And they — most of them acknowledge that we have a couple of kids who are growing outside of that range. So I think the key thing really is just to focus on the efficacy of the drug because as you said, Phase II is not powered to show noninferiority anyway. And so I think focusing on the efficacy of the drug and moving forward with that as we plan Phase III is kind of the key part that we’d like to spend our time on.
Richard Hawkins: David, do you have anything to add?
David Karpf: Sure. I would just add that to our experts, clinical pediatric endocrinologists, their expectation in this population is not to be with growth hormone. It’s actually much lower than that, which is why I think they were so encouraged by our results. I share the view having run the high trials with Skytrofa, I mean, should be barely above 10 centimeters in a more severe population in that trial. So I really expect that growth hormone in this population in Phase III will be below 10 centimeters. Just as a point.
John McKew: Yes. And just one other point is that in a true Phase III noninferiority trial, the last 2 companies to negotiate that difference with the FDA’s 1.8 to 2 centimeters. And obviously, we get a product approved, and we’re as an oral once a day, I think that there will be a significant and meaningful place as a treatment in the market as the first oral product.
Catherine Novack: Got it. That kind of leads into my second question. You may have answered it a little bit. But I want to talk about how important compliance is when it comes to efficacy in daily recombinant growth hormone. When we look at the — what you’ve cited from the GeNeSIS database, for example, we see AHV that’s significantly below control arms in recent Phase III studies for growth hormone. So does this due to higher compliance or to this age more severe growth hormone deficiency that are contributing to that difference.
David Karpf: If I could…
Richard Hawkins: Yes. Go ahead, David, do you want to start?
David Karpf: Yes, sure. The GeNeSIS database and the KIGS database that we referenced for this, first of all, compliance in the first year of treatment is actually pretty good. And we’re looking at the first 12 months of response in those large databases. So I think that the lower AHV is more because of the population, either PEM-positive in the GeNeSIS database or the less severe in the KIGS database, which more closely matches the population we’ll be studying than it has anything to do with compliance, quite honestly.
Richard Hawkins: Okay. And John, anything else you had to want to add ?
John McKew: No, that’s fine. I agree.
Operator: Our next question comes from the line of Eun Yang with Jefferies.
Eun Yang: So assuming good data in the fourth quarter this year, when you — if you embark on a Phase III trial sometime next year, how do you see enrollment taking — how long do you think enrollment would take? When do you think that you would be in a position to actually report the data?
Richard Hawkins: No, we have — let me start, David, please. So first of all, I mean, we’re really pleased with the enrollment in this trial. In spite of these really difficult times during the pandemic and losing all of our sites in Russia and Ukraine. In spite of that, we’ve done really well. And I tell you that these investigators are all experienced. They’ve all done many clinical trials, and we certainly have their attention because this is the first oral product they’ve worked with in their careers. I think there’s another set of investigators that we know about who only participate in Phase III studies, and they are high enrollers. So I think we’ll do well with that. Now we haven’t really guided the market in terms of when we’re going to actually start the Phase III study.
