Operator: For your next question. Your next question comes from the line of Luca Issi with RBC Capital. Your line is open.
Luca Issi: Oh, great. Thanks so much for taking my question, and congrats on the progress. I have a quick one on HELIOS-B. I think there’s a few docs out there that are convinced that actually the drug is making an impact for their patients with ATTR cardiomyopathy, but they are just worried that this trial is not long enough to actually show a convincing separation of the curves. Is there a scenario where you can amend the protocol so you don’t read out the primary endpoint when the last patients reach the 30-month mark, but rather after a pre-specified number of events? Any thoughts there? I much appreciate it.
Pushkal Garg: Yes, Luca, I think, you know, there’s, and first of all, it’s great that you’re getting that sort of feedback. We’re obviously encouraged overall by the profile of vutrisiran and that we’re seeing from patients out there. In terms of the study design, I think we’ve a, I’ll just remind you, we have a track record of working in this space for quite a while and executing successful studies. Our teams have gone through and we feel very good about the design of the study and the execution of this study. As a reminder, we’ve got variable follow up for 30 to 36 months. And this study builds upon the success and what we’ve seen in terms of encouraging data coming out of APOLLO-B where we saw positive impacts on functional endpoints, quality of life, evidence of potential delays in disease progression and favorable impacts on echocardiographic parameters, technicians, and there’s a lot of positive data there.
And HELIOS-B is twice as large and about three times as long. So we feel good about the design and execution of that study, and we’re not planning at this point to make any changes.
Yvonne Greenstreet: Yes, spot on Pushkal. I mean, right now we’re focused on robust execution and bringing this home and sharing results with you in early 2024.
Luca Issi: Got it. Super helpful. Thank you, guys.
Yvonne Greenstreet: Next question,
Operator: One moment for your next question. And your next question comes from the line of Jessica Fye with J.P. Morgan. Your line is now open.
Unidentified Analyst: Hey, good morning. This is Jail for Jess. So two questions from us on the sNDA of ONPATTRO, in the case that the FDA will request any new data, or in the case that you might want to send more data to the FDA, do you expect any type of PDUFA extension because of the new data submission? And then secondly, we know that the cardiovascular outcome data from trial will be available in July. So just curious, would you be watching for the data from the CM and if any thought you can share with us regarding the kind of potential impact on the tribute data on your thinking of the change in patient population and anything along those lines? Thank you very much.
Yvonne Greenstreet: Two questions for you really here, Pushkal. One on the sNDA was on ONPATTRO and requirement for new data and potential extensions, the data and then I think some questions around our perspectives on cardiomyopathy outcome study.
