Manmeet Soni: Sure. Sure, Charles. This is Manmeet. And as I said earlier, we continue to work on competing the manufacturing of maps, commercial drug supply and anticipation of the launch. To answer your question, we have a couple of CDMOs, like a couple of contract manufacturers who we are working with to do that. And we have been working very closely with all of them, and we believe they are very well prepared for the FDA PI inspection of the drug product and the API manufacturing sites. And the companies or the CDMOs, which we are working with are very well known, who regularly receive FDA PI inspection, and we work with them on a continual basis. So that’s what I could add. Does that answer your question?
Charles Duncan: Yes, it does. Can I ask a question about European commercialization? I guess my quick question is what are you thinking about in terms of strategy there, would you seek a partner? Or do you think that you can execute well going on?
Manmeet Soni: Yes. As you recall, in end of 2019, we acquired the European rights from AbbVie and our intention and strategy has been since then to go and launch in Europe directly over there. Obviously, we’ll assess all — everything will be on the table. But right now, we are planning to launch directly. We have hired our leadership team, including marketing, payers, medical affairs, all have been established very recently, and we continue to enhance the infrastructure over there in the next coming quarters as we plan to file a date of this…
Operator: Our next question comes from Carter Gould from Barclays.
Carter Gould: Thank you. To maybe change it up a little bit. As you think about — I don’t know if there are any lessons you guys have incorporated as you think about other recent neuro launches and go-to-market strategies and some of the pushback they receive, maybe just kind of the best practice as well as you think about potential commercialization early next year? And then separately, just as we think about bardoxolone, obviously, you’re going to have the Japanese study is going to read out early next year. Is there a chance to engage with FDA simply based on that data versus also having to wait for Falcon just given sort of the pace time line to enrollment there.
Dawn Bir: Carter, this is Dawn Bir. I’ll take your first question. So as we think about commercialization early next year, we’ve been preparing internally for quite some time and putting a lot of effort in to understand the market, the patient community. And so as I consider other rare disease launches, this is really critically important to gain support of the community well beforehand. And so Reata has been quite engaged on this front for quite some time. We’ve also scaled the organization very appropriately and carefully and we believe that we’ve got the right headcount in place and we continue to grow with the regulatory progress that we make. And so we’ve done a bit of work now to understand the target market audience who are the treaters of FA, and we know who they are and where patients are in the United States, and we’ll be focusing our initial commercial efforts in that particular area.
So with rare diseases, it’s quite complex because some types of patients go undiagnosed until there’s a therapy available. So we’re very fortunate that with FA, we believe that most of that patient population has been diagnosed and it really helps guide our efforts. And so, in terms of commercialization and contrasting to other launches, I can really look at the preparation that we’ve taken and really highlight the fact that we’ve been very aligned with the communities that are necessary. So I hope that answers your question.
Carter Gould: Yes.
