Chaim Lebovits: So, we have to start of the bit and I would like to bring in our Chief Operating Officer, he’s working on this over a year now. We are preparing for success. As you can imagine, David, you want to answer this question?
David Setboun: Sure. So, thank you for the question. We obviously been working on it for quite some time. We have as well, the market access and pricing capability and expertise in-house, so we’ve been engaged with payers for quite some time now.
David Bautz: Okay. And I guess, kind of, as a follow-up, without holding you to any hard and fast numbers here. But how quickly would NurOwn be available say if it was approved? And then where does your manufacturing capability stand at this point for how many patients you could treat say in the first year or so?
David Setboun: Yes, that’s a wonderful question. Of course, we’re not going to go into hard numbers, but I will generally tell you that we have an outstanding partner with Catalent. And the Princeton site is very dedicated to us. And we have additional sites here in Israel as well, so we will be able to treat patients immediately after approval. And of course, we’ll have to enrol those patients, et cetera. But from the manufacturing capabilities, we technically are able to treat now patients if they — if we were to have an approval, so thank you for that question.
David Bautz: Okay. And thanks for taking the questions.
Chaim Lebovits: Sure.
Operator: Your next question for today is coming from (ph), a Private Investor.
Unidentified Analyst: Yes. Good morning. As you know, my son Matt was in Phase 3 and received six doses in Expanded Access.
Chaim Lebovits: What was your name? Sorry, I don’t need to interrupt. Yes.
Unidentified Analyst: You are breaking up.
Chaim Lebovits: Sorry, yes. I didn’t hear the name.
Unidentified Analyst: My name is Myrrh Klingenberg.
Chaim Lebovits: Okay. Thank you.
Unidentified Analyst: You bet. So, I was wondering if you were — my son Matt was in Phase 3 and in Expanded Access. We are very pleased and thank you so much. So mass symptoms started over five years ago, and he’s still walking, talking, eating, breathing, all of that. He has not been (ph). So, I was wondering, is there any information about people in Expanded Access during the trial and whether or not they’re trached and how long they live? And are you planning on releasing any more information about this study like you have through manuscripts and presentations prior to the ADCOM.
Chaim Lebovits: Thank you very much. That’s a very good question. We did speak about it before, but I will let Stacy follow-up and give you more specifics. Thank you for the question.
Stacy Lindborg: Yes, thank you very much for the question and we’re really pleased to hear your son is still doing so well five years into the disease, so it’s quite remarkable. From the Expanded Access program. Well, first in terms of trachs, we did not have any trachs during the Phase 3 trial. We just brought the data in-house and I actually haven’t seen yet the rate of any trachs that were given during the expanded access programs, I won’t comment there. But this data becomes important to ongoing learning and it will be something that we will want to present in not only scientific forums, but also understand the body of evidence and how it relates to the approval of our product. So, we’re working internally to analyse the data and then we’ll proceed with discussions with regulators, as well as sharing data in the public domain.
