Chuck McWherter: Yes. Thank you for that question. It’s a great question. We have a lot of interest terms of understanding the mechanism by the effects. As you’ve mentioned, we did see correlations between baseline pruritus intensity and bile acids, as well as those patients who had a reduction in pruritus. There was also a correlation with reductions in specific bile acids. Our view at the moment is that inflammatory cholestatic disease is connected with both bile acid levels and the impact of inflammation on those. The per se have not specifically been identified, but we’re currently very active in trying to understand what the might be and what the treatment effects, as seladelpar might €“ where the anti-pruritic effects are coming from.
Unidentified Analyst: Great. And just one follow-up. So, on the competitive side, it looks like Intercept is going to be submitting its post-marketing study and real world data to the FDA to fulfill post-marketing requirements. Could you just walk us through any potential implications of a full-approval for Ocaliva? Thanks so much.
Sujal Shah: Yes. I appreciate the question. So, our expectation is the same just based on their public statements. Of course, we know that their committed Phase 4 outcome study cobalt was terminated early. It didn’t show benefit. However, Intercept has obviously generated some data looking at real world evidence. It’s hard for us to really speculate what the regulators will determine. I think one thing, if €“ I think specific to your question, if there is an assessment from regulators around full approval, you know at the basis of that, I would say, is a support for the endpoints themselves, the biomarker of cholestasis, namely alkaline phosphatase, and normalization of bilirubin as being somewhat validated to being tied to improvements and outcomes for patients with PBC.
And so, obviously based on what we see with seladelpar, I think that would be a strong support for what we might also see as we continue to explore the potential of seladelpar to then be tied to improvements in outcomes. These are things that we have to continue to commit to, but I think the essence of your question, if for some reason there was a full approval, I think fundamentally it supports the surrogate endpoint that we’re using in response.
Chuck McWherter: The only thing I would add to that, it’s not really clear what the likelihood of that would be, but if it were to happen, I think there’s no doubt that there’s still a significant unmet need in this population. First of all, patients on obeticholic acid, don’t get to those lower levels of alkaline phosphatase, but about half of the time. And so, you would have to believe that patients getting a benefit and outcome wouldn’t be part of that subpopulation. Obviously, there’s the issues with respect to itch. And then there’s a question of the safety and the visibility of using it in patients with compensated cirrhosis, at least those with evidence of portal hypertension. They’re currently contraindicated in the label. So, there would still be significant needs that need to be addressed and we think that seladelpar would be a potential solution for patients who have those needs.
Operator: And the next question comes from the line of Ed Arce with H.C. Wainwright. Please proceed with your question.
Ed Arce: Great. Thanks for taking my questions and congrats on the recent deal with Kaken. Three for me. First, probably for Lewis. I appreciate all the discussion around your pre-launch infrastructure and your go to market plan. I’m wondering in particular some comments you made about patients in a market research you’ve recently done that show they prefer seladelpar’s profile over Ocaliva. Wondering if you can provide some more commentary there in particular, obviously symptomatic relief? And then secondly, obviously, competitive PPAR compound with Phase 3 data is expected soon. Given the totality of all of the data, especially the recent data, on PPAR that you reviewed in your prepared remarks, how would you view profile overall in terms of the key factors of clinical differentiation, versus that compound?
