elaborate a bit on any hypotheses you have for why the placebo response in Eastern Europe patients was much higher than expected. You laid out some of the differences in the baseline characteristics of the prior medications between the different geographies, but I was just curious how you think those may have contributed to the high placebo response rate, or if there were any differences in the protocol itself between the different geographies that could have had an impact. Thank you. Wolfgang, would you take a stab at that? Yeah. First of all, the protocol is valid in binding for all sites and geographic regions. It's not about the protocol. Everybody followed the same protocol. Regarding inclusion criteria, you know, we did require at least one failed treatment or one unsatisfactorily tried treatment, and that could be just steroids. As it turns out, as I said earlier, in Eastern European countries, more patients really only had one prior treatment, which was steroids, and had a much shorter duration of warm AIHA. While in the Western countries, as you could see in the, you know, previous treatment slide, you know, the majority of patients had one, two or even three or more previous treatments, so they were pretty refractory. It is entirely possible that those early patients in Eastern Europe just respond better to steroids alone and continue to respond while they enter the study. As I said earlier, we have to do some analysis to confirm that hypothesis. We did, of course, do a lot of investigation into some, you know, possibilities of what might have gone wrong. I mean, some of you might ask, well, did the patient take the right drug? We confirmed that. Was it about the lab? No, it was not about the lab. Central labs were mostly providing the data. We looked at the PK in the patient to see that patients on fostamatinib indeed got fostamatinib. We did some high-level investigation into you know major mistakes that might have happened. It doesn't look like that's the case. Probably we have to look further into the patient population and see why there might be a higher placebo response rate in the patient population. That's what I can tell you at this point. Okay, got it. That's really helpful. Do you just have an estimate on when you may be able to provide another update after doing sort of a more thorough analysis of the geographic differences? Wolfgang? Yeah, I would say, you know, you know, we had pre-specified for top line, as you know how this works. You pre-specify the programmed analysis for general baseline population. Then you have to formulate some hypotheses, and then you have to do analysis of additional subgroups and excluding some patients and looking at other patients. That takes certainly a few weeks. You know, with the task force working on this. Then we should have a better idea whether we can provide an explanation, which we would take to the agency and see what the response is by the agency. Okay, thank you very much. Thank you, Carly. Thank you. Our next question comes from the line of Yun Zhong with Jefferies. Please proceed with your questions. Hi, this is Nolan on for Yun. Thank you for taking our questions. For the first question, could you please talk a little bit about your cash usage going forward and how you're planning to cut OpEx to extend the cash runway? Thank you. Thank you. Let me ask Dean to comment on that. Sure. Hi, Nolan. Just to remind you at what we said on our Q1 call. We had $107 million of cash. We also highlighted on that call that we expected in Q2 $5 million from our collaboration partner in Japan, Kissei, upon their NDA filing. We've in fact, since that, since our Q1 cash balance of $107 million, we did add that $5 million. We incrementally highlighted that upon if we do get acceptance of that NDA filing, we'd have $20 million of incremental cash in Q1 of 2023. From Kissei. From Kissei. We described that. As far as our runway going forward, we haven't given guidance on our top line, and we haven't given guidance, you know, on TAVALISSE sales as well as collaboration revenues, and therefore, we haven't given specific guidance on the runway. I would say that these results today on autoimmune hemolytic anemia, we didn't have top-line contributions from autoimmune hemolytic anemia until the back half of 2023 anyway. On an immediate basis, this doesn't fundamentally change our cash position, our cash needs in the near term. With that, and given today's market conditions, the stock price, we don't have a need nor plans for immediate capital raise. We'll continue to, as we always do that we'll closely consider our programs and our spend going forward and look to provide updates in, you know, our quarterly call coming up. Now, the only additional comment I might make on that is that on that call, we also said that we expect our TAVALISSE and ITP sales to continue to grow, and that is still our expectation. Our expense level to be relatively flat. The gap between those two numbers will increasingly decrease over time. That's a pretty good place to be. It's good having a commercial product generating revenue on a quarterly basis and increasing. I think we're in good shape financially. Got it. Raul, could you please elaborate on that a little further in terms of your expectation for the peak sales in ITP in the U.S.? Sure. We haven't given guidance specifically. What we did say is that we expect growth the rest of the year. The impact of COVID is diminishing, giving us greater access. Dave's here, maybe I'll ask him to comment as well. Access to clinicians and in a good position to drive the business forward with this post-COVID reemergence. Dave, any comments? Yeah. I've got a few actually. A few important things that I'd like to say here. First of all, I think it's really important for everybody to know that today's results at all don't impact at all TAVALISSE's improved therapy for ITP. As a matter of fact, as you heard from Wolfgang, we saw encouraging data in patients in Western countries that was very consistent with the phase II data and the product's mechanism of action. In addition to that, you know, the safety profile from the FORWARD trial is very consistent with the existing fostamatinib safety database. I think that's gonna be very important to clinicians. We have been focused on spreading awareness among the heme-onc treaters and making sure we maximize access to TAVALISSE for patients. That's exactly why we expanded the sales force last year and gained preferred status on key national formularies. I think the team has