So they basically had to stand on their feet and toes. Importantly, we took x-rays of all patients in the study. And even those who did not meet that definition of severe Pes Cavus, did have Pes Cavus in that they were different than the literature references for patients who do not have Pes Cavus. Recall that MOXIe Part 2, the primary analysis population did not include Pes Cavus, severe Pes Cavus, yet we saw a treatment effect in patients with severe Pes Cavus, Importantly, in our propensity match analysis and reference the preprint that is available online with a pre-submission manuscript. Out of the 136 patients, a meaningful proportion of patients did meet the definition for severe Pes Cavus, and we do see a treatment effect in those patients.
That is statistically not different than patients who did not meet the definition of severe Pes Cavus, and so for all those reasons, we believe that patients who do not meet the definition or patients who did meet the definition of severe Pes Cavus would be included in the label.
Operator: Our next question comes from Charles Duncan from Cantor Fitzgerald.
Charles Duncan: Warren and team, lots going on this morning, so I apologize if I missed it. I’m just kind of wondering if — I think you’ve referred to some post-marketing requirements. Would you see that as typical for Friedrich’s ataxia patient population or specific and driven by any observations on Omav? And then my second question is related to manufacturing of Omav. Have those manufacturing facilities been inspected? And are you relying on a single site or multiple sites?
Warren Huff: Sure. I’ll take the… I’ll take the first question, and I’ll ask Manmeet to respond on the CMC. So I think with respect to the post-marketing commitments, those are going to come from for several sources. First, they gave us quite a bit of dispensation when we submitted the NDA in that they allowed us to, for example, as a post-marketing requirement, do certain work on metabolites of omav post-approval carcinogenicity studies, they gave us dispensation on that, that those could be submitted post approval. And then specifically, they requested in this late-cycle meeting, they anticipated that they would be requiring, as I mentioned, a drug-drug interaction trial with CYP3A4 modulators, that’s because of the impact of the drug in connection with those, thorough QT trial as well as an evaluation of the pregnancy outcomes.
They’ve also mentioned that although they haven’t identified any major safety concerns and they clearly stated that they had no issues related to the risk management identified to date and also they do not see the need for RIMS, they’re still considering whether they need to have some characterization of the long-term effects of omav on the liver and the heart because of the observed clinical chemistry changes in transaminases and BNP, we would plan to address that. We had already proposed a registry study. We would propose to address that in tracking outcomes in a post-marketing registry study. So I think these are fairly straightforward based on the standard requirements for approval as well as observations that have been made during the review.
Charles Duncan: And then regarding manufacturing.
