Tom McCourt: But we’re not seeing a dramatic increase in our investment. I think this is maybe a refinement of our marketing mix. I mean there’s no question. We’re running a number of pilots, digital pilots right now, certainly sales pilots right now. And we’re taking a critical look on the whole Medicaid exposure piece, which has to be part of the equation with regard to where we’re going to focus our activity and investment. So, I think we’re very pleased with what we’re seeing as Sravan said, but we certainly are going to be very, very disciplined with regard to how we invest our money at this point in the life cycle.
Sravan Emany: Mike?
Mike Shetzline: Yes. So yes, for the apraglutide for the Phase 3, I mean, honestly, we’re clearly 110% focused on the March top line results and very much committed to that in delivering that. So, we all can understand where we are. And then, of course, we still have a launch opportunity for 2025, which we’re focused on. And then in between that, that will all fall in as we see the date in March.
Operator: Your next question comes from the line of Tim Chiang of Capital One. Your line is open.
Tim Chiang : Mike, I wanted to ask you a couple of questions just on like obviously, there’s not going to be any head-to-head data with apraglutide and type and Gattex. But just looking at the Gattex label, obviously, that drug was approved a long, long time ago. Their primary efficacy endpoint with is really a clinical response measurement. And I wanted to get your comments on it because obviously, let’s assume you have good data in March. But how would you sort of — I mean will you provide data on the secondary outcome measure of at least a 20% reduction of parental support volume from baseline at weeks 20 and 24. Just sort of as a relative comparator to Gattex.
Mike Shetzline: Yes. Thanks, Tim. So, you’re exactly right, and I kind of alluded this into my other comments, but the Gattex program had a responder definition. The responder definition required a 20% reduction in parental support volume to be a responder. And that actually translates quite well to the end point of the reduction in at least 1 day of per week. In fact, you may recall, I don’t know if you’re aware, but at the Gattex Advisory Committee, it all came down to that from the agency is one day a week meaningful? And does this sort of 20% relate to that, meaning a responder definition. And it was a key discussion point and clearly, the advisers agreed and it ultimately got NPS approval for Gattex and short bowel syndrome requiring parenterol support.
So, it’s for us, it translates into that one day off. To your point, we have a 20% reduction endpoint, but it’s not one of the key secondaries that’s statistically accounted for because it’s also in the regulatory discussions taken a second seat to the parenteral support volume reduction at 24 weeks as well as the one day off end why, and that’s how the discussions have gone with the agency. But they do very much correlate whether you take the relative change from baseline or percent change those volumes do translate pretty well. And if you look CapEx primary was a little nuance to is the percent change. They didn’t use the responder definition CapEx did. But if you look at the data, it actually translates pretty well across the two studies even 10 years apart, which I felt quite interesting given the nature of a short bowl syndrome with intestinal failure.
Tim Chiang: Okay. That’s helpful, Mike. And I guess, just the common ground between the data that we have with Gattex and Glepa is that they have obviously shown basically about a two point or 2-liter reduction per week in parenteral support needs, right? I mean and that’s sort of that’s like the absolute delta over placebo. So, I just wanted to make sure that sort of — I mean, if you can get that similar type of efficacy, that would be considered a win, Mike?
Mike Shetzline: Yes. Well, I think right now, I mean you’re getting to the granular volumes. But honestly, right now for us, the win is going to be the statistics around the primary endpoint. I mean because that’s how it’s going to play forward with the agency productive, and that’s what we’re committed to delivering. But we certainly will have all that data, Tim, as things roll forward, just like it happened with the Gattex and the Glepa programs. A lot of those more nuanced volume data’s do come out later because the primary top line data usually sticks to a statistically relevant endpoints from a first run perspective, and then we’ll have multiple scientific sessions, which we’ll continue to roll out data to inform us of the study outcomes.
Tim Chiang: I mean, is it possible that some of this more specific data might be able to be released at like an upcoming medical conference like DDW? Or do you think you won’t make the cutoff?
Mike Shetzline: Well, the abstract deadline for this DDW is for us last December. So that’s kind of a — there’s obviously the fast track point. But the point is for the top line, we really stick to the statistically relevant endpoints. So, they are going to — there’ll be a lot of data coming later.
Operator: As there are no further questions, I would like to thank our speakers for today’s presentation, and thank you all for joining us. This now concludes today’s conference. You may now disconnect.