done a great job executing as we're seeing continued growth in both prescribers and new patient starts. We'll remain focused on growing our business in ITP. For any clinicians who have questions on this warm autoimmune hemolytic anemia data, we'll be sure to respond to them through our medical affairs team so they can get the information they need to help them with their patients. Again, it doesn't change at all what we're doing. We're spreading awareness and in ITP, and we're maximizing access for patients. Got it. Thank you very much. That's very helpful. One last question, please. Has there been any off-label use such that, this data would, impact current sales? Thank you. Not in any meaningful way. Got it. Thank you very much. Thank you, Nolan. Thank you. Our next question has come from the line of Joe Pantginis with H.C. Wainwright. Please proceed with your questions. Hey, good morning, everyone. Thanks for taking the question. As you look forward, it might be too early to ask this question, but before you go to the FDA, do you have any relevant publications or clinical trials that you feel are most relevant to this case about geographical differences that you might present to the FDA? Wolfgang, would you like to answer that? I'll add a comment at the end as well. Ever since we've seen the data a few hours ago, we have started looking into this and there are some. There is some precedent for some trials. In fact, even with Eastern European high response rates, high placebo response rates contradicting the rest of the world results. There's a trial with spironolactone and a couple of other things which we are putting together and evaluating in much greater detail. We're in the process of doing it. The process is not concluded. It's not the very first time that this happened, and it's not the very first time that there has been a path forward in situations like that. Of course, we have to compare in great detail how that applies to our case. Again, we believe that the Western countries result is plausible and we are going to make the case. This is gonna be, you know, a discussion with the FDA and we'll have to put our best possible case forward and first of all, really understand the data completely before we make strong statements to regulators. Right. Certainly. Joe? Appreciate the comments. Thank you, Joe. Thank you. Our next question comes from the line of Gary Nachman with BMO Capital Markets. Please proceed with your questions. Hi, guys. Good morning. First, the differences you described regionally on patients having shorter duration of AIHA and on previous treatments, did you have any reason to think about that as part of the inclusion criteria for the study? Was there any evidence in the phase II that we could see these types of differences in the results with these different types of patients? I'm curious how much of a surprise that was to you. Augustine. Yeah. Well, you know, remember the phase II study was done. First of all, the phase II study was an open label, not placebo-controlled study, and it was conducted exclusively in the United States. Patients in the United States, which was confirmed in this trial, generally had you know, longer standing AIHA. They had a number of previous therapies. Now, you have to make an effort to enroll these studies. You have to find 100 patients, so you have to be geographically diverse. You know, that leads you to open the study up to Western Europe and also to Eastern Europe. In Eastern Europe, drugs like rituximab are less readily available. The patients that are out there are apparently less treatment experienced. Sites found the patients that, you know, that were recently diagnosed with AIHA and enrolled them in the study. Now, is that a surprise? I you know, I don't know if how anybody would be able to predict what precise patients would enroll in the study, other than saying, well, maybe biologics are less available in the Eastern European countries. This is how it turned out, and this is how the data played out. It gives us an opportunity to highlight the patient populations in the Western countries were clearly different from the patient population in Eastern countries and try to find explanations on why there might be a differential response rate in these patients. As I pointed out earlier, for early patients, they just might respond. That's a hypothesis. They just might respond to steroids better. It takes, you know, a few months until they reach their maximum response rate on steroids, which might be in part during the study, while other patients have maxed out on their previous treatments and don't have additional responses which we have achieved with fostamatinib. Again, I have to continue saying we have to do some analysis, look at all different subpopulations with different durations of treatment and things like that, and understand the data as much as we can. Okay. The opportunity, if we eventually get an approval, if we're so lucky to do so, and it is in patients that have had over a year worth of AIHA, that's a very good population. Okay. I have to ask this question, but, you know, could the geopolitical events in Russia and Ukraine have impacted the results in any way? I'm curious how many patients were specifically in those two countries. How could you have been completely confident with the validity of those results? You know, what measures did you take throughout the study that made you confident? How are you able to check so quickly and be comfortable that no mistakes were made, I guess, in all the Eastern European countries? Thanks. Maybe three questions there. Conflict in Ukraine, mistakes were made. How can you be confident of that? Any other issues in Eastern Europe? Wolfgang, you wanna- Yeah, sure. Well, your first question, did Russia and Ukraine have anything to do with this? My preliminary answer is no. We looked at the placebo responders. The placebo responders in Eastern Europe are the most confusing outcome, right? We looked where all those are from, and they are not from Russia, and they're not one patient from Russia and not one patient from Ukraine. They're from Bulgaria, Czech Republic. They're from different sites in different countries, not all one site or not all one country. They're from different sites and different countries. Russia and Ukraine, no, that's not the reason. You say, "Well, how confident can we say that there was nothing done wrong?" Well, you know, I mean, if you were with me, you would see the data, and then you have your checklist and ask the questions and you