And you can see that’s actually what got the 6- to 17-year-old sNDA that we submitted at the end of last year and the priority review we just talked about during the call. So we have a very robust data set in peds. To your point directly, we’re continuing additional peds studies. We have an additional study gone in 2- to 5-year-olds. That’s part of our working with the agency. And we’re also planning a study in less than 2 year olds, from 6 months to 0, with our partners, AbbVie. We certainly believe with the generation of further clinical data, we have a path in discussions with the agency, to continue to have the label manifest to real clinical profile of LINZESS, which, to date, has been very safe and well tolerated.
Thomas McCourt: And maybe I’ll take the — this is Tom. I’ll take the pediatric opportunity. And obviously, to Mike’s point, we have great confidence in the safety and tolerability of this drug. And the clinical data on the pediatric — out of the pediatric Phase III program is really remarkable. One, it clearly demonstrates efficacy. But what’s been — what striking was how well the drug was tolerated, which is a real challenge with currently available therapeutic options. When I look at the pediatric opportunity, we talk about the 6 million patients that are suffering chronically from functional constipation. But one of the things to keep in mind, which is different from kids, from adults, is the seeking-care behavior. That if you’ve got a kid that’s really suffering, you’re going to go see a doctor.
So the percent of care-seeking patients is a much, much higher percent, and they generally present multiple times a year, not just 1 or 2x. So it’s a very available population. We also know that while there’s a lot of pediatricians out there, it’s a pretty concentrated prescriber base. So we think that we can get to a lot of the top prescribers with our existing selling efforts. So we talk about this concentrated promotional effort because we really want to first understand how promotionally sensitive the drug will be in the marketplace, which will then inform further investment. So we’re not just looking at personal promotion, we’re also looking at other communication channels in which we can educate these physicians on a better choice for managing their patients.
And everything we’ve seen in market research looks very encouraging with regard to the target product profile and the clinical profile of the drug and the willingness to try. As I look at the upside over time, obviously, we hope to get the indication in June. There’s going to — there could be some upside in 2023 as we really evaluate the promotional response. But the real value creation, we believe, will start in ’24 and ’25. But I think we all believe that based on the size of the population, the unmet medical need and the clinical profile of the drug, that LINZESS will be well positioned to help an awful lot of kids.
Operator: Our next question will come from Daniel Wolle with JPMorgan.
Daniel Wolle: Two questions for me. One, on CNP-104. Can you clarify for us what you will see versus what the Street will see when early data reads out in the second half 2023? Is this an internal readout where you announce to opt in assuming positive data on T cell response? Or will you be able to release the data to the Street? And then second question is, if we are going to see some data, will it just be on T cell response? Or is there potential to include changes in serum outcome and phosphatase levels? I guess, my question is, is it possible to see serum outcome, phosphatase level changes data this year?
