Faye Feller: Sure. Thanks, Chip. So regarding the ODAC we’ve contracted, we’ve been, as you know, is common in industry prepare for an ODAC ahead of time. So we even before the announcement, or the communication from the FDA, we have been working with accredited — like a very well known vendor, who specializes in ODAC preparation in order to anticipate or you gameplan any types of questions or issues that may be of relevance. Overall as with most ODAC, it will be come down to a clinical question of risk versus benefit. And other than that we don’t have any further details.
John Scarlett: Yes. Thanks, Faye. I think I’d like to make a couple of other points about the ODAC. Just to remind people we were told that the FDA is planning an ODAC, but we don’t know if that will actually occur. There’s historical. There’s historical information about other products in which ODAC had been planned. They’ve actually been scheduled and they’ve been cancelled last minute. So I think we’ll just have to wait and see on that. We often get a question, Craig, about when did the most ODACs occur? I think in general, our research shows that they occur four to six weeks before the PDUFA date something like that. And I think the other comment is that we have a variety of consultants. So as well as the consultant that Faye was describing who is a very specialized ODAC and advisory committee, consultant.
We have other broad, regulatory consultants. So I think we feel like we will be very prepared through this process for whatever may come and as we’ve commented in the past, and she commented today in her prepared remarks, I think we look forward to discussing the opportunities for treatment with imetelstat in the space.
Operator: We’ll go next to Kalpit Patel at B. Riley.
Kalpit Patel: Maybe first, related to an earlier question. I know we have the updated guidelines here. But I’m curious if we have a sense of how reblozyl is being utilized in the real world based on your engagement with KOLs. Is a preference to use reblozyl only for RS positive patients in that frontline, ESA naive group, or and does that utilization, at least what you’re seeing so far? Does it look consistent to the survey data that you highlighted?
John Scarlett: Anil, that’s definitely for you reblozyl in the real world and is it consistent with what we’ve seen from survey data?
Anil Kapur: Thank you for the question, Kalpit. I think, our survey data which focused on the second line space, you clearly saw where things are, but when we talk to physicians and start to dig into frontline use, what we see clearly is both PSAs and luspatercept to be part of the treatment paradigm when we are speaking to physicians, both academics and community. I think you will see a preference for RS positive patients heading towards luspatercept. But there are also important nuances that need to be kept into effect, especially serum equal levels greater than 200 typically favor luspatercept, less than 200 PSAs are also very much in play. And then for ESA, ineligible patients, commands, as you know, Kalpit, did not study those patients in particular with that study, but they do have a broad level, but physicians continue to side unmet need for that patient population.
From our perspective, I think we see both. I think the degree of adoption depends upon dissatisfaction or satisfaction DSAs, in particular prescribers experiences, and we will see both these drugs be used. But it will not be a replacement or a displacement issue for ESAs to the best of our judgment today, as we go forward. And these patients need a lot of new treatments, and imetelstat does get referred as well, as part of the future treatment paradigm when we show them all the data. So hopefully, this will answer your question, Kalpit.
Kalpit Patel: Yes. That’s helpful. Thank you. And then, Chip, you mentioned partnering earlier, I guess any more color on, how you’re thinking about partnering could be useful to investors, maybe is it just for ex U.S. territories, or both U.S. and ex U.S.?
John Scarlett: Sure, Kalpit. Thanks. Yes, look, partnering is part and parcel of our business. It’s an arrow that every company would hopefully have in their quiver. And it’s a conversation that needs to continue to develop and mature as you move closer and closer to potential approvals and subsequent commercialization. So I think that we have always been open to partnering. What we commented on today was specifically around European commercialization. And I think that, of course, we have the goal to bring imetelstat to patients in that marketplace as efficiently and as effectively as possible. And given that the MAA is now under review, and we have a better feel for timing, I think that we tried to point out that the earliest potential approval would be in quite late 2024.
And that means a European launch would be potentially in 2025. So we’re going to continue to evaluate our strategic options, which include not only partnering but also self-commercialization, as we go into and progress through 2024. And I would hope we would be able to give an update we expect to give an update later in 2024, in that specific part of the world.
Kalpit Patel: Perfect. And one last question. Do you have this abstract that shows the differences in overall survival between the responders and non-responders for transfusion independence? I guess, have you done any sort of early analysis for your own patients in IMerge study? And whether that data is consistent with what you’re showing in that claims data from the [indiscernible]?
John Scarlett: Well, I think that claims data first and foremost, I think that claims data is what I would call very mature data. And it was a large number, I don’t remember the exact ends, but it is very large number. I think the purpose of that study was to provide additional insights across various platforms and across various drugs as to the supporting the value of transfusion independence. And I think that that’s been a staple of belief amongst most practitioners and also, for that matter, academics. But I do think that since we interact with claims databases all the time, in doing our own assessments, we thought this was really valuable and interesting, and collaborated with [indiscernible] and the Moffitt to produce — to help them analyze these data and make this presentation. So I think it stands on its own, honestly as a overview of the value in this marketplace of transfusion independence — achieving transfusion independence. Thanks.
