So the question is, when you treat adult patients who have more mature disease or more progressive disease over the age of 18, will it take much longer for any product to have impact versus once you drop the age, could you have much greater clinical efficacy impact. So our hope, even though the initial dataset that we’ll accumulate over time will be safety data. The big question on the table is will we also show greater clinical efficacy impact? And my hope as a clinician is that is what we will also see, which will allow us to show the strength of our gene therapy intervention for Rett syndrome, which as you know, is a terrible disease by treating the root cause of the disease. So that is our hope, and I hope that answers your question.
Yun Zhong: Okay. Great. Thank you.
Operator: Our next question is from David Hoang with SMBC. Please proceed with your question.
David Hoang: Thanks for the update and taking my question. I had one question just with GAN. Have you consider €“ are you formally considering accelerated approval pathway there? Is that something given the endpoints and the data that you are now reviewing? Do you think that path would be available to pursue? And if so why or if not, why not?
Sean Nolan: Suku, would you please take that question?
Sukumar Nagendran: Yes, Sean. I can only give you my opinion based on the data that I’ve seen in our overall regulatory discussions, right. So obviously, what we can do is look at our dataset, see if the broad impact of our product gene therapy is truly clinically meaningful, and then ask for the meeting with the FDA. And absolutely, if we believe our product is truly making a difference in this ultra-rare disease, while there’s no treatment option available, I would absolutely love to ask for the FDA to consider our product for accelerated approval such that we can make the medicine available to patients. But the caveat is this, right. So this I have to be very clear on is we have to have a collective dataset that truly enables us to make a convincing case with the FDA that this gene therapy qualifies for accelerated approval.
So that is what we are hoping for, and that is the plan when we submit our request for an FDA review once we do complete our full analysis, okay. So I hope that helps, and I don’t know Sean, if you wish to add anything more to what I said?
Sean Nolan: Yes. Look, the only thing I would add to that is when you think about some of the remarks from what Dr. Peter Mark said has said multiple times publicly, and you think about the disease state of GAN and a product that could merit an accelerated rule. It certainly fits the bill. We don’t want to get ahead of ourselves at all, and we don’t want to prejudge final data. I would just say that based on the preliminary assessment, we’re encouraged about the package that we can put together and we will certainly make the most aggressive presentation we can based on data to four patients, and to get down this product as soon as possible, given that there’s nothing available to particular point in time. So if we’re convinced the data is compelling and meets the bar, you would push hard for something like that. Thanks for the question.
Operator: Thank you. Our next question is from Joon Lee with Truist Securities. Please proceed with your question.
Joon Lee: Hi. Thanks for the update. When you say in your press release that the FDA is open to regulatory flexibility in a €œcontrolled trial settings€, does that necessarily refer to placebo controlled trial setting or can that include some other controlled setting? And it’s the latter, what could it be?
