And so, we look forward to updating you as we go forward but we’re highly encouraged by what we’re seeing. We’re expected to be able to improve on our clinical experience, we’ve put significant investments in it, and so far we are. Kathie, you want to take the second question?
Kathie Bishop: Yes. With regards to our LILAC-2 study, we just completed that study as we had those patients continue on therapy until the drug was approved, and they had the opportunity to go on commercial therapy; over 90% of those patients did rollover directly onto commercial therapy. We now have those results in hand and we actually plan on presenting them in early December; so in about a month at the American Epilepsy Society meeting. But I will say in LILAC-2 we had very, very few dropouts. So as long as they enrolled in LILAC-2, they stayed in LILAC-2. And I think that’s consistent with what Brendan mentioned is, we think we can sort of get them through that first period, then they continue to stay on to finish [ph] with DAYBUE.
Operator: Thank you. Your next question comes from the line of Tazeen Ahmad with BOA Securities. Please proceed.
Tazeen Ahmad: Hi guys, good afternoon. Thanks for taking my question. Maybe I’ll switch topics for a bit. On the upcoming ADVANCE-2 study, can you just remind us what type of data to expect at that top line readout in 2024? And what would you consider to be good data? Thanks.
Steve Davis: Thanks for the question. Doug, you want to take that?
Doug Williamson: Sure. So the top line data, we expect to see — we’re using the NSA-16 [ph] and the primary outcome is the overall change in the NSA-16 [ph] which is a very well validated and accepted scale for assessing negative symptoms. In terms of what does good data look like, the effect size that we saw at the 34 milligram dose in ADVANCE-1 was around about 0.3 — I think it was 0.34, coincidentally. 0.34 was the effect size; so I think that’s consistent with what generally constitutes a clinically significant change in psychiatric studies. So if we saw that replicated, I think we’d regard that as a good data.
Steve Davis: Operator, next question? Operator, can you hear me?
Operator: Yes, thank you. Our next question comes from the line of [indiscernible] with Mizuho. You may proceed.
Unidentified Analyst: Hey guys, congrats on the good quarter. I guess I’ll switch to drug. On NUPLAZID you mentioned that you’ve benefited from the 340B [ph] program this quarter. Just wondering if this is a one-time thing or do you expect this benefit to process going forward? Thanks.
Steve Davis: Thanks so much for the question. Mark, you want to take that?
Mark Schneyer: Yes. So generally speaking out of the 340B volumes as part of our mix has been slowly growing. I think what you saw in the results this quarter was the artefact of kind of a one-time increase last year that didn’t happen this year; so that provided kind of a net change benefit and revenue when you’re comparing the quarters. I think as we go forward, we’ll continue to expect slow to modest growth in the 340B volumes as we’ve seen over the last couple of years.
Operator: Thank you. Our next question comes from the line of Marc Goodman with Leerink Partners. You may proceed.
Unidentified Analyst: Hi, thanks. This is Madhu [ph] on the line for Marc. A couple of other follow-up questions on DAYBUE from us. First, are you seeing any increases in overall diagnosis rates or numbers of Rett patients who have been identified in the community or when might you start to expect to see that? And then for the side effects, are you hearing anything on whether the side effects are better tolerated in specific patient subgroups like older versus younger patients? Thanks.
Steve Davis: Brendan is the one who takes the first question. Parag, you want to take the second?
Brendan Teehan: Yes. So thanks for the question. Can you forgive me; can you repeat the first question? I apologize.
Steve Davis: The point was, did we see or have we seen any increase in…
Brendan Teehan: Oh yes, forgive me, forgive me. So diagnosis rates; yes, we are — so we’re about two quarters into the launch of the drug. And as we look at data at this point, we’re not seeing meaningful changes in diagnosis rates; I think it’s safe to say that it’s early on. Our first goal is obviously to try and close that gap between the prevalent population, which we know is 6,000 to 9000 and the 4,500 or so diagnosed and treated patients in the U.S. We will continue to track that very closely, we know as a first to market drug is approved, you tend to see increases — you can see increases in the diagnosed population. And I think we’ll continue to share those insights overtime.
Steve Davis: Thanks, Brendan. Parag?
Parag Meswani: Sure. On the second question, what I’ll say at the outset is that we’re very encouraged with the real world experience, both from an efficacy perspective and from an tolerability perspective. Remember, we learned a lot from our Phase 3 program, and that informed the basis of a very comprehensive approach to educating both, providers and caregivers at the outset post-approval. And with the investment received, really favorably, we’ve designed a footprint inclusive of patient support services team that is paired with every single new caregiver, every single new family that goes on DAYBUE, and we supplement that with extensive education to providers as well. So that is — started out launched, it remains a core part of our communication point day-in and day-out with providers and with caregivers.
And because of that, the experience that we’re seeing hearing both, from the prescriber perspective and from a caregiver perspective is that a much better tolerability experience with tools to mitigate any tolerability issues as they arise, whether that’s diarrhoea or other issues as well.
