Manmeet Soni: Carter, I would add one more thing, which I know we are working very actively is as you see the payers, right, we have been very actively engaged with the payer community and increasing awareness of both Reata and omaveloxolone and Friedreich’s Ataxia, right? All that has been initiated, and we believe that will help us in a smooth launch as we proceed in the next coming quarters?
Warren Huff: Yes. So I’ll take the question on bardoxolone. Of course, we were very disappointed to receive a CRL for bardoxolone in Alport syndrome. My personal belief is that the principal issue that we have had with the approval of bardoxolone is that it’s so novel, the acute improvements in eGFR, which are driven by improving mitochondrial function in the kidney is a very different approach that’s been taken and the improvements have been unexpected. And obviously, it raises the question of whether those are driven by pressure being pressure-mediated or some other effect that might be harmful in long-term dosing. The AYAME study should definitively answer that question. It’s a very large study, over 1,000 patients, the PMDA in Japan, asked our partner, Kyowa Kirin to run the study so that every patient would have at least three years of exposure.
So that means that most patients will have at least 3.5 years of exposure to the drug. It’s large enough to collect — to give a read on outcomes, both positive or negative. And so if that study is positive, I would say, if it’s unequivocally positive so that there’s a meaningful reduction in the events that have been validated to predict the risk of end-stage renal disease. I think that will change the landscape for bardoxolone. And I think that data could be important in re-engaging both with the FDA as well as with the regulatory agencies around the world and the nephrology community. I think the data will be important in answering this fundamental question about bardoxolone — did that answer your question?
Operator: Our next question comes from Annabel Samimy from Stifel.
Annabel Samimy: Just a couple here. So first on omav, I know that when you submitted the additional three-year data. One of the reasons was to answer a question for FDA that it wasn’t patients who discontinued, but patients who just hadn’t been followed up in a timely fashion due to COVID. Will you be required to submit any further patients who have completed three-year data just to complete the set of the data set? And then secondly, just as you talk — think about the launch and you mentioned the payer that you’ve been having payer discussions — can you describe what you expect the onboarding process to be? I mean I know that the patients are pretty well just identified and it’s a tight population. So they should — that should be really a problem to raise awareness among them, but maybe among payers, how difficult process do you expect that to be and the timing of onboarding from the time that you launched to getting first patient in.
Warren Huff: Yes. I think — yes, I’ll have Colin address the Delayed-Start Analysis question and on address the onboarding question.
Colin Meyer: Yes, Annabel. So to answer your question, the FDA has not made any additional request for any new data since we submitted updated data after the mid-cycle meeting. And I believe your question is in reference to the delayed start analysis where FDA questioned whether or not the low in at certain time points was due to patients who discontinued or simply missing data due to COVID. And so recall in the mid-cycle meeting, we clarified that the discontinuation rate had been low at only approximately 16% and that the vast majority of patients still continue in the study, and since COVID has been impacting the country less, patients have been able to come back. And because of that, we have additional data at the later time points as well as that new time points that further demonstrate separation in the Delayed-Start analysis. So for all those reasons, FDA thus far has not requested any additional data. Dawn?
