Dawn Bir: Yes. Thanks, Colin. And so to address your question related to payers and essentially them adopting omaveloxolone as a product on their formulary and available to patients for reimbursement. So we began discussions with payers back in March. And we focused on FA disease severity, educating and informing about this deadly disease, which most payers, quite honestly, did not have any understanding of. And so generally, we believe that payers will create reimbursement policies that will follow the approved label. And so our goal is to make sure that payers are covering omaveloxolone to label. And so that will take a little bit of time for payers to update their policies. So we’re anticipating anywhere between four and eight weeks. Some payers may move a little bit more quickly. But initially, we think it will take a few weeks. And then following several months of launch, we think that will take much less time.
Operator: Our next question comes from Maurice Raycroft from Jefferies.
Maurice Raycroft: I just wanted to clarify, at this point, has FDA commented on or provided reasons why they canceled your AdCom? And did it have anything to do with the Amylyx Advisory experience?
Warren Huff: They have not commented — they’ve not provided any specific reason for canceling the AdCOM. But obviously, the context of this is that in the mid-cycle meeting they commented about whether we had met the standard for confirmatory evidence. We went into the mid-cycle meeting prepared to address that issue with all of the data that — and analyses that Colin mentioned, the elucidating the mechanism of action of omav in the context of the pathophysiology of FA. We did the propensity matched, we proposed the propensity matched analysis, external control study, and we updated the delayed start analysis. All these were submitted as amendments to the NDA and — in addition to that, we did additional work on the secondary endpoints and provided them data on a global statistical test and how that would support — provide support from secondary endpoints, all of this went into them after that mid-cycle meeting.
As you point out, the Amylyx Advisory Committee meeting then did occur. And obviously, a lot of that meaning was about what the regulatory standard was for confirmatory evidence. And all we know is that after that, they let us know that they were not planning to have an advisory committee meeting, but they never explain their rationale in this context, just their decision.
Maurice Raycroft: Got it. That makes sense. And one other question just for the KKC Phase III IOMI data in first half 23, based on the baseline eGFR requirements for that study, which I think are lower than some of your other bardoxolone studies, what are your expectations for the readout? And can you provide more specifics on what Next Steps would be to leverage the data in the United States.
Colin Meyer: It’s Colin. And so obviously, there’s a lot of data that’s being generated within the trial. And so from an efficacy perspective, we would hope to see that bardoxolone — it reduces the rate of events in the primary analysis, which include actual dialysis events as well as confirmed 30% reduction in eGFR, which has been shown to be predictive of kidney failure events as well as confirmed eGFR of less than 6. And so best-case scenario, there’s a significant reduction in the primary endpoint that the secondaries are significant and that there’s no new safety findings. And so there’s actual dialysis events being accumulated obviously, in the primary endpoint. And so a best case scenario would be that those directionally favor bardoxolone.
