Ahu Demir: I have one last question, if I could squeeze in one more. Following up on the confirmatory study, as the discussions continues with FDA, when do you plan to disclose or report additional clarity, what you will be doing? Are we expecting to see that after top line data or before? Any time line that you could communicate with us?
James Caruso: They would clearly be — great question from a timing perspective. They would clearly be post top line data.
Operator: Your next question comes from the line of Jason McCarthy of Maxim Group.
Jason Mccarthy: You briefly touched on this, but maybe you can provide some additional color on how the top line data may be presented, meaning would you stratify the data by CXCR4 and MYD88 mutations as well as patients, even though they’re third line, that 30% or so that never got a BTK, with the idea that maybe you could make certain claims in a potential label?
James Caruso: Before I turn it over to Andrei to respond to that, I will share that our patient population is a relapsed/refractory population, obviously, across the board. These are patients that have been treated with multiple lines of therapy. And so it is a difficult and challenging-to-treat population. And when you think about a label, obviously, our clinical trial was designed for a label for third line or greater. Based on the patient population we have, I think it’s fair to say that we could engage the FDA and potentially expand that label to relapsed/refractory versus third line plus. And so Andrei, any comments relative to…
Andrei Shustov: Yes. Thank you, Jim. And Jason, this is excellent question. And to your point, we absolutely are going to be looking at grainy details of our data as we should, remembering that with target enrollment of 50 patients, once you start splicing this population, it’s going to get really grainy, and we will be very careful making any definitive conclusions if we have single-digit number of patients. But what we are committed to is certainly delivering top line data results on our primary and major secondary objectives. But all the exploratory objectives will be looked at, and we would be deciding real-time whether, first, we detect a signal or it’s meaningful and worth disclosing. But again, our focus is really on the primary and major secondary objectives at the time of data disclosure.
Jason Mccarthy: And last question just briefly, just from a safety profile aspect along with that top line data, would you mention lack of bleeding risk? The bleeding became issues, obviously, with WM generally, but the BTKs, when that second one was developed, that became an area of investor focus. Would you take the opportunity to highlight a cleaner safety profile around your drug, even though it’s a different category than the BTK?
Andrei Shustov: Thank you, Jason. Again, another very important question. And we believe that we are certainly well positioned in comparison to, as you mentioned, BTKi’s in terms of specifically bleeding hematologic profile for a couple of reasons. Our hematologic AEs are expected, predictable, manageable and recoverable in all the patients. And based on very short duration of treatment, are expected — we expect that patients will need very temporary support as opposed to continuous therapy with BTKi’s. And I will also mention, mechanistically, the issue that you brought up, bleeding with BTKi’s goes to mechanism of action and not just cytopenias. We do not have mechanistic — mechanistically, we do not have reason to believe that bleeding will be functional.
And with proper support care for cytopenias, we should not expect any clinically meaningful or dangerous high-rate bleeding complications. And again, I truly believe that we will be positioned very well from a duration standpoint and mechanistically to — against bleeding signal that was detected with BTKi’s.