work yourself forward. As I said earlier, you check, you know, did the patient receive fostamatinib or placebo, or was there some mix up? No, there was no mix up. We looked at the PK data. Patients who were all supposed to be on fostamatinib had fostamatinib in the system. We look at central labs. If there may be a local lab, the central lab discrepancy just couldn't, there was not. We look at concomitant medication. Was there some undue rescue treatments, not that we can tell at this point and so on and so forth. You check box after box and say that this is. These are the obvious questions. Is there anything obviously wrong? At this point, I cannot say that anything was obviously wrong in the Eastern European countries. As we continue to look at all kinds of potential reasons, you know, we might find something. Right now, it's mostly really the different patient populations and baseline characteristics that is our key lead. We will continue to look and find out everything we can. Okay. That's helpful. Just lastly, I don't know if you specifically said this, but do you have a sense of how soon you could potentially meet with the FDA? I know it takes some time to go through all the data and get on their schedule. You know, do you think it could happen in the third quarter or before the end of the year? Just a rough estimate on that. Thanks. Yeah. I'd say fall is probably a good outcome, a good projection. You know what I mean? Ideally, before we meet, we have a really good case to make, and this is going to take a little while. I would say third quarter, before the end of the year, fall, something in that timeframe sounds about right. Okay. That's helpful. Thank you. Thank you. Our next question comes from the line of Kalpit Patel with B. Riley. Please proceed with your questions. Yes. Hey, good morning and thanks for taking the questions. I guess first, can you provide additional detail on the use of rescue therapies in this trial, maybe not just after week four but throughout the trial in each, the active and placebo group? Then if you also have the data by the geographical area, that would be useful. Wolfgang? Yeah. I mean, you've seen the numbers for rescue therapy being used. It's. I'm just gonna pull up the slides in the secondary endpoints. I mean, in general, as you can see in the Western countries, the fostamatinib patients are more free of rescue than the placebo patients. That's the opposite in Eastern Europe. You know, so it's that in Western, in the Western country, it goes in the right direction. It's not entirely surprising that patients over a treatment of six months at some point need some additional therapy. You know, the AIHA is sometimes getting a little better and sometimes it's getting a little worse, and sometimes whatever medication you're on is not sufficient, and then you need to adjust any dose of something, and that's rescue therapy. That's not super surprising. In the Eastern European countries, we are very carefully looking at rescue therapy. There was not something obvious that there was irresponsible use of rescue therapy or something like that. If you look over 24 weeks, as you know with the primary endpoint, if you had achieved response status, say in the first 12 weeks, and then at some point you get worse and get rescue therapy, you're still a responder. You will still count as a responder. That's another hypothesis of things that we're looking into, how long and when exactly did rescue therapy happen. That's on the list of things to look into, but I cannot give you every patient with rescue therapy on each of these groups at this point in time. We certainly will continue to look at that. Thank you. Kalpit? Okay. That's helpful. Thank you. I just had one additional question. I'm looking at the, you know, the row above that, the change in mean hemoglobin from baseline to the end of treatment in your Eastern European data set. I guess, can you speculate why, you know, that mean hemoglobin change is so small in the active arm, you know, despite these patients being less refractory, relative to the patients enrolled in the other, geographical regions? I started with the Western countries, so small. That data point is influenced a little bit by dropouts. If a patient drops out, which I have shown you happens more in the placebo group, then there is no subsequent hemoglobin measurements, right? Therefore, like a patient who does poorly in the placebo group is not in the study anymore, so then the mean for the overall group is sort of going up rather than being dragged down. That's if you ask why is the difference not that big in the Western countries. It's influenced by dropouts. In the Eastern European countries, yeah, we have those few placebo patients who are doing fine, and their hemoglobin levels are reasonably high. Therefore, you know, the higher rate of placebo responders in the placebo group in Eastern Europe does correspond with the higher hemoglobin level in the placebo group in Eastern Europe, as well. Okay, thanks for taking the question. Thank you, Kalpit. Well, one thing to say is we look forward to sharing the data with FDA, but also obviously publishing this result more fully once we've done some further analysis of this. Got it. Thank you. Thank you. There are no further questions at this time. I would like to turn the call back over to Raul Rodriguez for any closing comments. Thank you, and thank you for your interest and participation in this call. We very much appreciate it. You know, it's always a challenge more than you expect in pharmaceuticals. We believe the product does have a benefit in these patients. We believe this data helps us make that case. We will make that case after further investigation. I would go to the FDA. It's similar, not that different actually from the case with ITP where we had one trial work, one trial not work, and we were able to make a compelling case, take it to the FDA, and they agreed to approve the product and that indication successfully. I think it helps the case that there is a tremendous medical need in this sector. These patients are really many of them in desperate straits sometimes. A product like this in this rare orphan disease is something that sometimes is a challenge, small numbers, et cetera. We will work hard on getting this across the finish line, just like we did for ITP. Those patients got a product that I think is tremendously helpful for them, and I think these patients deserve no less. Thank you for your support. Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.