Rajeev Saggar: Sure. Thanks Kambiz. So first, yeah, just to re-highlight, we remain quite enthusiastic about YUTREPIA using our PRINT formulation, as well as a low-resistant device. We believe that this will be quite differentiated in the market especially in the PH-ILD market. We have always discussed that some of our key pillars that YUTREPIA offers are improved tolerability. As Roger alluded to dose does matter and we continue to highlight that YUTREPIA remains quite titratable in our open-label extension study, which is known as an INSPIRE study. We have now reached doses equivalent of 30 breaths of Tyvaso four times a day, which is just quite remarkable to see these high doses being used safely in these patients. And we believe all of these will portend to improve clinical outcomes for patients both in PH and PH-ILD.
And most importantly, we show durability with the use of YUTREPIA with now patients being exposed for as long as up to 5.5 years, which we believe highlights the durability and compliance with this – with YUTREPIA itself in this population.
Roger Jeffs: Great. Thank you Rajeev. Rusty if you’ll speak to the status of the patent.
Rusty Schundler: Sure. And thanks for the question Kambiz. So, the ’61 I think you’re referring to the patent application that received a noticeable a United Therapeutics patent application that received a notice of allowance back in late June that we issued an 8-K about. As of today that patent still has not issued and they’ve not yet received a notice of issuance. That’s a little bit atypical for it to take that long for that patent issue. So, we’re not — we don’t have visibility as to what’s going on at the United States Patent Trademark Office with respect to that patent. However, what I will say is we’re anticipating that we’ll issue we’re preparing for it to issue and we’ll be ready to address it.
Kambiz Yazdi: Great. Thank you.
Roger Jeffs: Thank you, Rusty. Operator, next question.
Operator: Thank you for your question. Our next question comes from Julian Harrison of BTIG. Your line is open.
Julian Harrison: Hi, good morning. Congrats on the progress and thank you for taking my questions. I have some related to the last one just asked on the PH-ILD patent. United received notice of allowance for it back in June. I guess after the FDA designated PH-ILD exclusivity expires for United end of March next year could this patent or patent application have any relevance to YUTREPIA eligibility to receive full approval in PH-ILD assuming you already have full approval in PAH at that point?
Roger Jeffs: Yes. So, I’ll speak to the regulatory component. So, in terms of we have a PDUFA date Julian January 24, 2024 for PH-ILD the amendment that we filed in July. There would be no implication in terms of getting a tentative approval which would be granted at that time because market exclusivity does not expire until end of March 2024. So, we don’t see any gate between whatever may happen with that patent and the regulatory approval process. Rusty you want to speak about the commercialization post that?
Rusty Schundler: Sure. So, Julian thank you for the question. So, to be clear there would be no 30-month stay that catches to this new patent. So, the only way it would potentially have an impact would be if United Therapeutics is able to go into court and convince a judge that they should get some sort of an injunction to prevent us from launching. As I think we said in the last call looking at this patent looking at how this patent compares to the 793 patent and the numerous studies that were done by medical professionals between the launch of TYVASO and the date that this new patent was filed we think there’s a lot of prior art. Obviously, if they assert it, which we anticipate they will we’ll have to deal with that in court. But again the only way it would impact us if they’re able to convince a court that notwithstanding all that prior, they should be entitled to an injunction .
