Louise Rodino-Klapac: Yes. Thanks for that question. Certainly, in — we’re looking at this closely. This is an ultrarare indication and so we’re looking at all the data we have to date in both the ambulatory population and now this new population that we’re spending which is the older ambulatory and non-ambulatory. And so the totality of the patient population could be captured in that Phase III design. So we don’t have it finalized yet. But all of the results from these 2 trials will be taken into consideration when we have the ultimate study design for that Phase III study.
Operator: Our next question comes from Yun Zhong of BTIG.
Yun Zhong: So my question is actually also on the limb-girdle program. And I was wondering, what is the purpose of the Phase I study? And what kind of information are you trying to get? And given the small prevalence of the indication, what’s your thinking on the patient allocation enrolled patient into the current study? I don’t believe you have disclosed the size of the study versus maybe saving patients for future pivotal study.
Doug Ingram: Yes. I’ll touch on it briefly and then I’ll — Louise can answer it and correct me when I get this wrong. I mean the reason that we’re doing — there are 2 reasons why we’ve done this clinical experience study. The first is that it gives us an opportunity to explore the safety and expression of the therapy in a broader patient population than we would typically do for our pivotal trial itself. So we will glean important information. And the second reason that we did it is that we had clinical material available to us. So for the pivotal trial, we need to have commercially appropriate material and that has to be material. That would be appropriate. So the launch of the therapy, we have very appropriate clinical material right now and it seemed appropriate to make good of it to get additional insight and also, frankly, to provide a benefit at the same time. Louise?
Louise Rodino-Klapac: I think you characterized it well. Just emphasizing that this is a different patient population than we’ve previously studied in older patients where we can look at safety and efficacy in non-ambulatory and older ambulatory which is an important component of this preplan population.
Operator: Our next question comes from the line of Kristen Kluska of Cantor.
Richard Miller: This is Rick on for Kristen. In the press release, you mentioned that the Catalent agreement structures how Catalent could support multiple gene therapy candidates in the LGMD pipeline. So could you maybe go into a little detail here on what this might mean in terms of whether this could deal with clinical-grade material or potentially commercial-grade material for later-stage trials in LGMD?
Doug Ingram: Yes. Relationship with Catalent our goal is to — they would potentially have the opportunity to manufacture for us to limb-girdle. Really, our goal going forward is to try to have commercial represented a material from the first inpatient clinical trial. Historically, as we evolve from Nationwide Children’s Hospital, as you know, the first study with 9001 started with clinical material there. Likewise, 9003 started with clinical material provided by Nationwide. But the fastest pathway forward is to have commercial representative material from the beginning and that’s going to be our goal. And the potential of doing that with Catalent is a significant one.
Operator: Our next question comes from Gavin Clark-Gartner of Evercore.
Gavin Clark-Gartner: Phase II excluded exons 1 through 17. But as you noted, you’ve been dosing patients inside that range. Have you had any discussion FDA on getting some of those exons included in the initial label? And is there any chance that something in here could represent a major amendment?
