Charles Duncan: I had a couple of questions on 352. I’m just wondering if you could provide us a little bit more color on the types of patients that are really joining into this study. Can you tell us whether or not they skewed to the younger ages? And I note that exclusion criteria includes the use of fenfluramine. Is that forever in a Dravet patient completely naive or could some of those people have been exposed to fenfluramine in the past?
Randall Kaye: We have opened up the study originally starting as an adult population, 18 and above, and then dropped the population as additional confirmatory preclinical safety data emerged. So we felt comfortable moving into the adolescent population down to 12. We are seeing patients coming into the study within the adolescent population. We haven’t put specific numbers out. So it’d be hard to answer your question about skewing towards, but we’re satisfied that we’re getting a nice balance of patients. Your second question, let me clarify. We exclude patients who have failed conforming. Failure would mean they had no discernible treatment response to fenfluramine or they had an adverse event profile or a side effect profile that would preclude its use. So, if a patient, let’s say, had been on fenfluramine, but insurance wasn’t covering it, or the parents didn’t like the inconvenience of regular echos, that would be a subject that would potentially be included.
Charles Duncan: In terms of the actual conduct of the study, are you allowing down titration during the maintenance phase? Or is that just not necessary? Are you not seeing any of that over the course of the study so far?
Randall Kaye: It’s an interesting question. So the way the protocol is written, we use the up-titration portion to get them on a dose that they’re tolerating. So start at 6, go up to 9, go up to 12. But we’re going up by tolerability. We’re not forcing and pushing everyone up to 12. So the expectation is, when they get into the maintenance period, they’re tolerating 352 well. Our expectation is that they will stay on that dose for that time period. Would we theoretically allow some flexibility? I guess we could protect potentially, but generally, the approaches that we’ll have them on the right dose that they can tolerate and stay on that during the maintenance period.
Charles Duncan: Last question quickly is, if you considered success, I think the first analyst asked a question about seizure reduction frequency. Is anything beyond just simple seizure reduction that you would be looking at from an efficacy standpoint that you’d be intrigued with, being able to show, particularly given the safety profile of the drug, and seeing, I guess, compliance or dose density over time? What would intrigue you?
Randall Kaye: I think it’s important to frame this as a safety and tolerability study and also proof of concept that you can treat a heterogeneous group of patients across the DEE spectrum. So success would be safe, well tolerated, and some comparable seizure reduction. I’d love to start to talk about some of the other potential areas that you can start to look at in larger studies, such as quality of life, clinical global improvement, and so forth. But that’s just going to have to wait until we move into pivotal studies next year.
Operator: Our next question comes from the line of Laura Chico from Wedbush.
Laura Chico: I’ve got two more strategic questions for you, I guess. The first one, assuming success with PACIFIC, I’m wondering how we should be thinking about the potential or the feasibility of using a basket registrational study, kind of expanding on the PACIFIC design, if you would. Secondarily, Kevin, maybe from a strategic perspective, wondering if you could take a step back for us and comment on what gives you confidence in the market opportunity within the DEE space specifically.