Mani Foroohar: And I guess secondarily on the pipeline, obviously a lot of folks are on biliary atresia, given the unmet need there. Presuming that you see a positive result on bilirubin, some perhaps directional benefit on an event rate transplant, obviously there’s a power to that. Can you walk us through what the time horizon would be and what the steps are for you to engage with regulators and then be able to perhaps provide us and investors in a public setting an update on what the filability or path to approvability would be that indication?
Christopher Peetz: Thanks for that question, Mani. The biliary atresia timeline is kind of laying them out in total, expect the top-line data from the EMBARK study by the end of the year. And we’ll then take that data, the way you described, having a positive bilirubin analysis and supportive trends on outcomes would be a really strong outcome here that we’d be excited to take forward to FDA. We’d love to have that meeting in the first half of the year and sometime towards midyear, be able to update publicly on what our plans are on taking it forward based on the FDA input.
Mani Foroohar: Is it reasonable to assume that that might be something we’d hear from you guys like in the first half of next year, or is it just too early to kind of make those assumptions around, like, or how narrow that timeline might be?
Christopher Peetz: We — these types of interactions are dependent on scheduling with FDA. So as we get closer through getting to a meeting with FDA, we’d be able to provide some clarity. For now, the best guidance we have is having an update by midyear next year.
Operator: Your next question comes from the line of Steven Seedhouse of Raymond James.
Steven Seedhouse: I wanted to ask about EMBARK first. Just do you have a sense, based on the demographic you’ve enrolled, of the number of clinical events you’d be able to analyze by the time of the top-line data. And also, the registry work you guys are doing in parallel, will that be available and part of the top-line analysis before year-end? Second, I just wanted to ask about the PBC and PSC data. It’s, I guess, delayed. Maybe you’d refute that, but — and widened in terms of just the expectation on when the timing would be of those interns. Can you just talk about some of the inputs there as well?
Pamela Vig: Yes, thanks for the question. I can answer these. So with regard to your first question on the events for bilirubin, we are seeing events coming in, and as you can expect, these patients with a highly progressive disease. But this is blinded data, and we’ll be able to share top-line more information with you towards the end of the year. With regard to the registry, we’re working very closely with the Natural History Registry, as you alluded to. And what we’re really looking at is aligning our patient population and pulling patients from that registry to really understand, in this particular EMBARK population, what bilirubin levels are really prognostic for transplant-free survival. And that will hopefully, will help to bolster supportive information as part of our discussion with the FDA.
With regard to PSC and PBC, yes, so we’ve seen some screen failures come in since our last earnings call. A lot of these are coming from the e-diary compliance, so patients have to complete a pruritus score daily. So we’re working closely with sites to minimize that. There’s been a few patients that have screened failed for liver labs, screening liver labs, and then a couple for qualifying pruritus scores. But we remain actively screening and really excited to share data next year.
Operator: We now have David Lebowitz of Citi.
David Lebowitz: Considering the EMA recently reaffirmed its decision to not give orphan disease status to Bylvay for ALGS, how do you believe that leads through or does not lead through to the LIVMARLI relative to PFIC?
