Rajeev Saggar: Sure. Thank you. Thanks for the question. Yeah. Just to reiterate what Roger is saying, we — the guidance that the FDA has provided us in the past highlight the fact that we do not need any new clinical study for amending the application for PH-ILD. In regards to YUTREPIA, we believe that one of the biggest unanswered questions is the use of a dry powder formulation of treprostinil. In these patients with PH-ILD, remember Tyvaso was originally approved, using the nebulizer. So, we believe studying that in a prospective, open-label fashion, will definitely provide some of these unanswered questions about the utility of YUTREPIA, especially given through our low resistance inhaler. These will answer several clinical questions.
One, we believe these — this will highlight our improved tolerability profile, which we saw in our INSPIRE study in PAH, and we believe we anticipate similar outcomes. With this is also highlight our ability to titrate the drug to higher doses, which we believe is important to continue to show improved clinical improvements in basic endpoints such as walk distance. Again, we believe these patients would benefit from a more portable device, such as YUTREPIA. So, we believe all those facets are going to be extremely well, well perceived by the PAH community. And in regards to the study, we still believe that this — we are — we have noted before that the study will initiate near the end of 2023, specifically in the United States. Thank you.
Julian Harrison: Great. Thank you.
Roger Jeffs: Thank you, Julian. Thank you, Rajeev. Next question, please operator.
Operator: Our next question coming from the line of Serge Belanger with Needham. Your line is open.
Serge Belanger: Hi, good morning. Just a couple questions. I guess, the first one on the recently filed MDA amendment for the PH-ILD indication. Just wondering about the next steps, is it kind of the standard FDA acceptance within 60 days? And do you expect a tentative approval from the FDA? I think you’ve talked about a six month review process.
Roger Jeffs: The 30-day clock before they will indicate to us whether it’s a type one or type two submission. Type one would be granted a two-month review and a type two submission would be granted a six-month review. We feel that it could be a type one resubmission. But again, we’ll just wait to see what the agency says because the 30 days will come up in mid-October. But the good news there is then we would get potentially tentative approval for PH-ILD as early as October, or as late as early 2024, which again, we would be prohibited from launching into that indication until the [indiscernible] market exclusivity ends in March of 2024. But that’s the basic timeline. I think the other thing to point out, Serge, the question is that the tentative approval for PAH remains, and this is just an amendment to that tentative approval for PAH seeking tentative approval at this time for PH-ILD.
Serge Belanger: Okay. And just thinking ahead of YUTREPIA launch, do you see the opportunity here as a kind of a switch — switching from Tyvaso or it would be more of new patient starts that would begin with YUTREPIA, and does that differ between PAH and PH-ILD?
Roger Jeffs: I think, it’s largely a new patient start paradigm. I think, what — the way we view this is we want doctors to use it a few times, get comfortable with its use in a patient, quote unquote, who’s de novo to prostacyclins. And then once that comfort base exists, then potentially they would switch. But I think the real opportunity here as we see it as more in the de novo patient base. There’s a lot of turnover here. As you know, patient — this is an unrelenting disease. Patients come on and come off the drug, their drugs commonly over time. So, for us, it’s more going after the de novo market. The market that’s already on a process like and can be a little bit stickier. I think we’ve acknowledged that. So, it’s less about switches.
