That team will, in addition, call on infectious disease physicians because, as we know, most of those ID physicians spend the vast majority of their time within the walls of the hospital. Now as a reminder, we’re targeting the hospitals, not to target the inpatient business, but as you said, rightly pointed out, rather the what I call the hospital to home segment, patients who may begin antibiotic therapy in the hospital, who are then discharged to complete their antibiotic regimen and then would also take SER-109 on the back of the completion of that regimen, therefore, in the outpatient setting. So that gives you a flavor of the type of physicians that we’ll be calling on post-approval, and we are finalizing our call plans currently as we approach the PDUFA date with our colleagues at Nestlé Health Science.
I hope that helps. Thanks, John.
Eric Shaff: Thanks for the question, John.
Operator: Ted Tenthoff with Piper Sandler.
Edward Tenthoff: Great. Certainly excited for the PDUFA date as well. I guess my question is without an AdCom, and I’m not sure that you’re at this point yet, but when it comes to label discussions, how can the conversation go around first recurrence, second recurrence, how important do you ultimately think that’s going to be to the launch and the initial success of 109?
Eric Shaff: Yes, Ted. Thanks for the question. I might ask both Terri and Lisa to comment. I will always preface our comments with — we don’t speak for the FDA and nor do we to speak to the label discussion. We have said — continue to believe that the right approach here is a recurrent label, right? And as we’ve said beforehand, physicians tend to look at this field in 2 different categories. One is a primary occurrence and the second is recurrence. And when someone has a recurrence, their microbiome has been injured to the point where they’re susceptible to future recurrences. But maybe I can ask Lisa on the regulatory side or the label side to comment on importance and then Terri can speak from the commercial side, too.
Lisa von Moltke: Yes. No. So as Eric said, we have based our desire to have the broad label on the fact that clinicians see this as a homogeneous disease once you get into the recurrent population, but it’s also based on the FDA’s own guidance. If you look at the FDA’s labeling guidance, they go into quite a bit of extensive detail on situations where pathophysiology is the same and risk benefit can be also then assumed to be the same as a reason for why they would deviate, if you will, from the exact details of how something was run in a trial. There was also a JAMA paper last spring actually reviewing the number of times that FDA does do that. And it is very — it’s fairly common. So we feel very confident given the fact that the community — the medical community already views this as a similar situation, whether you’re in first or current recurrence, whatever.
We know that’s what the pathophysiology is, and the agency has a history of looking at things with that lens. So I’ll turn it to…
Eric Shaff: Yes, Ted let’s get back to your question, which is do we think it will be important, and maybe Terri can comment on that.
Teresa Young: Absolutely. I mean, sure, the recurrent population, as Lisa said, is seen as a fairly homogenous population. And I think the person who summarized that best with Dr. Carl Crawford, in the investor event that I referenced in my prepared remarks back in December, where he described this fork in the road. So it’s clearly also important, having the broad label and being able to serve a broad population because as you look at the epidemiology of the disease, quite a few of our patients are considered in that first recurrence pool, right? So we’re very eager to finalize our label with the FDA and determine our path forward from there.
