Warren Huff: I would just also add, they didn’t raise any new issues, either efficacy or safety for approval and just stated that the existing issues were under continuing review. They didn’t request us to submit any additional data — and they also noted that there were no outstanding information requests that we hadn’t satisfied.
Madhu Kumar: Okay. And then kind of beyond this initial regulatory process, how should we think about kind of the plans for a pediatric trial? And what do we need to see in terms of — and when we can expect to have a pediatric trial to start? And how would that trial be different? And what have you learned from MOXIe Part 1 and Part 2 to influence the pediatric trial?
Colin Meyer: Yes. So this is Colin. So in our negotiations with the European authorities, we had to reach agreement on our proposed pediatric plan in order to submit our MAA. And so we are actively planning to initiate a pediatric set of studies. Obviously, first, we have to make sure we are giving the right dose that is associated with the appropriate exposure to what was achieved in adults. And then we will do a study to assess efficacy. This will be done to not only satisfy the European requirements. But obviously, our age range was limited to a minimum of 16 in MOXIe Part 2. And we note that there are younger patients, and so we would like to be able to lower the age range in any future… Label.
Warren Huff: Yes. I’d just like to add to that, that we’re aware we’ve received a lot of feedback from the patient community, both in the U.S. and abroad, that they’re very anxious to have the drug be available to patients below that 16 age group. And so we’re very aware of that and are very committed to moving forward with the pediatric study.
Operator: Our next question is from Yatin Suneja from Guggenheim.
Yatin Suneja: Just a question on the efficacy front. I think last time, you had said that the FDA continues to have comments on efficacy and then the MOXIe trial, maybe were insufficient to support a single study approval. So during this late cycle of meeting, any color, any discussion around that, how does the FDA think about the efficacy side now? And then the follow-up question I have is with regard to the Pes Cavus patient population. Will that be part of the label? Are you including it? And then how you are facing that?
Warren Huff: Sure. Yes. I think when they — in the late cycle meeting agenda and in the comments, they made in the meeting, those they’re directly related to the meeting the standard for approval. Of course, we have a single adequate and well-controlled study. And then the issue is the additional evidence that we’ve provided in terms of the mechanism of action data, the natural history data using, for the propensity matched external control and the delayed start analysis, do those satisfy the requirement for confirmatory evidence? I believe that is what they are reviewing. Have we met that standard under Phenomenal 115. And in regards to your question about Pes Cavus, I’d like to first clarify that the definition that we use for Pes Cavus and MOXIe Part 2 was severe Pes Cavus, — and so patients had to have complete loss of lateral support their feet.
