Tara Bancroft: This is Tara on for Tyler. So I know you mentioned a little bit about timing. But specifically, what we’re wondering is, once the COVID strain is selected for the fall and winter season next month, how long approximately do you think it will take to finalize the commercial contracts in the U.S. and abroad? And then separately outside of the U.S., does the recent announcement regarding the ongoing negotiation with Pfizer and Europe actually create an opportunity for you guys to perhaps drive a larger contract in Europe than previously anticipated?
Arpa Garay: Thank you for the question. Your first question around timing of contracting in the U.S. while we are waiting for the final variant strain to be selected in the middle of June, we have already initiated contracting conversations based on an FDA-selected variant. So as I mentioned previously, we do anticipate seeing some of these contracts being signed over the next several weeks, leading into the third quarter. So it will be sort of an evolving time line based on the customer. From an EU perspective, we’re encouraged by the news that the EU is in renegotiations with Pfizer. For us, the signals that the EU likely does not want to rely on one sole supplier. And we also are encouraged that the EU does recognize the value of the effectiveness and safety of our COVID-19 vaccine.
So we continue to work with them to see how we can help protect the 140 million people or so in the EU, who are at high risk of COVID infection. And as we get updates on EU negotiations, we will be sharing those as well.
Operator: Thank you one moment for our next question. Next question comes from Michael Yee with Jefferies. Your line is open.
Michael Yee: Two areas I wanted to ask on PCV or shall I say, INT cancer therapy. Stephen, you’ve talked and mentioned there in the slides around time as well as breakthrough designation. And I think you mentioned that you do have a discussion with FDA around your recent data. Can you just talk to the scenarios around a potential accelerated approval, the argument that you have to bring this to patients sooner or do we really have to wait years to run the Phase 3? Talk a little bit about how you feel about that this year. And then the second question, I think, is also important with regard to RSV. Obviously, we’d love to see a diversification of revenues. This could be coming next year. How do you see your revenue opportunity in 2024? Is that a payer battle or a couple of competitors out there, where is your advantage? And how do you see yourself with market share and revenues next year?
Stephen Hoge: Thank you, Mike, for the question. I’ll take the INT one. So Look, I think it’s obviously still early in this discussion about what it will take to bring this notion forward to patients. And even in the Phase 2 study, while the data is really exciting, it’s probably premature to say that it’s sufficient for — at this point for proceeding directly to accelerated approval. But there are conditions we think over the next year — or couple of years that could lead to that being an appropriate thing for us and regulators to consider. In the short term, look, the data is still maturing. We still haven’t put out the distant metastasis free-survival data. We’re going to be doing that at ASCO. We’re obviously excited to share that data, and it starts to just build that more complete picture and DMFS because it looks at visceral lesions does start to look towards perhaps some of those more — the severity of those relapses that are happening.
We have additional biomarker data that’s coming through in that ASCO presentation as well. And both of those data sets are dealing with the initial analysis, which was 40 events. But I’ll remind you, we have an analysis at 51 events, which we think will be when these curves are substantially more mature. Obviously, we haven’t crossed that yet. And when we do trigger that 51 of that analysis, we will update the RFS curves. We’ll update the DMFS curves. We’ll obviously look at statistics around that. And it will be a point in time for us to understand, let’s say, with more than 2.5, maybe 3.5 years of follow-up in total median follow-ups on that study. What do the overall curves look like? What are the hazard ratios? What do the statistics look around that?
And then what more have we learned about the MLA from all of the ongoing biomarker work that we’ve done. So that richer data set I think, is really what we are waiting for to see. There’s a second piece of this, too, though, which is that. Any consideration of an accelerated approval, whether it’s for INT or just more generically, increasingly, it’s going to depend upon whether or not you have initiated the confirmatory studies and that’s appropriate. Because we’ve all seen how initiating substantially enrolling the confirmatory studies actually helps make sure that, that answer comes quickly and that accelerated approval can either be converted to a full approval or be adjusted as a result of those confirmatory results, and we’re very attuned to that.
And so our primary focus right now, while we’re waiting for the data to mature from the Phase 2 is to make sure that we stand up that Phase 3 study and enroll it as fast as possible. I think the conditions under which we might consider in partnership and discussion with regulators pursuing accelerated approval would really be at some point in the future when that Phase 3 study is well on the path towards being enrolled obviously not read out yet, but well on the path there being enrolled and where a lot of the other data I had described had matured and continued to show a really compelling pace for the potential benefit here, perhaps even in patient populations they are at higher risk from a stratification perspective as we were sharing in some of the data today.
And that those — that complement the factors would trigger an opportunity to say it’s time to bring this medicine to patients in an accelerated way while waiting for the confirmatory read out. So premature. All of those things still have to happen. So that’s why right now our focus is get that Phase 3 started, get it enrolled and continue to follow this really intriguing story in the randomized Phase 2 study.
