George Yancopoulos: And I think there is nothing specific to either pozelimab or aflibercept about the data. This has to do as Len said with general manufacturing processes and operations at the Catalent manufacturing facility, particularly with this one manufacturing line.
Leonard Schleifer: Hey, that’s a very good point, George. So that’s why the single pre-approval inspection applies to both products. It wasn’t the product specifically, it was the processes and validation on the line that fills the two products. So one remediation satisfies both, all the data and information that is being submitted on a rolling basis, the last piece comes in, in the middle of August, the FDA is aware of this. They’ve told us in writing that they will strive to do that as expeditiously. If they get it done before the end of the PDUFA, an original PDUFA clock, that’s great. If they don’t, they’ll consider an amendment that will set the clock back three months. But notwithstanding that three months, they’ve told us that they will continue to prioritize our review. So we’re very pleased and we’re working very hard. Catalent is working very hard, the FDA is working very hard, everybody wants this done properly and finished and properly remediated.
Ryan Crowe: Okay. Next question please, Shannon.
Operator: Our next question comes from the line of Tim Anderson with Wolfe Research. Your line is now open.
Tim Anderson: Thank you very much. I have a question on the Vabysmo. So Roche at Q3 said they’re capturing 30% of treatment-naive patients which seems like a quite high figure frankly. And then they said afterward, that it’s not the extended dosing that’s driving this as much as it is the better drawing that they say docs or seeing with their product. I’m wondering how those comments kind of line up with what you’re seeing play out in the US market. Thank you.
Marion McCourt: Sure. So, Tom, I will comment on our EYLEA performance. And as I just shared with you the performance in the quarter was strong, certainly we see EYLEA steadily as the standard-of-care in the anti-VEGF category. We continue to capture not only naïve-patients, but also another big source of business is switch patients from Avastin. Obviously, the other branded competitors are smaller in market today. But I would say that beyond your comment, probably best to get more clarification from the individuals who are commercializing faricimab in the market. But certainly, I do want you to know that we are seeing continued strength in EYLEA performance and obviously very much look forward to having the potentially game-changing opportunity of bringing aflibercept 8 milligrams into the marketplace and where the profile of efficacy, safety and durability has so many KOLs and prescribers excited based on what they’ve seen recently in the clinical data presented at ASRS.
Ryan Crowe: Thanks, Marion. Next question, please.
Operator: Our next question comes from the line of Chris Raymond with Piper Sandler. Your line is now open.
Chris Raymond: Thanks. Just maybe another market-related question. So I know these extended dose therapies have benefits in and of themselves on the face of them. But there’s been some decent level of market chatter around docs, looking to free up injection capacity specifically to make room for geographic atrophy patients and specifically with the Apellis drug. Just maybe curious how widespread was that notion before the Syfovre safety issue. And now with the issue have you noticed a discernible shift among docs who we’re talking about that? And then maybe a related question, you guys have talked I think about an early effort of your own in geographic atrophy. Clearly, the market is sizable, when could we expect to hear more about that effort?
Marion McCourt: So let me share first in terms of the market dynamic. I think the most exciting thing and most important thing about aflibercept 8 milligram is it gives prescribers for all of their patients whether a naïve-patient, a patient currently on EYLEA or a patient on another anti-VEGF category product, the opportunity to decide if that patient is a candidate when we launch and when we have an FDA approval, is the patient is a candidate for aflibercept 8 milligram, that does have benefit to the patient and prescriber and potentially to the office capacity and patient flow. I think it’s premature to comment on the category that we’re not directly involved in. We are though very focused on making sure that we are ready for launch and certainly at the proper time, educating all stakeholders on aflibercept 8 milligram once we have an approval.
George Yancopoulos: And in terms of our own efforts, as I’m sure many are aware we’ve been very active with what we feel are very innovative approaches in the complement blockade field. And we believe that we may have an approach that may allow potential treatment in these retinal diseases. While avoiding some of the very concerning adverse events having to do with issues like inclusive vasculitis and so forth, and you’ll be hearing much more about those efforts in the short-term.
Ryan Crowe: Okay. Thanks, Marion and George. Shannon, please move to the next question.
Operator: Our next question comes from the line of Carter Gould with Barclays. Your line is now open.
