We have really strong relationships. They’ve put very large team onto this. They’re really going through the data with a fine . They’re asking lots of questions. We’re able to enable them with the specific information, they’re asking about potential next steps. It just leaves us all with a very encouraging set of circumstances that we found a partner that really wants to work together to take advantage of our knowledge of the drug and the disease and their knowledge of the Japanese pharmaceutical landscape, the development and the regulatory consideration. So, I think it’s going well. As we move forward, perhaps we’ll get greater clarity on the timelines, but we’re not in a position to share those right now.
Sujal Shah: And then I know the second question was around top line data expectations. Our expectation is to share both the primary endpoint and the two key secondary endpoints that top line data readout, obviously at that point will have more of an overall safety summary as well. But it is certainly our intention to share alkaline phosphatase normalization, as well as the effect on itch in the patients with moderate to severe itch at baseline, the two key secondary endpoints in the study.
Unidentified Analyst: Got it. Thanks very much.
Operator: And our next question is from the line of Mayank Mamtani with B. Riley. Please proceed with your question.
Unidentified Analyst: Hey, team. This is , asking a couple of questions for Mayank. Thanks for taking them. Just to start-off, but I think this is touched on briefly, but could you give us a little bit more of your thoughts around how you’re thinking about your outcome study both from a design and timeline perspective knowing that we might see a full approval by one of your peers?
Chuck McWherter: Yes. Happy to take that question. Of course, we’re seeking an accelerated approval based upon surrogate that are reasonably likely to predict outcome of Subpart H approval pathway as you know and we have a post approval commitment to document outcomes. We’ve been engaged for quite some time even back in the enhanced study days in thinking through the various approaches that we might use. We’ve had extensive set of interactions with the FDA. We’ve shared study documents. We’ve got their feedback. We’ve adjusted that. We’ve generally gained alignment on what we’ll need to document in terms of conducting a clinical outcome study. We’re not yet ready to share that quite yet for a number of considerations, but we would expect as we get close we’ll be €“ you’ll be learning from us all the specifics around study design, duration, number of patients, what it’s going to look like, how long we think it’s going to take.
Unidentified Analyst: Okay, great. Thank you. And then maybe for Sujal, if you could just talk about how you’re thinking about, I guess, the session planned from the CMO side of things as we get closer to the readout. And as you’re thinking things like post-marketing requirements?
Sujal Shah: Yes, it’s a great question. Look, I think a few important things to point out. With respect to our team internally, we don’t believe we have any gaps as it pertains to executive leadership in the clinical function. Obviously, Chuck, in the end of last year, expanded role from our Chief Scientific Officer to our President of both research and development has really been our internal de facto clinical expert ever since we launched into PBC in 2015. And so, his depth of knowledge and obviously relationship with HCPs across the globe and PBC have really been I think a cornerstone for us, and a foundation for us inside the company. We’ve also assembled, I would tell you, just great execution leads in operations, clinical operations, clinical development, medical affairs, and biometrics.
