Serge Belanger: Hi, good morning. Thanks for taking my questions. I guess the first one, and apologies if I missed this in the prepared remarks, but has there been any additional interactions with the agency post the late January PDUFA date for the PH-ILD approval? Have they asked for additional info or given you any additional in information regarding their internal process for that potential approval? And then secondly, I guess for Rusty, maybe just talk about the Supreme Court decision to deny the Liquidia petition late last month, and just what it means to the overall legal proceedings. Thanks.
Roger Jeffs: Thanks, Serge. Good morning. I’ll break this into two parts. So, Rajeev oversees our regulatory group, so he can answer the first question regarding interactions with FDA. And then Rusty, if you’ll answer the Supreme Court question. Rajeev?
Rajeev Saggar: Yes, thanks, Roger. Hi, Serge. Good morning. So, in regards to our – we continue to believe very strongly, as Rusty already alluded to, that the amendment we filed to add on the indication for PH-ILD, remains appropriate. And in line with our discussions with the FDA, as you know, the only stopping gap was really the clinical exclusivity, which if we had received previous approval, that would lead to a tentative approval. Now, we anticipate that date is shortly arriving on May 31 when the clinical exclusivity ends. And therefore, the entire package right now will lead to now a full approval for both indications for PAH and PH-ILD, and we remain confident in that matter. I’ll turn it over to Rusty to answer your second question.
Rusty Schundler: Serge, thanks for the question. So, the Supreme Court case really has no bearing. So, as a reminder, that case was our attempt to overturn the original Hatch-Waxman decision on the 793 patent and raise some arguments that we think were overlooked by the lower courts that there shouldn’t have been a finding of infringement at all. Supreme Court didn’t take up that appeal, but again, it all relates to the 793 patent, which separately has been invalidated at this point, and now affirms really twice by the federal circuit. So, with that decision from the federal circuit, the decision of the Supreme Court really doesn’t bear on sort of how this is going to play out at all.
Serge Belanger: Okay, thank you.
Roger Jeffs: Yes, maybe, Serge, I’ll just add a little bit to Rajeev. So, I think, the one communications we’ve had, obviously we missed the January 24 PDUFA action date. And the reason for that has been communicated is that the FDA is awaiting for the injunction to be removed. So, as Rusty said, there’s two things that need to happen principally for us to get full approval, which is the injunction removed and then the potentially the clinical exclusivity to expire at the end of March. So, as Rajeev said, we’re looking now. The amendment was filed and asked for full approval even when we filed it in July for both PAH and PH-ILD. So, it’s our expectation now that we’ll skip the tentative approval phase and probably just go to a full approval after the March 31 clinical exclusivity expiration. Operator, next question, please.
Operator: One moment. And our next question is going to come from the line of Matt Kaplan with Ladenburg Thalmann. Your line is open. Please go ahead. Mr. Kaplan, your phone could be on mute.
Matt Kaplan: Oh, thank you. Yep. Good morning. And Roger, just to follow up on that question in terms of – and thank you, Rusty, for the detailed play by play in terms of the moving parts here in the litigation. But in terms of the critical path and Judge Andrews lifting of the injunction, can you give us some more detail in terms of the moving parts there and how that portion of it will work? Obviously, the regulatory exclusivity expiration is just a date on the calendar, so that’s easy.
Roger Jeffs: Yes, and Rusty can fill in here, but again, we feel Judge Andrews actually has all he needs now, Matt, to remove the injunction. The December 20th affirmation by the federal circuit Court of Appeals should have given him the power to remove it. And I think he was just waiting to see the rehearing request denied, and then the mandate to issue, which will happen next week. I think next Tuesday is when it should issue. So, at that point, he’ll be fully empowered to do what he needs to do. Whether or not – I think, Rusty, you can comment on how you see the pending PI, how that interplay may impact this.
Rusty Schundler: Yes. So, Roger, on the existing injunction, what you laid out is exactly correct. Again, it’s been fully briefed in front of Judge Andrews so that he has what he needs. We also yesterday supplemented what we had submitted to him to provide him the denial to rehear and request that was issued by the federal circuit. So, again, he has all the information in front of him. And obviously, they have the new case, the 327 patent case where they’ve also requested a preliminary junction. Those cases really don’t relate to one another. They’re both in front of the same judge and obviously the patent system similar, but procedurally, the injunction that currently exists isn’t tied to their request for a new injunction on the new patent. So, I don’t think there’s any interdependency there between the two actions,
Roger Jeffs: And Matt, that’s why we’re not giving a specific day when we think the approval action will happen, but again, other than it’ll be after March 31 when the exclusivity expires.
Matt Kaplan: Right. Okay, great. And then shift gears a little bit in terms of L606. Can you give us some more details in terms of the regulatory pathway there? You described only needing one additional study for approval in both PAH and PH-ILD. Can you give us a sense in the terms of the timeline of that as well?
