Danielle Brill: Hi, guys. Good afternoon. Thank you so much for the questions. I guess, first, I want to clarify. You said a few times now that you’re powered to replicate PRAISE and the ZEPHYRUS trials. But there seems to be clear precedent that effect sizes are lower in Phase 3 versus Phase 2. So I just wanted to clarify, did you consider this and other potent factors that may impair treatment of excise when you powered the trial. And then I have a couple of follow-ups. Thank you.
Enrique Conterno: Yes. Let me just quickly address this. Yes, we did. As Mark mentioned, we are very well powered, while our intent is to replicate PRAISE. When we power, we basically did some discounting of the FVC and we still powered over 90%. So we took some of those dynamics that you referenced into account.
Danielle Brill: That’s very helpful. Thanks for that clarification, Enrique. And then another question that comes up when talking to investors, is the potential impact of COVID and potential data integrity issues that may arise given the study was conducted throughout the pandemic. Can you just comment on measures that you took to mitigate any missed infusions or dropouts in the study?
Mark Eisner: Sure. So First of all, I think — I mean you’re right, COVID has been a challenge over the last few years. I think one point to consider is that patients with IPF, because they have severe underlying lung disease are counseled by their physicians to be cautious and to avoid exposure, thereby minimizing the risk of infection. So, we’re expecting that, that will help to mitigate the effect of COVID and its impacts on these patients. But we have taken a lot of careful approach to maintaining patient recruitment — I mean, patient maintenance on the studies, we have allowed some flexibility in terms of follow-up visit windows, things of that nature, which regulatory authorities have allowed for. We’ve allowed home infusions in countries where that’s allowed.
So we’ve taken a lot of measures to be really thoughtful and to try to do our best to keep patients on the study and maintain data integrity. And we are confident that we will have a very robust data set at the end of the trials.
Danielle Brill: Excellent. Thank you. And maybe I can just squeeze in one last one on manufacturing. I know you switched manufacturers for pamrevlumab. Will you have commercial manufacturing in place by the time of launch? And are there any FDA requirements for bioequivalence or dosing needed prior to approval? Thank you.
Enrique Conterno: Yes. Thank you. Yes, the answer is yes. We believe we will have — be able to have commercial products manufactured at expected launch dates — so we’ve made quite a lot of progress on our manufacturing capabilities. As you know, we’ve conducted a tech transfer with Samsung. And I believe that has gone very well. So at this point, I think our thinking is that analytical comparability will be the only thing that will be required for us to be able to utilize the commercial product from Samsung.
Danielle Brill: Got it. Thank you for the questions.
Operator: Thank you. Our next question comes from the line of Yaron Werber of Cowen. Your question please, Yaron.
Yaron Werber: Great. Thanks for taking. Enrique, I got a couple. Maybe just the first one, just to follow up on the last question. The analytical comparability, is that something you can do in parallel to the Phase 3? Has that been done already? Or is that a part of the Phase 3? And can you confirm that you actually are using supply out of Samsung in at least one of the Phase 3s. And then secondly, on the MATTERHORN study, the data we’re going to get, I believe, is the 24-week data. Can you file on that? Or do you need to wait for the 52-week data for MDS? Thank you.
