Whitney Ijem: Thanks for taking the question. So for GAN, you kind of listed out a lot of additional endpoints, functionally biomarker, et cetera that you’re looking at. And I’m just curious, are those things that were selected all the way along hadn’t been analyzed or focused on, or are those things that you are calling patients back in now to look at and will be comparing to natural history? And then part two of my one question is, is the goal there to kind of continue the dialogue with the FDA, use that data to potentially support filing or use that data to design another study?
Sean Nolan: So I’ll take a first hand of that, Suku, and feel free to opine. I wanted to answer the first part of your question. This is data that’s existing in the database. So these are patients €“ remember there’s been 12 patients that have been treated. We’ve got the natural history before they were treated, and then all the study visits over the course of time in some cases many, many years and there are a multitude of assessments that were done. And what Suku’s team has been doing is, is comprehensively and systematically going through all of that data to fully assess it and to see if there are additional data points that can or metrics that can augment and further demonstrate the clinically meaningful effect and the objective measurement effect of the treatment on these patients suffering from GAN.
And to answer your second question, I’ll turn it over to Suku. The idea would be that we would submit a formal meeting request this quarter €“ the second quarter to dialogue with the FDA about this data and we will put forward after we fully have analyzed this €“ our view on what we think is the appropriate pathway forward. And that could very well be trying to seek approval with the existing data. So we haven’t made a final determination yet, but we’re encouraged by the data that we’ve gathered thus far and how it’s starting to line up. Suku, what would you add or clarify to what I said?
Sukumar Nagendran: Yes, Sean. Thank you. So as you highlighted, it’s an ultra-rare disease with no available treatment, very small patient population, and the patients are treated €“ in general, they were more than six years of age. So what we’ve observed is a slowing of disease as we’ve all previously talked about when it comes to MFM32. And as Sean pointed out, there were many efficacy endpoints in the protocol that the NIH designed, and it’s that dataset that we are looking at when it comes to functional, biological and electrophysiological endpoints. But we’re also doing some modeling work, and we think that comprehensive data analysis should give us enough information to go back to the FDA and request a meeting in the second quarter of this year for further discussion on what is the best path forward in a dataset that we think could really make a difference in these patient’s lives, especially given it’s an ultra-rare disease with no other treatments available.
So cautiously optimistic as we collect all the data work with the NIH, and then go to the FDA hopefully and hopefully move this program forward. Thanks for the question.
Whitney Ijem: Thank you.
Operator: Thank you. Our next question is from Jack Allen with Baird. Please proceed with your question.
Jack Allen: Great. Thank you so much for taking the question. I’m going to stick with GAN here. And I was wondering if you could provide an update as to where things sit as it relates to the Astellas option for GAN, how are you thinking about the ex-U.S. opportunity? And then what’s the turnaround time for the meeting request and who have you been meeting with specifically at the FDA? I’d love to get any insights there. It does sound like Peter Marks is quite optimistic about accelerated approvals based on a recent medical meeting that you are speaking at?
