Linda Richardson: Yes, we cover right now from our analysis. Three out of four of the top potential NASH potential prescribers already exist within our PBC call list. So we’re bringing in new PBC prescribers but also have established relationships over the past six years as you know already with Ocaliva in that same target audience. So we feel comfortable that the work we’re — the ground work that we led with PBC will translate very efficiently into a NASH, potential NASH launch.
Mayank Mamtani: Got it. And my final question on the FXR PPAR combination Phase 1/2 data that you intend to report later in the year. Could you just maybe provide some thoughts on what Phase 3 design you might be thinking since you are in a unique position to pursue two currently approved therapies in this drug class. So just I know it’s early, but it would be great to hear your thoughts on the Phase 3 deal?
Jerry Durso: Michelle, do you want to take that one, please?
Dr. Michelle Berrey: Sure. Yes. Great question. We are really excited about the fixes combination of OCA plus bezafibrate. And as you state is we are in a unique position to have two potential therapies in PBC. I hesitate to give much detail on our plans for the Phase 3 until we have those conversations with the FDA to review all the very exciting data coming out of the Phase 2. But we feel we have the potential here with the combination for potential best-in-class for PBC. So again, it really underscores our long-term commitment to innovation in this space.
Operator: Our next question comes from the line of Yasmeen Rahimi with Piper Sandler. Your line is now open.
Unidentified Analyst: This is Emma on for Yas. My question is what are your thoughts on the recent ICER pricing report? And with that, are you still thinking about differential pricing in NASH versus PBC? And what type of payer discussions have you had to support that, if any?
Jerry Durso: Thanks, Emma. Maybe I’ll give some overall view on how we’re thinking about pricing and then Linda can comment on ICER. So as you would imagine, we’re doing all the right work as we prepare for a launch that includes some up-to-date dialogue with our key payers, and those are ongoing will of course take a pricing decision once we have the full information, including final label. But we continue to work towards all the right steps to have optionality on pricing between Ocaliva and OCA and NASH should we choose to execute a pricing strategy that way. So, we would anticipate a separate brand, separate NDC, the things that give us that option. And all the updated work, including those discussions with payers are going to be important inputs.
We’ll share more thinking about our strategy with the with the payer, which will, of course, be foundational for the launch as we get closer to the PDUFA date. And again, I think it’s been several years. We’ve had dialogue with the payers going back to before the first PDUFA date. So we’ve done a lot of in-depth work. We’re revising it with the current context as you would need to and then perhaps Linda, can comment on ICE.
Linda Richardson: Yes, of course. Thanks for the question. Frankly, we disagree with several of the approaches that were used within the model, which generated the draft evidence report, specifically, when we look at the model, it does not define a standard that constitutes an acceptable data set and implies. It kind of applies an inconsistent approach and the exclusion of available data for different therapies. So what do I mean by that? An example is, it includes only Phase 3 data for OCA but put both Phase 3 and Phase 2 data in for Madrigal. And even though the Phase 2 data did not include fibrosis improvement without worsening of NASH, as a primary endpoint, and then furthermore, it does not use the updated available information for OCA.
