We’ll look to execute this study certainly in areas where they may be more limited options for patients. There are already I’d say more limited available treatment alternatives for this patient population to begin with. And I think those are the things that we ultimately anchor on with respect to what is a commitment of ours with regulators.
Cory Jubinville: Got it. In regard to the breakthrough designation expansion for seladelpar, it’d be great to hear more about the data package that was submitted to the FDA to attain that expansion. Was this primarily driven by symptom improvement in response? And, obviously, you’ve done quite a bit of work on IL-31 as a biomarker for pruritus in previous studies. Would love to hear more about what really moved the needle in terms of the FDA’s thoughts there?
Sujal Shah: Yeah. I think I can comment. Our initial breakthrough therapy designation in fact came before we really generated the substantial Phase 2 data set one year as well as a two-year extension data that was recently published in fact and certainly before the subset of data from ENHANCE. And so I think much of the anchoring around the revised breakthrough therapy designation came from the additional data sets looking at effects of seladelpar on pruritus in both our prior Phase 2 long-term extension as well as our prior ENHANCE study. All of these studies in fact also included compensated cirrhotics. So we think that the revision largely came from data sets that continue to mature. And, therefore, again although never guaranteed we’re encouraged by the revised breakthrough therapy designation as it pertains to the indication, the label given the additional data sets only continue to reinforce these potential benefits.
Cory Jubinville: Excellent. Thanks. And last one from us. Can you speak a bit more to the ongoing pre-commercialization efforts for seladelpar? Last year you presented some really great market opportunity data. I would love to hear more about how or if your commercialization assumptions or strategy has changed post RESPONSE? And I guess also on that note thinking about a potential range for the number of sales reps you’re targeting do you have a range that you’re thinking about?
Chuck McWherter: Yeah. Thanks for the question. I think from a pre-commercial perspective I would start really with our medical affairs deployment. I think we’re right on schedule with where we hoped we would be at this stage in time coming out of top line readout and being able to engage KOLs and some of the critical accounts here in the US. And so I think things are progressing very nicely there. I think we begin now to deploy our market access team and begin to really engage payers. We hope to begin that process here in this quarter and moving into early next year really based on [Indiscernible] guidance and being able to really update payers on really the treatment goals for PBC and helping them really understand the opportunity as it relates to supporting these patients.
Our sales force process, we’ve started a lot of the initial analysis here over the last couple of months or so. I would tell you that generally speaking, a sales force somewhere between 50 and 60 representatives is kind of where we would typically see deployment. And I think that generally speaking this is going to allow us to reach somewhere between 5,000 to 7,000 of the gastroenterology and hepatology target audience folks. This is going to get us somewhere around 80% to 85% of the opportunity. So very early on right now in terms of some of that analysis but that’s how we would see some of that at this point.
Cory Jubinville: Excellent. Thanks so much for taking the questions.
Operator: Our next question comes from Eli Merle with UBS. Please go ahead.
Unidentified Analyst: Hi. It’s Sam [ph] on for Eli. Earlier you mentioned that the ex-US filing preparations are in progress. What is your latest thinking around your strategy with ex US commercialization and whether or not you’d seek a partner?
Sujal Shah: I think we’re still in the same place Sam as we’ve been for some period of time. We’ve always had confidence that RESPONSE as a pivotal Phase 3 study would allow us to register seladelpar both in the US as well as potentially in Europe. And so we’re continuing to move forward with a strategy to complete and submit filings ourselves working these in parallel in fact so that we can do so as quickly as possible closest proximity to one another. We’re going to continue at the same time in parallel to evaluate potential interest from licensors that already have infrastructure and capabilities in Europe. I think today the good news for us is with the balance sheet we have we can keep open broader strategic alternatives for the company and not make that decision too quickly.
But I think you’ll see us continue to evaluate each of these opportunities in parallel inclusive of the potential for us to think about a staged commercial launch on our own. So, I think we’re fortunate to be in a position where each of these are alternatives we can continue to evaluate in the near term.
Unidentified Analyst: Okay. Thank you so much.
Operator: Our next question comes from Jay Olson with Oppenheimer & Co. Please go ahead.
Jay Olson: Congrats on the progress and thanks for providing this update. As we look ahead to the liver meeting can you just talk about how you’d like investors to compare the results to the RESPONSE study to the elated results for elafibranor, and maybe compare and contrast those two drugs? And where do you think that will fit into the treatment landscape assuming they both become approved? Thank you.
Sujal Shah: That’s a really good question Jay. It’s a little bit challenging for us to really comment because we’ve seen so little of the top line results for elafibranor out of ELATIVE. I think when we look an anchor around the data that we’ve shared to date from RESPONSE and obviously an expanded data set we’ll look to share a week from today a week from yesterday in fact. I think we are really quite anchored around the fact that seladelpar already appears to be distinguished with respect to normalization rates, which is really where physicians are driving the need to normalize biochemistries in PBC patients and therefore treat a much broader set of PBC patients today that remain at risk of progression. We’re also anchored on the fact that, now response was our second global placebo-controlled study in which we hit statistical significance on reducing itch in patients with PBC.
This is not an insignificant milestone. It’s something that’s been proved to be challenging for other agents and other settings. Clearly, something that PBC patients have not yet had an opportunity to potentially experience with treatment alternatives. This is something that we think is already differentiated from at least the top line data results we heard from the elafibranor ELATIVE study where they did not hit statistical significance on reductions in itch. I think we’ll look more broadly to compare and look at the safety profiles of these two agents as well. There are mechanistic differences between elafibranor and seladelpar. We continue to think that seladelpar is well-positioned to be both anticholestatic and anti-inflammatory. Remember while ALT and transaminases are not part of the primary endpoint for approval this is a chronic inflammatory fibrosing liver disease.
And the impacts we see with seladelpar on ALT and on inflammation we think are also differentiating with existing data sets to date and we’ll continue to look towards the liver meeting at seeing this differentiation as well. So again anti-cholestatic anti-inflammatory and now antipruritic with a safety profile that we believe also well-positions seladelpar.
Operator: Our next question comes from Andy Hsieh with William Blair. Please go ahead.
