Joshua Schafer: Thank you, Sumant. Maybe I’ll take that one. We get as part of the NDA resubmission information requests from the agency, which we’ve been to satisfy and return in a timely way. One of those requests, as we’ve announced previously, was a satisfied the requirement of becoming a major amendment, which then caused the delay of 3 months and our September 21 PDUFA. So we are having those discussions, information requests are coming in and we’re able to satisfy information requests in a timely fashion.
Sumant Kulkarni: Got it. And then on the recent Phase II data in IH, we’re yet to see any quantitative details because of the sleeping related embargo. But qualitatively, would you say there was anything counterintuitive either in a positive or negative way in the data relative to your original expectations?
Neil McFarlane: I think the most important lesson from this was on the primary endpoint. So we dose basis at 20 milligrams, which is a pretty high dose, high than dose in patients. And we saw no increase in the safety profile and safety. More importantly, the cardiovascular safety profile is exactly as we had expected and there’s no changes in the cardiac safety profile. So have a compound that electrical safety and then to patients with liberate insomnia.
Operator: We’ll take our next question from Louise Chen with Cantor Fitzgerald.
Louise Chen: First question on KP1077. Post results, I wanted to close competitors in IH. What differentiates KP1077? Our second question is on arimoclomol. So where pediatric this year. The much more get approved and a program becomes terminated, you how might impact the value of arimoclomol PRB.
Joshua Schafer: You were challenging to hear. I understood the question to be if we were going to get a PRV with approval of arimoclomol. Is that correct? And then the other 1077 program in regards to the differentiation from competitors?
Louise Chen: Yes. That’s correct.
Joshua Schafer: Okay. So yes, we have a PRV that will be issued upon approval with our arimoclomol’s NDA approval. So that does.
Neil McFarlane: I would add, Neil, that — and in part, I think what you said is what is the likelihood or what do we think the value change is the program governing that would be ending this year. And I think the analysis we’ve seen or information we’ve heard from a variety of sources as a potential if that program ends, the value could go up. So I think we’re going to assess that and look at that, but that’s our current thinking on that point.
Adrian Quartel: Adrian here. In regards to the competition in the space. So a differentiated profile, — different pharmacokinetic profile in the market and also a specific mode action being stimulant. There’s only scheduled 4 program. And as I said previously, the cardiovascular safety jumps out when you look at the benefit of this program compared to go on the market.
Operator: [Operator Instructions] We will take our next question from Tim Lugo with William Blair.
Unidentified Analyst: This is Lachlan on for Ken. I guess first 1 is just on the oral it sounds like obviously lower awareness maybe don’t have a ton of experience. But can you maybe talk about the feedback that you’ve got thusfar I know you do have experience? And then second, I understand meant to lose exclusivity at some point in the next year or 2. So can you just sort of talk about your expectations for that and what it might mean for the market and for all maybe what sort of scenario is there?
Neil McFarlane: Sure. Thanks for the question. Yes. So has been more for the reasons that I stated. And our primary objective now is to really build that awareness, working with physicians to identify those appropriate patients and to put in place programs so that patients can gain that experience with OLPRUVA. The initial feedback that we’re getting is those patients who have had experience with OLPRUVA are continuing on that. We have a number of patients who are continuing to get refills of OLPRUVA and that really bodes well for future uptake. In terms of RAVICI and the patent exploration are, I guess, it’s really the entrance of authorized generics. We are aware that later next year, it’s likely that an authorized generic come into the market and potentially a second thereafter.
We view that really as entrance into the higher end of the market, specifically a product team with the same formulation. OLPRUVA is very much slightly differentiated from and in the off-price generic that comes into the market. And we believe that we’ve got a great and were well priced to be able to compete in this market.
Operator: And next, we have a follow-up question from Oren Livnat with H.C. Wainwright.
Oren Livnat: Just to follow-up again on OLPRUVA. I know it’s quite early, but as you get more patients hopefully into the funnel, to the referral network and then as you try to get them through adjudication to paid therapy. Are you finding that you’re being held to the hurdle of compared to a generic from a cost perspective? Or is the bar more likely lower and that you’re essentially being benchmarked against market-leading. And regarding the patients you’re going after, are you assuming current RAVICTI patients are low hanging fruit given you’ve got a presumably much superior product here from the patient perspective conversely, are they maybe the stable business and your target?
