Javier San Martin: So we’re going to use the totality of the data available to estimate the placebo rate and that would be part of the equation for the effect size and the power for that study. So you will see that in detail whenever we can do this event with Takeda and present the SEQUOIA data and the Phase 3 study design. So we, of course, use the totality of the data to plan for that study.
Operator: And our next question comes from Keay Nakae from Chardan.
Keay Nakae : Chris, one question on AATD, the Phase 3 design, is it your expectation that the agency will or will not require care biopsy data?
Javier San Martin: Yes. So the biopsy data is likely to be the key endpoint. That’s where we will — we’re thinking, that’s what we studied. That’s what the disease is defined by. So this is a disease of fibrosis progression and ended in end-stage liver disease with fibrosis. So the goal of therapy is to prevent fibrosis progression or to reduce fibrosis severity. So that seems to me a logical approvable endpoint in a condition that is defined by fibrosis progression.
Operator: And our next question comes from Mani Foroohar from SVB.
Mani Foroohar : I’ve got a couple of questions more about your own sort of rationale and strategy given that a lot of the analysts have dug into the details of this or that specific program. So I’ll start with SEQUOIA. Did I hear right that that your plan is to disclose the upcoming SEQUOIA data green biopsy alongside the Phase 3 trial design? And if so, could you give me a sense of the rationale of why those two should come out at the same time? And then secondarily, there’s been a few people who’ve asked about your strategy around running CVOTs, which assets to hold on to or not. Can you give me a sense of what your ballpark estimate around the size, cost and the operational burden of a CVOT would be for you? And how you guys think about the number of studies of that scale that you could run for your assets simultaneously?
Christopher Anzalone: Sure, So the first question is — I’ve got more on the first question than the second question. So look, the — having a complete data set for SEQUOIA and having clarity on what the Phase 3 looks like just happened to come out at around the same time. And so it made sense for us to present both of those at the same time. And I think they’re both related, of course, and they feed on each other, of course. If there was a big time delta between the two, we would have been happy to separate those. But it just turns out that, again, the SEQUOIA data are analyzed and we expect to have final clarity on the Phase 3 data at about the same time. So it makes sense to do this together. And we’d like to do them in conjunction with Takeda.
That makes sense as well. We’ll just see when the calendars will align for that. With respect to the CVOT outlook, we haven’t given any guidance on how large a study would be and how much would cost yet, in large part because we haven’t had those end of Phase 2 meetings with the FDA. We really want to start to have these discussions before we opine on that because there are several ways you can do a CVOT, of course. And it just feels a little bit early to opine on that. We will give guidance on that once we have it. But we just — we’re still pretty early here. We’ve got an interim look. We have a pretty good idea about what the data we think are telling us. And then we still are going to run these studies out to the end and then have end of Phase 2 meetings.
And so I expect that next year sometime we can give you better guidance or some guidance on size, cost, et cetera, for the CVOT.
