Operator: Next question comes from Yasmeen Rahimi with Piper Sandler.
Yasmeen Rahimi: Thank you so much for all the updates. Would love to dig a little bit more into these 2 new studies that you spoke about. I guess, where are you in the formulation process at this junction? If you could just give us some color beyond what you’ve said and how soon could you have it completed? And then what would a design — what would like the study design look like for a fixed condo? What would the duration be and the size, et cetera, and the same goes for the second Phase II study in the — that you’re also planning to kick off. So I think a lot of clients would love to hear maybe beyond the initial indication around size, costs associated with them? And what’s sort of the cadence of the next steps? Just a little bit more granular that would be really helpful for us.
Dr. David Zaccardelli: So let me just talk briefly about the formulation, and then I’ll turn it over to Kathy to talk about both the trial design concepts for fixed combo as well as for bronchiectasis. Within fixed combo product formulation development, we are advancing with the typical formulation development where we’re co-formulating both glycopyrrolate and ensifentrine and the nebulized formulation. Of course, there’s acute chemistry that we can look at. There’s also a longer-term stability data that gets generated at 3 and 6 months, typically under normal and accelerated conditions to convince us that we have a commercially acceptable on formulation. So that work is ongoing as we speak. Certain aspects can’t be sped up, especially when you’re looking at 6-month stability time point.
We expect to be more fully informed on the co-formulation somewhere in the first quarter of 2024. And that’s why we provided the guidance that we’ll be looking to initiate the studies actually for both fixed dose combo and bronchiectasis in the second half of ’24. So with that, I’ll give — turn it over to Kathy for her thoughts on the design.
Dr. Kathy Rickard: Sure. So let’s talk about first the fixes combination. So certainly, we’re in early stages of development of what a part of how will look like. We know what in general we would like to do or need to do in a Phase II type program, so the initial studies for that. So our goals will be to first establish efficacy and some initial safety and probably designs that are similar to our Phase II studies that we did for ensifentrine to begin with more likely be a shorter design maybe up to anywhere up to about 12 weeks or so. But also we need to establish dose ranging. So that would be the goal of the studies that we would do for Phase II is to look at initial efficacy and safety and dose-ranging. If you look at the second study, the study for non-CF bronchiectasis, the slot difference disease, slightly different type of design.
We certainly would need to establish in the Phase II, again, efficacy and safety. These studies may be need to be a little longer because some of the primary endpoints for non-CF access relate to exacerbations. So they may be up to a 6-month type of design. But again, keep in mind that we are in the early phase of developing these designs, and we’re starting to make more definite ideas about the designs as we get further along into our development program.
Operator: Our next question comes from Andreas Argyrides with Wedbush Securities.
Andreas Argyrides: A couple here. So and expectations of approval for ensifentrine, can you remind us what the label is likely to look like from an efficacy and safety standpoint? And then while you don’t expect an Ad Comm, the FDA has a curious history of changing its mind on a whim. Is there a threshold at which point and Ad Comm would definitely not be held? And if there is an Ad Comm, would it necessarily be a bad thing?
