Josh Cohen: Yes. So I’ll say, ultimately, we can never expect or speak for the regulators. But certainly, our intention is with positive PHOENIX results, especially coming out of the top-line readout, we will want to push forward towards approval as quickly as we possibly can.
Justin Klee: Yes. And just adding, I mean, I think further to your questions, too, I think we remain confident in the design and execution of the study. Again, it’s a 664 participant study, our team is executing. And I think that those results will be a major milestone for the ALS community, the opportunity to have two positive studies in a disease where there’s been so much historical clinical trial failure, I think it’s hard to overstate what a big deal that will be for the community.
Geoff Meacham: Thanks guys.
Operator: Thank you. And the next question comes from Umer Raffat with Evercore ISI.
Umer Raffat: Hi guys, thanks for taking my question. I have two. Let me start with this perhaps. If I just look at the fact pattern on how you implemented the data restriction on IMS and Symphony vendors this summer and how that coincided with this massive slowdown, it just really puzzles me because I feel like not only was the Street ready from communication on your end, but also I feel like you limited the channels to which Street could have been ready for today. How do you — can you expand on that? Because it looks like you may have had a sense for discontinuations really picking up around July timeframe.
Josh Cohen: Well, Umer, maybe I’ll start. So our intention at launch was always to have the limited distribution model. And so we updated everyone in February that we thought we had identified one of the areas where there is some data coming out, and so we had addressed that. So that was back in February. And I think the most important thing here, though, is that we have huge long-term growth opportunities ahead of us. We’re very proud that we’re helping 3,900 people as of the end of the quarter. But again, I’ll reiterate, there are 30,000 people with ALS at any one time. And the last thing I’ll say, too, is that we’re really trying to transform the disease space here. As I said in my remarks, ALS historically is focused on symptom management, and we’re trying to shift the field to focus on meaningful interventions, that’s not going to happen overnight, but we think we’ve done a great job so far, but we’ve also identified even further opportunities to start to transform the landscape.
So we think we have great growth opportunities ahead of us.
Umer Raffat: Got it. And let me just follow-up. Just on, A, am I right in calculating about 5,500 patients may have started therapy since your launch? And secondly, if I model out on discontinuations, what I feel is it’s not just the discontinuation. It’s also the new starts might have dropped about 35%, 40% quarter-over-quarter from 2Q to 3Q. Is that right? Because I feel like you may have had about, I don’t know, 750 discontinuations in 3Q. But if that’s the case, you might be in for another about 650 to 700 discontinuations in 4Q, which makes it very hard to again put up a very meaningful net add number in 4Q unless your new add picks up very meaningfully versus where it was in 3Q. Am I on the right track there?
Josh Cohen: Maybe we haven’t commented on any of those metrics, but maybe just to circle back. There are roughly 30,000 people living with ALS in the United States. We have 3,900 on therapy. So we certainly see an opportunity to continue to grow. And that’s what we’re going to be out here trying to do. I think we shared several of the tactics that we think will achieve that.
Justin Klee: Yes. And I think that our initiatives are designed at again, transforming ALS. We have initiatives to help in the top centers where we think there’s further opportunity in the market, we found that there are far more people in the broader neurology community. And so we think there’s great initiatives we can do for further awareness. And as we showed in Canada, we think that we can use our strategies to show that staying on therapy longer matters. And again, that’s part of transforming the disease space. So in answer to your question on sort of both growth in terms of new people coming on as well as staying on treatment, we think we have great strategies to address all of those.
James Frates: Yes. Let me just take number two. I think as you do your calculations, actually, Margaret mentioned in her remarks, we’ve had actually steady new prescriptions from Q2 into Q3. So while we obviously want to see more growth and accelerated growth in that and we touched a little bit about that in our remarks. There’s no real distinctive change in terms of the new adds. Certainly, it slowed down from Q4 and into Q1, and we talked about that on the last call, but we’ve seen steady new adds. And just another point on the discontinuations, it’s not like we’ve seen a major drop off here. This has been a slightly steady decline as we move through time. We’ve always cautioned about what the right discontinuation model is, right, because we can’t model six months or nine months discontinuations until we get there.
So we’ve been tracking the CENTAUR data through last quarter. It’s gotten a little higher than that discontinuation rate over the last couple of months. That’s different in Canada. So we actually think that as we lean into this a little bit more and adjust our tactics here on what has been a very solid launch so far in our first nine months. This is an adjustment of tactics, and I think we can hopefully get back to seeing growth again.
Operator: Thank you. And the next question comes from Marc Goodman with Leerink Partners.
Marc Goodman: Yes, maybe you can give us a flavor for how October went to give everybody a sense of trends versus what we just talked about?
Josh Cohen: Yes. We usually don’t report month-to-month. But what I’d say is that we’re certainly rolling out many of the things that Margaret described. And certainly, there’s nothing revolutionary there in terms of things are continuing. We’re continuing to see net adds at a steady pace.
Justin Klee: Yes. I think just reiterating what Margaret and Jim were saying, the slowdown in net patient adds we saw was primarily driven by discontinuation. And we think we have great things to address there and as well as new opportunities for growth as well.
Marc Goodman: So just to be clear on the new patient adds, from second quarter into third quarter, you had a steady increase in new patient adds. And so whatever that steady pace was month-to-month, is that what it was? October, everything is just kind of the same, similar, slowing down, speeding up? Just give us a sense.
James Frates: Yes. I’d say steady is steady. And so I think that what we want to see is a reacceleration of that growth, right, back to the levels that we saw when we were first launching the drug. And I think a very important point to make here is that we’re doing exceptionally well in the key centers. And one of the things that we’re doing, right, and it was a logical place for us to focus, we’re going to keep that focus on those key centers where we’ve got penetration up to roughly 25% of all patients, as Margaret talked about. But what we have to do now is continue to grow there, but expand into the next deciles down. Deciles, say, 336 is where we’re going to be focused.
