So we certainly believe the market potential is larger, given the fact that we’re seeing adult neurologists treat patients than we did originally. Christy, maybe I’ll pass over to you for any additional thoughts.
Christina Shafer: Yes. Thanks, Scott. And Marc, thanks for the question. Scott makes really great points there. So again, just to kind of zero in on it, we really believe that this 2,000 addressable pediatric patients is very achievable, and our continued progress really underscores that with the fact that there are between 75 and 100 newborns a year, and we do not yet see that reflected in the ICD-10 codes. Now, we know that we need to continue to drive that message forward with the usage of the code. I think old habits are hard to break for some physicians, and then we just continue with that message. Another thing that continues to drive that number upward is not only our promotional efforts with genetic testing, but the AES also has a very, very large drive now to promote genetic testing not only in newborn patients, but — and maybe those who have a symptomatic diagnosis that don’t have a diagnosis yet from a genetic cause of their epilepsy.
So all of these things, not only what we’re doing but even in the epilepsy community, are driving larger diagnoses of patients which will help support not only just the 2,000 addressable pediatric patients, but then again, maybe some older patients as well.
Operator: Your next question comes from the line of Andrew Tsai of Jefferies.
Andrew Tsai: Appreciate all the updates. So maybe one more on the RSE. Obviously, the goal is to get to 82 patients by March of next year. So as we think about your enrollment cadence, how should we think about the holiday period in November, December time frame? Could enrollment slow down a little bit as people take time off or not necessarily? Or maybe said another way. Where would you ideally like to be on enrollment by year end 2023? And then finally, could we expect you — when could we expect you to give you the next update on enrollment?
Scott Braunstein: Let me start with the update, Andrew. I think we’ll continue to update people. Certainly at J.P. Morgan would be the most logical time or the J.P. Morgan Healthcare Conference, the most logical time to update enrollment. Typically, we’ve given a business update at that point in time. So we’ll continue to share the enrollment numbers with you folks. What we had talked about for us to hit these enrollment numbers was 4 to 5 patients a month. We felt very confident about that. With the current projections and our timing, we’re really expecting 3 to 4 patients a month to get to the finish line for us to get — and so we’ve tried to be as conservative as we could in terms of that thinking. At least my general view is that holidays, weekend doesn’t seem to have a big impact here.
I would say the last few weeks to months, we’ve probably enrolled 40%, 50% of our patients on Saturday and Sunday. My wife used to call them Saturday night specials when I was in practice. So I don’t think we’ve seen a major difference in cadence around holidays. Certainly, the weekends where you would think less staffing in the hospital would have an impact. So we’re generally thinking about these trends kind of having their good and bad weeks but are going to smooth out to 3 to 4 patients per month, and that’s going to get us to the finish line. And as I said, we’ll plan on that update. Joe, anything you want to add to that?
Joseph Hulihan: No. I actually just remembered, New Year’s Eve last year was a good time for enrollment. I don’t think — yes, this is different than a chronic outpatient study. And I don’t think that we’d expect the holidays to have the same kind of impact as it has on a study like that.
Operator: Your next question comes from the line of Douglas Tsao of H.C. Wainwright.
Douglas Tsao: I’m just curious in terms of the decision to discontinue the RESET trial and sort of obviously consider pursuing development in SRSE. Is that driven by sort of the feasibility or just the sort of simplicity of clinical — how it would fit in clinical practice, maybe it’s easier or just from a value proposition and pricing standpoint?
Scott Braunstein: Yes. Thanks for the question, Doug. Really appreciate it. I think there’s a lot of factors to play in here. I’ll let Christy comment from the commercial side. But I think overall, the message that — which I’ve always shared with investors is I always thought the ER opportunity would be a more complex one for us. We’d need a lot of sales reps. There are higher pressures in the emergency room from a pricing standpoint. But I thought it was important for us to do this study to really start to understand dosing in a frontline setting. That being said, as we’ve done this study, the costs have just really gone up dramatically as we have to obtain community consent, and there’s a huge upfront cost. And then we can spend money for community consent, and we may lose a site because they lose a coordinator or a physician moves territories.
And so I just looked at what we were spending — we all did — looked at what we were spending on the study, and I was quite worried it was going to just continue to grow, and we didn’t have a great commercial vision for this side of the business. The flip side is that we continue to get lots of requests for a super refractory status. We’ve shared that data a lot. We certainly think there is a regulatory path to expanding the label and getting to 63 grams of Captisol. And we think it’s a critically important and very meaningful business opportunity for us. And I think as we’ve sat down as a team and really strategized with our commercial team and our senior MSL teams, and we think about HEOR, health economic outcomes, we recognize that we’re going to have to do more in the space to really maintain our leadership and access to the drug.
So we really sat back as a team and said, we’ve got to spend our dollars wisely where we are today. It would be nice to continue the study. But given the cost of it, we think the dollars are going to be much more valuable, let’s say in a, call it a Phase IV 63 gram Captisol, 1,000 milligram of ganaxolone study in SRSE patients, one that physicians can understand dosing, we can align with the FDA. And obviously, we’ve seen a ton of interest given the number of patients that we’ve treated. So from a business standpoint, that’s the way we’re thinking about it. Christy, do you want to add anything on the commercial side?
