David Zaccardelli: Great. Thanks for the question. Let me take the second one first, and then I’ll turn it over to Chris on sort of the patient journey. Besides our combination product, which we’re definitely focused on, and we think is another advance for ensifentrine. We are looking at other diseases as potentials. We also think other indications may require different formulations as well, possibly different dosing. So I think that some of that is going to be helpful to be informed in our partnering strategy and working with partners that may have IP on different devices and expertise on different devices. And so some of that is staged and going to be following as we progress the nebulized formulation. But we are attentive to it.
And again, I’d expect more clarity on that as we get through 2023 and into 2024. And as we have an eye towards the approval of ensifentrine then the launch in COPD, I think other indications open up as well. So that’s our general plan on R&D. So Chris, do you want to comment on the patient journey?
Christopher Martin: Yes. Thanks, Dave. As we think about the patient journey, the patients are typically treated based on two pathways. The first pathway is really a symptom-based pathway where if they have disease the primary driver of symptoms and issues, then a physician moves down a treatment algorithm there. The other pathway is exacerbations. What we know from our market research is that the patient typically sees the physician between 2 times and 4 times a year and that the overall symptomatology of the patient will drive therapy changes. So if a patient is having increased inability to breathe and really what the physician talks about not only is the inability to breathe, but it’s the inability to do certain activities or if their activity level is changing, the physicians will make therapeutic changes.
So when I look at that, journey, there are significant opportunities for ensifentrine to be inserted into a patient’s treatment algorithm over the course of a year. I think the important thing there is ensifentrine, you don’t have to wait until the patient is on a dual or triple ensifentrine can be inserted into the treatment paradigm very early, and the data supports ensifentrine being added to a LAMA or LABA or a LABA/ICS in a very early situation for these patients. And the great thing is that physicians are looking for products that can help the patient kind of continue to keep some sense of normalcy in their life through either a reduction in symptoms or improvement in quality of life, an improvement in FEV1 or the potential for help with exacerbations as well.
So as I look at the treatment journey, we see multiple intervention points over the course of the year, both early in their treatment cycle but also late in a patient’s treatment cycle where ensifentrine can be inserted.
Edward Nash: Great. That’s very helpful, thank you.
Operator: The next question comes from Joon Lee from Truist Securities. Please go ahead.
Unidentified Analyst: This is Jeremy [Ph] on for Joon. Thanks for taking my question. Two quick ones for me. What do you see as the greatest risk to the approvability of ensifentrine? And what do you expect the SG&A ramp as you prepare for commercial launch? Thanks.
David Zaccardelli: Great. Thanks for the question. When it comes to risk in the submission, I think the regulatory process is inherently has its underlying risks that are quite broad and consistent across any new chemical entity. We feel we’ve handled that very comprehensively in the submission, all the way from how we view and data package and CNC, non-clinical, clinical data and, of course, the overall safety. So we spent an enormous amount of time to make sure that we were looking at that broadly, comprehensively. And I think we’re as confident as we can be that we’ve addressed all of those areas. Of course, during the regulatory process and feedback from the FDA. Of course, we’ll be highly responsive to items that may need to be addressed, if any.
