Robert Blum: Okay. No I understand. Thank you. I’m going to ask Andrew to speak to some of this but please understand that absent the data right now these are abstract scenarios that we’ve contemplated in market research. And once we have the data, we’ll be able to do more refined market research, and ultimately as we may propose a REMS this is something that is going to be achieved through interactions the sponsor with FDA. So all of this is subject to still a great deal of uncertainty until we have the data around, which it’s based. But we do have certain expectations as we have seen REDWOOD data as we’ve seen FOREST data. And as we’ve understood what’s behind the REMS for the other cardiac myosin inhibitor we have a view to what might ultimately be enabling of a lesser REMS, but that’s still quite speculative as you can imagine at this point in time. Andrew, can you speak to how you’ve approached this from the market research standpoint?
Andrew Callos: Sure. So, I guess, there’s two important things to understand. One is, we probably won’t have that much clarity in terms of exactly what a REMS program is going to look like early in the review process. That’s something that we proposed to the FDA. But relative to our patient support services, independent of what the REMS will look like. There are certain elements of patient support we’re going to offer. So we know we’re going to offer things like patient assistance and co-paper. We’ll look at echo reimbursement. We do we’ll help with benefits verification education on disease states. So there are certain things that we know around minimum and that we’re going to do. There’s other things that based on the complexity of the REMS that we’ll do as well.
Our assumption going into the planning is that we’re going to assume a complex REMS with all elements and it’s a lot easier for us to simplify or back down from that once the REMS program comes into view because when it does come into view it’s a negotiation as you’re negotiating a label near the end and we would not have enough time to react. So hopefully that gives you a sense of how we’re thinking about it.
Robert Blum: And just to add one more comment. If you read the summary basis of approval, there’s a lot that one can learn about what the FDA was seeking to accomplish in putting in place the REMS program that does exist today. And we’ll obviously be conditioned based on that prior knowledge to know what we need to glean from the evidence from FOREST and SEQUOIA in order to hopefully enable something that is different. But ultimately, that’s something that comes down the road following the acceptance and the review of a new drug application.
Jason Butler: Okay. Thank you.
Robert Blum: Thank you.
Operator: Thank you. And our next question will come from Srikripa Devarakonda from Truist Securities. Your line is open.
Robert Blum: Good morning.
Srikripa Devarakonda: Good morning, Robert and the team. Thank you so much for taking my question. And really looking forward to the data in about a couple of months hopefully less than that. I have a question about MAPLE trial. You talked about enrolling patients that are naive to therapy as well as those who were on background therapy but withdrew from it. Can you remind me if there’s any restriction in terms of how long these patients could have been on therapy symptomatic and on standard of care? And how that featured into how the trial was powered?
Robert Blum: Very good questions. I’ll turn to Fady please.
Fady Malik: I’ll ask Stuart to answer since he discussed MAPLE in his section. But in general, patients could have been on beta blockers for any length of time as long as they could be withdrawn they were considered in certain classes. And depending on the length of time I’ll let Stuart elaborate please.
Stuart Kupfer: Yeah. Thank you for the question. The concept here was to evaluate aficamten as first line use or as an optional monotherapy for patients who have been treated with standard of care for let’s say a number of years. And so we sort of subgroup these patients into one at either naive to beta blocker therapy or no longer receive in beta blocker therapy or on beta blocker for a short period of time versus those who have been treated beta blockers or standard of care for more than a year. And that’s sort of the breakdown and the strategy for evaluating aficamten monotherapy as first line versus again a possibly a superior option versus standard of care as the monotherapy for patients who have been on standard of care for an extended period of time. So the study is designed, of course, to evaluate the potential for superiority of aficamten monotherapy versus beta-blocker monotherapy in either of those subgroups of patients.
Q – Srikripa Devarakonda: Got it. Thank you.
Robert Blum: Thank you.
Stuart Kupfer: Thank you.
Operator: Thank you. Our next question will come from Jeff Hung from Morgan Stanley. Your line is open.
Robert Blum: Hi, Jeff.
Unidentified Analyst: Hi. Good afternoon. This is Catherine on for Jeff. Thank you so much for taking my question. You mentioned previously that physicians have indicated their interest and excitement in aficamten. We want to ask you either your reader to-date or any feedback that you received what aspects of aficamten profile is the physicians may be finding most compelling?
Robert Blum: So Andrew, may I ask you to respond to that please?
