Robyn Karnauskas: Okay, great. Thank you.
Operator: Thank you. Our next questions come from the line of Yatin Suneja with Guggenheim. Please proceed with your questions.
Unidentified Analyst: Hi. Good morning. This is [Delma] (ph) for Yatin. Thanks for the update. Could you please clarify what are the safety long-term requirements for submission for the TRANQUILITY program? And then, in the next TRANQUILITY study, are you planning to use that clinical site which — where you saw misconduct issues? Thank you.
Vimal Mehta: Regarding the long-term safety, as we have outlined, that is a — will continue to be a topic of discussion with the FDA. Our drug is acute treatment of agitation. It’s episodic in nature. Depending on what is acute and episodic and what is chronic, those discussions will continue. So, it’s a topic that we — based on our frequency of agitation, we will discuss with the agency. In terms of the site, we are not planning to use that site which you mentioned, and that was specifically a site designed for an ALF setting. And now, as we mentioned that we are moving forward with the at-home setting, so we’ll be using the new site.
Unidentified Analyst: That’s helpful. Thank you, Vimal.
Operator: Thank you. Our next questions come from the line of Graig Suvannavejh with Mizuho. Please proceed with your questions.
Graig Suvannavejh: Thanks for taking my questions. A couple, if I could. Just with respect to the comments around long-term safety requirements, I’m just wondering in support of an sNDA in the 80 agitation setting, what is your current expectation around what you’ll need? And I guess the question is beyond the 100 patient four-week study, is there a current thinking that you will need additional long-term safety in order to support an sNDA? And then, a follow-up question, if I could. Just on the current OpEx, I think it came in significantly higher than we were expecting. And given the current burn, I’m just wondering how we should anticipate OpEx to evolve in the fourth quarter and the first half of next year. Thanks.
Vimal Mehta: So, Graig, regarding the long-term safety, as I mentioned, this will be a continued topic of discussion. It will happen between now when we are initiating the home-setting trial as well as at the pre-NDA meeting. There is not a like — there’s not a drug that has been approved which is acute treatment for agitation in Alzheimer’s and is episodic in nature. So that package will be discussed with the agency and we will continue to update like where we are on those discussions. Currently, we are focused on the study for the at-home setting pivotal trial that we have agreed with the agency. In terms of the cash burn rates, I will pass it on to Richard to provide color on it, what our guidance is.
Richard Steinhart: Sure. So, good morning, Graig. How are you? The results of the reprioritization will begin to impact the fourth quarter and then certainly into next year. So, we’ll see our burn rates start to decrease. In addition, there were a couple of one-time charges in this quarter that won’t be repeated moving forward. So, overall, we expect the burn rate to decrease next quarter and then continue into next year.
Graig Suvannavejh: All right, great. And if I could ask maybe just one follow-on. The J-Code, how should we expect how that might impact the trajectory of, like, sales? Thanks.
Richard Steinhart: So, Graig, first of all, we were very pleased with CMS’s decision to issue a permanent J-Code. We do believe that this will neutralize any economic concerns that hospitals and clinics might have in putting IGALMI either on formulary or providing broader use within the hospital or clinic. So, we look at this as a positive. Certainly, our corporate account director team has been getting positive feedback from either key hospitals or systems that they’ve been in contact with. So, we feel very good about this development and do think that it alleviates one of the barriers to increased use.
Graig Suvannavejh: Thank you.
Operator: Thank you. Our next questions come from the line of Corinne Jenkins with Goldman Sachs. Please proceed with your questions.
Corinne Jenkins: Great. Thanks. I guess a couple from us. When do you anticipate that you’re going to be able to finalize these protocols and initiate the at-home study for TRANQUILITY? And based on one of your prior answers, will these all be new trial sites that you need to enroll at? And then, on the TRANQUILITY point, you guided I think for 100 patients in that study, but it sounds like you’ve yet to determine the primary endpoint that you’ll be evaluating. So, how did you come up with that guidance for the number of patients required? And could it evolve as you determine the protocol?
Vimal Mehta: So, in terms of the protocol, it’s under development. We had a meeting with the FDA last month. So, we were expecting the meeting minutes to confirm our understanding. But protocol is in progress. We are finalizing the protocol once we had input from all our experts or at board then we will submit the protocol to the FDA. And after protocol has been submitted, as you know, we will be in a position within a short time after that to be able to initiate the trial. So, I will and we will provide the guidance on when we think the trial can be initiated and when first patient will be dose. Also, we are in the process of finding how many trial sites we will open and what the recruitment rate will look like. Coming back to your question about the 100 number, that was — as you saw, that — it is designed for safety and to collect efficacy data.
So, FDA and us felt that that number will be sufficient to add to our current data set we have with 501 in the elderly patient population. So, those were the choices and decisions we ended up making what needs to be shown in a home setting, what patient number will be relevant, and what the success criteria will be in terms of demonstrating the safety profile. Rob, you like to add anything?
Rob Risinger: Just that the protocol in development is really focused on both feasible and rapid generation. And I recognize this is a pivotal trial, but the primary aim is described safety in only about 100 patients and they are being treated as needed with the 60-microgram dose or placebo. So, it’s designed to generate placebo-controlled safety data on adverse events for the FDA to review with respect to including these in a potential labeling at home. So, we’re not able to say when the results will be available. However, we’ll share more facts once the protocol is finalized, and of course, we expect that we’ll announce when the enrollment begins.
