Charlie Robb: Yes. Hi. I guess I’ll start taken into two parts, obviously. Because our IP protections for Korlym and or rather Korlym, I’m really sure they’re completely separate. As far as the developments go, with respect to Korlym, as I mentioned, we had the trial at the end of September. And I really want to stress that there, the patents we are defending, we are asserting against Teva, really concern the co administration of Korlym with a really broadly prescribed class of drugs that are important drugs for everyone but also are commonly prescribed to patients with Cushing’s syndrome. So, the trial, I think went very well. I think we’ve made exactly the case we needed to make. And so, in terms of commentary on our Korlym IP, I feel very good about it.
I think we brought it out into court, it performed very well, and, I’m confident that it’s now enhanced to judge. That IP runs through 2037. So those two patents, and there will or maybe further patents that come out of our work in the coming months years with respect to Korlym, but right now, we’re protected through 2037. Now, relacorilant is as you know a novel proprietary compound unlike Korlym, which is the active ingredient, it’s a generic compound. And so, with respect to relacorilant, we have patents on its composition of matter, we have patents for a variety of uses for the compound and for its sister compounds in a range of disorders, including the ones that we’re studying now. And that protection runs past 2040. So, we have I think extremely robust sort of multilayered sort of IP surrounding relacorilant and there will be more being developed as our investigations continue to make new inventions that are worthy of patent.
So, I hope that answers your question.
Roanna Ruiz: That helps. And then second one I had, just tagging on about the GRACE trial reading out soon. I was just curious if you could explain what the statistical powering is for the endpoint there and anything else we should think about in the data?
Joseph Belanoff : Sure. I’ll answer that question. So, this disc overpowering is to look at the loss of response. We have 90% power to detect a loss of response of about a 50% difference between staying on relacorilant and maintaining that response or switching to placebo and losing their response.
Operator: Our next question comes from Joon Lee with Truist. Your line is open.
Joon Lee: I have a question on timing of the NDA submission in the second quarter of next year. Would you want to wait for the gradient study by mid-year to submit more fuller picture of the drug? What’s the rush there? And would the FDA want to see it? And the other question is one of the drivers of called and franchise that keeps surprising you to the upside.
Joseph Belanoff: Okay. Two different questions. Let me, Joon, give you first to Charlie for the NDA question.
Charlie Robb: So, yes, we’re the — we think that the most important demonstrator of in Grace’s safety and efficacy of relacorilant safety and efficacy in Cushing syndrome will be the GRACE trial. We think that’s sufficient to support our NDA. And so, we’re going to go with that, because it will be ready, and ready first, ready to proceed and just continue to move our business forward as expeditiously as possible. We will be in a position just procedurally to submitting know additional data to the FDA as gradient comes in, if that’s important to pressing the NDA forward. So, I think we retain some real optionality there without having to sacrifice the pace of our timelines.
Joseph Belanoff : And Joon, second question, would you please repeat that?
Joon Lee : Yes. So, what are the drivers of Korlym franchise that keep surprising you to the upside? You upgraded guidance, I think two quarters in a row, not if I’m not mistaken. So just curious what’s the driver of that?
Joseph Belanoff : Good. No, I understand the question. I’m going to pass you back to Sean.
