Louise Rodino-Klapac: Strong preclinical data with both approaches and as Doug mentioned, we’re planning to start two clinical studies on both approaches. So this has been important to us to make sure that we can serve the entire community.
Operator: Thank you. Our next question comes from Hartaj Singh with Oppenheimer and Company. Your line is now open.
Hartaj Singh: Great. Thank you. Thanks for the question. I’ve just got a quick question on the VOYAGENE study LGMD. Assuming you get that Phase 3 started with commercially represented material by the end of the year, how much insight will the Phase 2 and Phase 3 give you into the other LGMD; I mean, could you move faster, could regulators be amenable to looking at them sort of holistically versus very separately? And then how easy will it be to scale the manufacturing for all the LGMD? Thank you for the question.
Doug Ingram: Yes. When I say broadly, one’s seen public presentations from Dr. Peter Mark’s. You’ll know that his ultimate goal, his long-term goal is to get to a place where you can build therapy upon therapy and particularly if you’re using the same capside which we are in connection with the LGMDs that you should be learning from each and then being able to greatly shorten the timelines. And I think that a form of that will occur with our limb-girdle. But we are on the early days of limb-girdle, so it won’t be fully formed like that as we’re – we are moving through. We do get significant value and learning from each of these programs that we apply to the next one, the limb-girdle are benefiting enormously from 9001. Remember most of our limb-girdle, the majority at least use the same promoter as 9001, and they all use the same capside rh.74.
So there is this virtuous cycle where we ought to be able to start moving faster and faster over time. It’s going to take some time to do that. I would say we, and finally I’d say on manufacturing we definitely benefit from prior knowledge as we move forward, but each of these programs is its own program and requires some bespoke elements including for instance much of the assay work. Some of the assay work can be very translatable, but a lot of this assay work is bespoke from program-to-program, and so that does take some time and it will take some time with respect to some of these little hurdles.
Operator: Thank you. Our next question comes from the line of Debjit Chattopadhyay with Guggenheim. Your line is now open.
Debjit Chattopadhyay: Hey, good afternoon and thanks for taking my question. I just wanted to clarify one of the comments you made in your prepared remarks. You brought up EMBARK in the context of the Adcom. Could you clarify and frame that question again?
Doug Ingram: Oh, I think. Oh, yes, the – one of the issues that we just need to discuss at the advisory committee is that EMBARK, which is our proposed confirmatory trial, and obviously needs to complete and complete on time. And so one of the obviously reasonable questions, one would pose is, are you confident that if we give you an approval now on an accelerated basis, that EMBARK will in fact complete that there won’t be something about the approval of this therapy that would somehow influence the ability to successfully complete EMBARK? As you know, EMBARK actually was fully enrolled as of last year – September of last year, so I think relative to other accelerated approval therapies we are in a particularly advantageous, brilliant position with respect to the completion of our confirmatory trial.
