Dr. Michelle Berrey: Yes. And I think the last thing to note is coming out of the second half of the year as we predicted we’ve seen accelerated growth. We saw this bolus of new writers, demand, et cetera. And we are layering that now, as Jerry noted, with the distribution of our real-world evidence data. And when we test that in market research and have people that are exposed to that data and say, all right. Now project or prescribing, we see a significant increase in allocation of share to Ocaliva, and as we have, and we anticipate additional presentations of new real-world evidence data. AND frankly, the publications that we will be able to disseminate, we see that awareness picking up and really reframing the way that physicians evaluate what does complete PBC management look like.
And they’ve always said that preventing progression, maintaining the patients, those are the important things, and we’ve got not only five years of data from our POISE data on looking at stabilization of fibrosis and bilirubin, but now we have outcomes, and we’re talking about lives, not labs. These are actual patients that are benefiting from treatment with Ocaliva.
Operator: Our next question comes from the line of Thomas Smith with SVB Securities. Your line is open.
Unidentified Analyst: This Mike on for Tom. Can you provide some additional color on where you are with the PBC regulatory discussion, and what, if any, are the remaining gating factors for submission? And then just as a quick follow-up, when in 2023 specifically are you targeting for submission?
Jerry Durso: Michelle, can you take that, please?
Dr. Michelle Berrey: Yes. Thanks for the question. So we have been in discussion with the agency about the content of our planned supplemental NDA which, as we’ve discussed, would include the COBALT results, which we top lined last year as well as an external control. So comparing those patients from — within the COBALT study, who were on OCA to a group of patients from external data bases. We’ve looked at the Komodo database as we’ve released as well as two different patient registries, the U.K. and global PBC databases. So, we’ve been in discussions with the agency about inclusion there. We will also be planning to publish these data as we did with the gastro cover last December in releasing the real-world evidence. The most striking thing about these data sets is the consistency completely independent data sets.
We’re seeing a 50% to 70% reduction in depth and decompensation leading to liver transplant or death. So, we are really excited about those data sets. This would be the first non ultra-rare condition that would include real-world evidence in a significant submission. We know there’s a lot of interest here. That is our plan for the submission. We haven’t yet given guidance on the exact timing of that. As you might understand, with a small group, we are working in two parallel pads, so on the NASH preparations and for the PBC sNDA. So, we’ll give more guidance as that date grows closer. Thanks for the question.
Operator: Thank you. Our next question comes from the line of Brian Abrams with RBC Capital Markets. Your line is now open.
Brian Abrahams: A question on IP. Can you talk about your level of confidence in OCA’s exclusivity extending to 2031, just given all the recent settlements that you’ve been able to do, but still maybe one filer remaining out there. And then how should we be thinking about that expiration potentially applying to OCA in the NASH setting versus just in the PBC setting.
Jerry Durso: Thanks for the question, Brian. Andrew?
