Unidentified Analyst: Hi. This is Rohit on for Gil. Thanks for taking our questions. Can you just talk about the ex-U.S. market for TSHA-102, and would you be open to partnering the program? Thanks.
Sean Nolan: Well, I would say that the opportunity is significant, right? I think when we talk about the factors, there’s approximately 25,000 patients in the U.S. and EU combined. So the opportunity over there is significant. There’s good infrastructure over there in terms of clinical study sites, treatment centers, the patients are well identified. So we’re encouraged by the opportunity over there. It’s one of the reasons we’ve focused our clinical efforts in submitting that CTA mid-year into the UK. Just trying to think of the second part of the question. Well, the partnering aspect, I would say that that’s something that we would potentially consider. I think you always have to look at all options, your current capital situation and make a determination on resource wise and otherwise, is it better to partner that or to better to keep it to yourself.
Right now, the plans are for us and we have the funding this year to execute the trial as we’ve outlined it, the plan trial, I should say. So it’s an option that we have, should we decide to pursue that.
Unidentified Analyst: Thank you.
Operator: Thank you. Our next question is from Silvan Tuerkcan with JMP Securities. Please proceed with your question.
Silvan Tuerkcan: Yes. Thank you. Thanks for taking my questions. Just to come back to GAN, I think the last time the FDA attempted you a modest or I don’t remember exactly the wording, effect on the primary endpoint and that’s why they wanted maybe a controlled trial. But I mean, obviously those are just words. And so how do we know now that they’re open to a strong efficacy measure that you have met the bar with these additional endpoints. Could you stack them together to show a strong outcome here with the data at hand or how do you imagine this will play out? Thank you.
Sean Nolan: Well, I would say first of all that what the FDA said at the meeting minutes, the initial meeting minutes was very focused on MFM32 because that’s where the majority of the discussion happened. That was the primary endpoint, that was the focus of the company. And so all of their comments were generally around that particular endpoint where they basically said, because they believe it’s subjective, you need to have a double blind randomized controlled trial. So when we went back to them and we asked the subsequent questions, I would say that the new news is that they restated their review on MFM32, but then they said that they’re willing to evaluate alternative trial designs that are controlled and a control can be natural history as you know, that have endpoints that are clinically meaningful and essentially objective.
And so that is a, I would call it a door that was €“ a new door open there opportunity wise that makes a lot of sense to us so that it’s incumbent upon us to determine what do we think is the data that would justify and address those two aspects, what is clinically meaningful and what is objective. And so with that, I’ll turn it over to Suku to just give you a flavor of the comprehensiveness and the totality of data that we’re looking at and why we’re encouraged. Suku?
