Luca Issi: Oh, great. Thanks so much for taking my questions. Maybe a very quick one on RSV. I think the last press release actually cited May 12th as the PDUFA date. While today, you’re simply saying the initial regulatory approvals is in the first half of 2024. So is there anything to read to it, can you just confirm that the PDUFA date is still May 12th, which is actually the end of next week? And then maybe second, on IP, can you just comment on the recent decision by Judge Goldberg to rule in favor [ph] of Arbutus or you’re looking on a particle, our understanding, this can have pretty material impact on both prior and future sales of COVID, so again, any thoughts there, much appreciated? And then super quickly on INT. Steve, what’s holding you back on starting the randomized trial intended at cancer into metastatic studies, I thought the data at ACL was pretty impressive so any thoughts there, much appreciated? Thanks so much.
Stephen Hoge: Great, thank you for the questions. I’ll take this first from the third very quickly. So on the question of RSV, we continue working towards the same PDUFA date, and there’s no change to that. As you know, there’s a lot of work and around the clock work by ourselves, obviously, and folks at the agency. And so we’re hopeful that, that happens as planned, but if it takes a little bit longer, at the end of the day, what really matters is the — meeting, but there’s been no change to report. So don’t read anything into that. As far as the INT question, on head and neck, I appreciate the question because we are also obviously enthusiastic about that data. However, our partner, Merck and ourselves, we have not yet decided where that fits in the priority of other indications, pathologies, and opportunities we’re pursuing.
As you’ve already seen in the past year, we’ve stood up a very large number of study. And we’re just trying to pace ourselves. And so it will take us a little bit of time with our partner, Merck to determine what the next steps are in head and neck. And at this point, we do not have an update on it.
Stéphane Bancel: Thank you. I’ll take the IP questions. I mean as you know, our COVID-19 vaccine technology, including our lipid nanoparticle delivery system is the result of independent research and development. We have a strong belief that our technology does not impact on the patent asserted by Arbutus. We are confident in our position, and we look forward to presenting our case and trial next year.
Luca Issi: Thank you.
Operator: Our next question comes from Jessica Fye with J.P. Morgan. Your line is open.
Jessica Fye: Hey guys, good morning. Thanks for taking my questions. I had a few here. So for INT, I know you mentioned you can’t comment on when you expect to complete the manufacturing scale up. But can you provide a status update on where you stand with that today and the number of patients you can support right now as well as where you want to take that capacity once you get to the end of this 3-phase scale-up process, even if you don’t put a timeline on when you’ll get there? Next one is coming back to flu, can you just refine a little bit when the 1083 immunogenicity data will be available and maybe elaborate on how the combo data play a role in the regulatory tox on 1010, I thought you previously said these products could stand on their own and that you might not need 1010 approved to get 1083 approval, so now wondering kind of why 1083 might factor in for 1010?
And then lastly, on CMV, can you remind me how the risk of CMV and pregnancy compares in seropositive versus seronegative individuals, I’m thinking from a commercial standpoint, how you weigh the strategy of pursuing vaccinating everyone versus just seronegative people? Thanks.
Stéphane Bancel: Great, thank you for the questions. I’ll start with the INT question on manufacturing, then Stephen can add. So we have not provided some capacity numbers of the factory in Marlboro. But of course, as you can assume, we know the size of the melanoma market. And we know our stronger data. We have plenty of people benefiting from the Phase 2 data. So we’ve sized the plant accordingly, as you can imagine. But also we are building the plant of care because, as you know, Stephen and his team and his colleagues are running a lot of studies. So this is not a platform in [indiscernible] INT. Again, from a manufacturing standpoint, we don’t care which cancer is in terms of organ because we use genetic information to design an individual product for every human being.
So basically, we bought a plant last year that was kind of a big building finished, saves us time to market. Obviously, we don’t have to get the permitting and build the building. And so the team since then, that is now more than a year ago, has been working actively to get the plant ready. And the plant we will reviewing in modules inside the building. So basically, we’re going to launch with the first module of manufacturing capacity. And then — and one day maybe we do an opening of a facility like we did for Norwood [ph]. You will see that there’s another empty space left behind, which has also a very quick ramp-up because the [indiscernible] system has been set up for the entire plant. And so then you just add modules as you go. So we’ll be able to scale very quickly as we get more indication available.
But again, we’re aware of the melanoma number of cases. And so the plant will be sized so we make sure we can provide products to patients. Stephen?
Stephen Hoge: Thank you for the clarifying question on flu. So let me just start by saying that independently, we are looking to submit both the flu program and the flu COVID combo program. So that’s 1010 and 1083. Obviously, we need to see the 1083 data, and we’ll announce that when we have it. The question on the timing of that data, it’s imminent. And so in the coming quarter, we expect to be able to share that update. The point about interdependency, I suppose, is just more about sequencing of those submissions and in some places and some regulatory geographies, obviously, you can’t stack them on the same day, if you will. There’s a logical sequence and what we will want to assess once we see the 1083 data is our regulatory strategy as well as our preparation and delivery of data for the submissions to determine which one will go first or second.
