Joe Fletcher: Thanks, Tim, for the question. We’ll go to Dan for this.
Dan Skovronsky: Yeah. Maybe I’ll answer the second part of the question first, which is around, why did the FDA issue the CRL. I think that the FDA regulations actually suggest that FDA should list all deficiencies in the CRL. We were pretty explicit copying some of the FDA’s own words here to investors about what was in the CRL. It didn’t discuss issues like ARIA it was focused on the 12-month exposure. So nothing further to speculate there. I think your question on rates of ARIA-E and ARIA-H comparing across drugs is a complicated one. We did this head-to-head study against aducanumab. I think it’s important to use studies like that to compare rates of ARIA, because we’ve learned that grades of ARIA are highly dependent on the type of patients who enroll the stage of disease and underlying pathology, baseline characteristics of their brain scans, which are different across lecanemab trials and genetimib trials, as well as exactly how you do the MRIs and read them.
So I’m personally not going to get worked up about rates of asymptomatic radiographic-only ARIA in any drug. I don’t think anyone really understands what that means. What we should be focused on though is rates of symptomatic ARIA. So patients who have ARIA that turns into something they experience, not just a radiographic binding and particularly rates of serious adverse events resulting ARIA. We know that in some patients ARIA can be dangerous even fatal as we’ve seen from lecanemab experiences. So that’s what we’ll be looking out for. I think we still have all the caveats about cross-trial comparisons here, but it’s a bit easier to compare those symptomatic or serious events. I think in TRAILBLAZER-1 our numbers were very similar to other members of the class.
In TRAILBLAZER-4, the numbers look very, very good for that. And we’ll wait and see what we have in TRAILBLAZER-2. The level of concern over that is not high.
Joe Fletcher: Thank you. Lois, next question.
Operator: The next question is from the line of Terence Flynn from Morgan Stanley. Please go ahead.
Terence Flynn: Hi. Thanks so much for taking the question. Maybe a two part one for me. I guess first on Mounjaro manufacturing. I was just wondering if you can tell us if the FDA has completed the inspection of your new North Carolina facility yet. And then the other question relates to tirzepatide for obesity. I was wondering if you’ve had any initial payer conversations yet, and if you’re planning to use a priority review voucher for that filing? Thank you.
Joe Fletcher: Thanks, Terence. I think I’ll hand over to Anat for commentary on your manufacturing question and then to Mike on the question about whether there’s been any payer conversations on obesity.
Anat Ashkenazi: Terence, to your question on the RTP side North Carolina, it’s progressing on schedule as we had planned. We can’t comment on specifics on the FDA interactions, but we’re expecting that site to start producing this year and it’s progressing towards that goal. I will mention important to think about — when we talk about RTP, I think because of the proximal nature of when this site is going to come online. Obviously, this is the next large node that’s going to come online in terms of capacity for incretins portfolio. But we are making substantial investments beyond RTP. So, we’ve announced a second site in North Carolina, very large site in Concord, when we’ve announced the expansion of the RTP site additional sites in India €“ or north of Indianapolis and a site in Ireland.
