We’re obviously going to work as quickly as we can to accelerate those timelines. Obviously, we can’t shorten the 26 weeks, but we’re doing everything we can to shorten the time for data analysis, as well as getting the audited draft report, which is necessary for submission. So that’s where you get the 3Q time back from. It’s nearly the reality to do a 26-week study that takes more than 26 weeks. And we wanted to give an accurate depiction of what we think could be the longest possible date or the latest possible time for that submission. Obviously, as we mentioned, the vaccine received, we’re able to work out something with the agency where perhaps we could submit those data during the day 120 safety review and late stage review. And that’s going to be the basis of our ongoing conversations, because otherwise we believe we have a package that has every other component there.
And again, as the agency indicated in our discussions with them, they see our safety and efficacy data as being supportive of the NDA. And so we look forward to being able to submit them as soon as possible. In terms of comparability, this is simply a matter of not — we had very limited supply of the clinical material. So it was only a certain number of assay runs we were able to do to provide data to compare to the assays that were conducted in the commercial material. They wanted additional data points, a greater number of samples that we simply couldn’t provide, due to limited supply. In terms of the pre- BLA meeting, it was suggested that we hold the pre-BLA meeting. it was suggested that we hold the pre-BLA meeting, because they wanted to make sure that we’re aligned on the contents of the package, how we’re going to present their integrated safety summary from all the studies that are going on how we’re going to present the efficacy data, how are we going to include other components of the regulatory studies in the package.
They thought it would be very important to make sure as we told in the meeting, it’s not required, but we tell all companies, it’s important to have this. So we’re sure that the file leads the formats and specifications we want to avoid any filings. So we believe the most prudent thing to do is to have that pre-BLA meeting and then taking results, to be in a position to submit as quickly thereafter as possible.
Colin Bristow: Great. Thank you for that.
Operator: Thank you. One moment please. Our next question comes from the line of Jeff Hung of Morgan Stanley.
Jeff Hung: A question, in your discussions with the EMA on vatiquinone, what gives you confidence that it makes that move up day for conditional market authorization? Is there anything that you can update in terms of analysis or presentation that would increase your confidence for a positive outcome on the conditional marketing authorization given the feedback you’ve received from FDA? Thanks.
Matthew Klein: Yeah. Thanks Jeff, for the question. So the frameworks in FDA may slightly different, and the discussions we’re having with FDA are around the potential for accelerated approval based on upright stability being an intermediate clinical endpoint. Obviously, upright stability, we’ve talked about is all the four sections of the mFARS, which was the primary endpoint, the one that is shown to be most important in pediatric and in adult patients, particularly ambulatory patients because it’s been shown to be able to predict time loss of ambulation. Obviously, with future ataxia for ambulatory patients, the key thing for a therapy to do is to delay that time to loss of ambulation, loss of angulation and so you have an endpoint that can do it, we believe meets that criteria for an intermediate clinical endpoint.
We look forward to continuing the discussions with the AGC as is often necessary in real diseases. There’s a lot of back and forth to talk about the analysis we have. And as you indicated, could we provide some additional supportive analysis and MOVE-FA in particular the fact that we have a six-month open-label extension study during which all subjects are blinded so that gives us an opportunity to look at changes in trajectory, for example, for the placebo patients once we switched on taken. That’s the US. In terms of Europe, the conditional marketing authorization, there’s a number of criteria set out for conditional marketing authorization. Do you have initial data that shows that there’s a favorable benefit risk of a therapy? Are you meaning an unmet medical need getting — is getting this therapy to patients sooner potential public health benefit.
And I think when you consider vatiquinone and MOVE-FA study and the other data we have, we clearly meet all of those criteria. While we didn’t hit the primary endpoint of the overall at mFARS a number of important sources of benefit in the MOVE-FA study, not only in our pit stability, bulbar subscale, also on fatigue, which is an able symptoms for patients. And then if you look at the well-established safety profile in particularly in pediatric patients, we can clearly demonstrate that this initial study has a favorable benefit risk profile. Obviously, it’s unmet medical need, not only to pediatric patients, but there’s no approved therapies for FA in Europe for patients of any age and obviously, giving maybe other therapy that can potentially slow delay in loss of ambulation, has been irreversible morbidity and those patients who there from access to therapy sooner.
