Kevin Lind: Look, I think from a company perspective, from a philosophical perspective, we would like to get to a broad DEE approval because we think it’s the right thing for patients in the community and the caregivers. We think that it’s tremendously unfair. Rare Disease Day was earlier this week. And we think it’s tremendously unfair that some of these DEEs and these families and these patients with DEEs don’t have access to some of these newer medications. And we think that the current development pathway leave certain people behind unnecessarily. So, from a philosophical perspective, we really would like to do that. And we think that there’s a tremendous market opportunity there well beyond Dravet and Lennox-Gastaut, well beyond what has been seen with Epidiolex or fenfluramine, or some of these other that are more niche.
And so, we would like to get there. From a practical perspective, we want to make sure we do the right thing for this molecule. And we want to do the right thing for our shareholders because the last thing we want to do is create a development path forward that doesn’t work with regulators. That doesn’t help anyone. And so, we are going to continue to work on this messaging and this strategy over time. And I think the most important thing we’re going to see that will impact whether we go down the individual indication route versus the broader basket route is the data from PACIFIC. And so, that’s why we’re so excited about that this year. Because, right now, we can have great conversations with KOLs and patient advocacy groups and walk through why we think this will be so transformative, but until we see that data set, we can’t make that call.
And frankly, it’s all theoretical. So what gives me confidence today is we haven’t seen these molecules work in one indication and fail in another. Remember, Lennox-Gastaut is really a catch all basket. If these molecules were just working in SCN1A patients, then that’s a very, very different thing. We already are starting to see that with some molecules in TSC that are more focused on the tumor side versus the epilepsy side. So for us, we think this molecule has this tremendous opportunity. But what we have to do is make sure it gets to patients. And whether we can get it to the broadest group of patients is our hope and our dream, but we need to see the PACIFIC data.
Operator: Next question comes from the line of Yatin Suneja from Guggenheim Partners.
Yatin Suneja: Kevin, could you expand a little bit more on the dose optimization point that you make? I think it is our understanding that Fintepla was never dose optimized. So I’m just curious to understand from you, what you are seeing on a PK/PD perspective in terms of CNS exposure that gives you confidence that the molecule is better optimized than, let’s say, Fintepla. So that’s first question. The second one is what work you might be doing on the formulation to bring it €“ currently, it’s TID, so maybe do a QD or a B ID, if you can comment on these two questions.
Kevin Lind: Remember, fenfluramine was the weight loss dose arbitrarily cut by some folks in Belgium, great outcome for the molecule, but we really don’t know what’s the optimal safety to efficacy balance with that molecule. Along the way, we saw some dose responses between the low dose and the high dose in a number of their studies, but we didn’t ever really see where the top is. Lorcaserin, whether that drug ever makes it to market or not, we don’t know. But again, that’s the weight loss dose just carried over. And so, for 352, what we’re excited about is the opportunity to really figure out how much receptor engagement do we really want to have, and it’s why we got so excited about the 102 data. So, Randall, do you want to walk through the 102 data for a second?