We of course, would have to have an end of Phase II meeting with the FDA, have them agree on our Phase III plan and move ahead. But we’re doing everything that we can currently to not only recruit these investigators and that actually got to start at the IMPE meeting this weekend in Buenos Aires. But I have everything that we can possibly do in advance, completed in order to start as quickly as we can, where we haven’t taken guidance beyond that.
Eun Yang: I see. So when do you think you’re going to be in a position to have a Phase II meeting — with the end of a Phase II meeting with the FDA. Is the first quarter next year be reasonable?
Richard Hawkins: John, I’m going to let you answer that question.
John McKew: Again, we haven’t guided on that publicly. But obviously, we have to get through the data sorted out, put in a package and wait for the FDA to grant and schedule that meeting. So I think there are a lot of factors that lay in there. But we haven’t projected that out yet to the public.
Operator: Our next question comes from the line of Ed White with H.C. Wainwright.
Ed White: So just saying on the potential Phase III, I know that you’re — you don’t really know much about it right now, what you’re going to do, but I’m just wondering if you could tell us what you’re expecting for perhaps the duration of the study? Will this be following the patients for 1 year? Will it be 6 months? How are you thinking about that? And also, I assume that you’re budgeting out for this, so just any cost expectations regarding perhaps the size of the trial? And also, the last question will be, since you lost Russia and Ukraine, where do you expect to enroll the most of the patients?
Richard Hawkins: Maybe I’ll start, and then David, if you’ll chime in here. So we projected — I mean the regulatory pathway for growth hormone and growth hormone products is really clear. We think we’re going to be is this will be approximately 160 to 200 patients, same patient population we’ve been studying in our current study, but we’ll randomize 2:1 to 1.6 versus the standard dose of growth hormone. All patients will be on drug for a year. We really haven’t talked about our budget for that study to date. So I can’t really give you any guidance on that. But I think I answered your question maybe a little bit earlier, Ed, and that is the loss of the Russian and Ukraine sites, yes, that makes a difference. But there’s a whole new set of investigators that all of us know who have been in this field for a long time, who have been prolific Phase III investigators, actually, many of whom don’t even participate in Phase II studies.
And we’re going to meet — we’ve met with those folks. We will meet with them at IMPE, this coming week, and we’ll continue to talk to them and bring them on board. So most of those sites are in the U.S., but there are other sites around the world that are prolific investigators in Phase III programs.
David Karpf: And if I could just add, I would say that I’ve been very pleased to see that the Polish investigators have enrolled more than the Russian Ukrainian investigator did in the high program. So that’s kind of a wash there. But also, I enrolled 164 subjects in the high trial in 12 months. And that was without the benefit that we’ll be having of having high-enrolling sites in like China, which have been really tremendously rapid enrolling growth hormone deficiency trials. So I think that having high-enrolling sites in the U.S., including, as Rick mentioned, some really key high enrollers who only participate in Phase III and having similar folks in U.S., in Poland, in Europe, in Australia, in New Zealand, China, Japan and Korea, I think that we are very bullish on the enrollment for the Phase III trial.
