Jason Gerberry: Hi, guys. Thanks for taking my questions. Just a follow-up on that last question. So is efficacy in the ballpark of PRAISE something that gets you in the right zone of a discussion regarding ability to file based on PRAISE for ZEPHYRUS-1. And then, Enrique, when you talk about the IPF market, a lot of the shortcomings of the current standard of care therapies has brought up and the tolerability issues. And what I wonder is even if you don’t assume any increase in treatment rate, so you still have a third of new starts getting treated. I’m just wondering how big could the market be if these drugs had a more appropriate duration of therapy that might be commensurate with a drug that’s reasonably tolerated. Just wondering if you sort of increase that duration of therapy, toggle, how big could that market be?
And then just lastly, client had some data, and they’re going to have 24-week data in 2Q, I believe. Just wanted to get your thoughts just on what you saw from the competitor approach. Thanks.
Mark Eisner: So the first question around efficacy. I think it’s important to remember when we’re framing a question that the current standard of care is limited by poor tolerability and specifically Gl side effects, nausea, diarrhea and those sorts of things. So, we expect pamrevlumab to have a much better tolerability profile. So, we have to think about both the benefit and the tolerability when answering your question. The second point is, yes, we are aiming to replicate PRAISE and we’ve kept the design similar in terms of the primary endpoint of 48 weeks in both Phase 2 and Phase 3. FVC is the end point. But it will be a totality of the results, right? It will be the primary endpoint, the secondary endpoints and the tolerability together determine the overall benefit risk profile.
So, I don’t think it’s as simple as saying no particular threshold on FVC because it’s going to be kind of the comprehensive look at the product. And I’ll turn the next part of the question over to Enrique.
Enrique Conterno: Sure. So, I think your question was, given the introduction of a product, if I understood the premise of your question, that may have better tolerability, how could that impact the overall market size? We have to look at the overall profile of the product, right? But that includes the efficacy. And as Mark stated, we — our intent is to replicate PRAISE. But assuming the profile of the product has the — replicates the efficacy and good tolerability profile, I think we have to start by thinking about, okay, if 40% to 50% of the patients are discontinuing therapy within the first year, you can imagine that, that’s a significant driver for many of those patients to go into a new therapy. Those patients were already multi-compelled to seek a treatment.
And now we’re basically offering an option that is highly — potentially more efficacious even though we won’t have head-to-head trials and with a good tolerability profile. But I think we also need to think about the patients hat are not being treated today. I think we have to think about the full opportunity for the product, because out of 30,000 patients, this is he U.S. that we’re talking about that are diagnosed every year, only about one-third are being treated with the antifibrotics. So, the expansion of the treatment rate, I think, is also a significant opportunity for PAM to be able to offer a benefit risk profile that is different from that of the other products, and significantly enable meaningful overall market growth. So we think about our opportunities, this is probably the one area that we’re trying to emphasize with investors where we see an opportunity that is larger than maybe what’s reported out there given the dynamics I just mentioned.
