Enrique Conterno: Yes. I’ll let Mark answer, I think, the second question. But analytical comparability is basically comparing the product on an analytical basis, right? All of the characteristics of the product when we look at product that was manufactured by Bl and the product that is manufactured by Samsung. So, it doesn’t require any study of that in clinical trials. I believe we’re in a really good position. Of course, we also discuss this with regulatory agencies. So at this stage, I think we feel good in terms of where we are from manufacturing and overall CMC perspective. I’m going to let now Mark answer the MDS question.
Mark Eisner: Sure. So the primary efficacy endpoint in MATTERHORN is at week 28, although the study goes through a week 52 for secondary efficacy endpoints and safety endpoints as well. So it is our plan based on the 28-week data, assuming that it’s positive to have the discussion with FDA about whether that data at week 28 would suffice for filing. But it’s our position that, that should be the case, but that would have to be dependent on the efficacy, the strength of the efficacy, the safety, the benefit risk and the FDA’s feedback.
Operator: Thank you. Our next question comes from the line of Annabel Samimy of Stifel. Your line is open. Please go ahead, Annabel.
Annabel Samimy: Hi, sorry, I didn’t hear the name. So just going back to a couple of the questions. Now I understand that you haven’t really disclosed what I guess, the FVC reductions you’re aiming for in your powering. But in terms of talking to physicians, is there a scenario, do they have some kind of, I guess, reduction or benchmark of reduction in mind or improvement rather in FVC where if it’s statistically significant, but maybe it’s lower than PRAISE or around the same range or maybe lower than the other products on the market, but they’re able to have a tolerable drug that patients stay on. Is that sufficient for the physician community if you have statistical significance in your trial. So I guess that’s sort of the first question I have.
The second is are you looking at any — can you remind us what specific fibrosis biomarkers that you’re looking at that physicians can also, I guess, appreciate benefit beyond just FVC improvement? That’s the first question and then one on LELANTOS.
Enrique Conterno: Clearly, our — I’m going to just provide a quick top line, but then I’m going to ask Mark to comment. But clearly, the intent that we have is to replicate PRAISE. And there’s been some discussion about whether in Phase 3 trials, sometimes the effect size maybe to decrease somewhat. That could be the case, but we’ve also made what I’m going to call some minor adjustments to the study, for example, lowering the FVC at baseline in terms of inclusion criteria, so that we can ensure that they are enrolling patients that are progressing and so forth. So, the intent is to replicate PRAISE. Now, I’m going to have Mark talk of your question in terms of what could be meaningful from a commercial perspective.
Mark Eisner: No, I don’t really think that physicians, when we talk to them, highlight a specific FVC threshold that would be necessary, right? I mean I think it’s as you said, we expect the tolerability to be much improved versus standard of care and patients can’t benefit from treatments that they can’t stay on. So that — we do think there’ll be a significant benefit with pamrevlumab in terms of tolerability. I mean we do expect to hit robust FVC results in terms of reducing the attenuation of FVC decline. And we also have other endpoints like the disease progression endpoint, the quantitative lung fibrosis by high-resolution CT scan, disease progression endpoints like acute IPF exacerbation, hospitalization and mortality.
