Matthew Klein: Thanks Paul for the questions. Let me grab the second one first, and then I’ll turn the other question over to our other Eric and Kylie. So first, in terms of the 518 data, so the 12-month data that we getting, Paul, that we would share in the first half of 2024, that will be data from the biomarker portion, right? We talked about PIVOT-HD as being a 12-month placebo-controlled study in two parts. The first part, the 12 weeks, focuses on pharmacodynamics and pharmacokinetics as well as safety. And then in that second portion, at the 12-month time point, we would have data, further data on neurofilament levels now less about safety, but maybe more about recording treatment benefits, CSF Huntington protein, mutant Huntington protein levels, volumetric changing on MRI.
We also will have some clinical data at that time point, which are not main endpoints at the 12 months, but obviously we’re collecting this data. I think — and we would certainly share the biomarker data, share what clinical data we have with the obvious caveat that even the 12 months, it’s very hard to have interpretable clinical effects on things like the UHDRS scale or even the total motor score for the different values that’s just given to the rate of progression in the disease and the sensitivity of those instruments to change over a short period of time. And so the answers will have those data. The main focus will be the biomarker data, obviously in terms of safety. We’ll also, when ready, have data on the additional subjects who are going to hit the 12-week time point and then ultimately hit the 12-month time point.
And we haven’t given a timeline to that, the timeline will be given. Obviously, the data point — most are interested in which is that 12-month data point for the initial cohort of subjects on whom we shared the 12-week data. So in terms of your question on Vamorolone and Emflaza, Eric, do you want to take that?
Eric Pauwels: Yeah. Thanks for the question, Paul. I think with Emflaza, we know that Emflaza has been currently on the market for more than six years. It is currently the standard-of-care. We’ve established Emflaza as the standard-of-care because there’s been a number of publications and there’s also a lot of scientific evidence that has actually preserved greater motor function than prednisone. And we know that the data has continually supported that. And we have very, very strong relationships with each one of the healthcare providers in terms of showing them the evidence, but also providing patient support. We understand that the community wants options, but we know that right now we have been focused on and our field force has been focused on not only growing the brand this year, but also we have a number of strategies that will also protect the brand following a loss of exclusivity, because we don’t necessarily see this as being a fall off, because of a generic or even a competitor.
And we have a number of key strategies right now. And a lot of them are centered around leveraging our patient support programs, because we have that direct line with patients and we have more patients on Emflaza than any other DMD treatment. We can continue to leverage that support. And through that process, we’ll continue to work with our specialty pharmacies. We’ll be targeting key relationships with payers to obviously continue to, if you will, foster brand loyalty. So all the more alone is an additional option. We also know that clinically it hasn’t been differentiated like Emflaza and that we have a very strong and loyal customer base.
Paul Choi: Okay. Thank you for taking our questions.
Operator: Thank you. One moment please. Our next question comes from the line of Tazeen Ahmad of Bank of America.
Tazeen Ahmad: Okay. Thanks so much for taking my questions A few quick ones from me, if I may. So to keep with the topic of the approval for Catalyst Pharma, how, if in any way, does that change your strategy for how you might want to look beyond the loss of exclusivity for Emflaza next year and beyond? And then second question, as it relates to sepiapterin milestone agreements with Censa, I believe you’ve already paid them $30 million for completing Phase 3 enrollment. I guess what other milestones should we anticipate either this year or next? And then lastly, to clarify on the conditional approval for Translarna, and I’m sorry if it was answered earlier, is there a set amount of time for which a conditional approval would need to be renewed on a go-forward basis? Thanks.
Matthew Klein: Thanks for the questions, Tazeen. Let me take the third one and then I’ll pass to the team for the other two. So the conditional authorization, obviously, there’s always comes with a specific obligation to collect additional data. So that’s less of a time based, specific time based element, but rather the time is necessary for that data collection effort. Obviously, there have been therapies that have had conditional authorization for many, many years, even beyond a decade. So for us, what we would do is look forward to the opportunity to keep the therapy on the market and then continue to collect the data necessary. We do also have the obligation to submit for annual renewals, which we’ve been through before.
That’s what we’ve done for the past several years to show that we’re, one, collecting the data that we’ve agreed to as part of a specific obligation, and then also providing any necessary updates, particularly around safety to the therapy that might emerge. Obviously, the safety story on Translarna is quite robust. And we’ve clearly been able to show that it is a therapy that is safe and long-term, just as we’ve been able to show the benefit long-term to the stride registry. In terms of your questions on Emflaza strategy and as well as milestone, Kylie, do you want to take Emflaza?
