Dr. David Zaccardelli: Great. With regard to the label for ensifentrine, again, just to remind everybody that we expect and have provided data to support an indication of the maintenance treatment of COPD, which is a fairly broad indication and consistent with recent approvals, and we believe the data provided supports that indication. We’d, of course, expect the rest of the clinical data results to be in the clinical section in the label as appropriate. Clearly, the FDA needs to continue the review, and we’re quite some time away from specific labeling conversations. And so I think we’ll see how that comes out. I’m sure in 2024. So — but otherwise, we think the indication is fairly broad. With regard to an Ad Comm. Yes, they’ve guided that they do not plan to have Ad Comm.
And yes, you’re correct. I think the FDA can decide on how they want to address that during the review. We don’t expect one as time passes by, especially after mid-cycle review, for example, and even as we get into 2024, that timing gets shorter and shorter. So there’s certain practicalities about it. But nonetheless, I wouldn’t comment any further on the Ad Comm. And of course, it’s in the FDA’s hands.
Andreas Argyrides: And just one last follow-up from us. With regard to the 2 new potential indications, maybe just some thoughts on how this potentially unlocks strategic value for the company and incident.
Dr. David Zaccardelli: Yes. Well, sure. I mean I think it speaks loudly to what we believe ensifentrine can do in — broadly in the treatment of COPD, either by itself or as a combination therapy. We have cleaned an excellent data from the ENHANCE trials that combining ensifentrine with a LAMA is quite advantageous as well. And so I think it speaks loudly to the power of ensifentrine, the PDE3, PDE4 mechanism and its application. And then, of course, broader than that and as we’ve reviewed today in non-CF bronchiectasis because of the underlying pharmacology, which has been demonstrated. So clearly, in COPD, we think it’s highly applicable in other diseases like bronchiectasis. I think ultimately, any partner can see that ensifentrine’s underlying pharmacology can be applied quite widely to various respiratory diseases, which we’ve really stated from the beginning as the full potential of ensifentrine.
Operator: The next question comes from Joon Lee with Truist Securities.
Unidentified Analyst: This is Asman on for Joon. My first question is, what are you looking for in a European partner? And can you guide to any updates on that front? And then also just wondering if you could talk about the ramp in SG&A in preparation for launch and one could expect hiring for the around 100-person sales force.
Dr. David Zaccardelli: Great. I’ll speak to the partnering and then turn it over to Mark to talk about SG&A and Chris, for the reps. But I think that with regard to European partner or, in general, our partnering strategy, it continues to be the same, that is we look to partner outside the U.S., much as we’ve done in Greater China with Nuance Pharma. So the strategy has not changed. I think that ideally in a partner, European or otherwise, besides, of course, elements around expertise in regulatory, clinical and commercial in the respiratory space, as you’d expect. We also are looking for opportunities in partners that have expertise in device PMD or DPI device development, manufacturing and/or IP, which I think could be quite advantageous as we look for the full life cycle management and other indications for ensifentrine as well as ability to manufacture specifically drug product, but also potentially drug substance or API.
And I think that this would serve us well having, of course, a second source potentially a source with a lower cost point. Keep in mind that we’re looking to supply the world with ensifentrine in different markets. And so looking for somebody with that manufacturing capability is another feature of our partnering strategy. So with that, I’ll turn it over to Mark for a ramp on SG&A.
