Kylie O’Keefe: Absolutely. Yes. So the royalty rates from Roche for every year are tiered between 8% to 16%. So that is on an annualized basis. So every year they start at the beginning with the 8% and they’re tiered up to 16%. So from that perspective throughout the year they progress through the different tiers. We’re up towards as we’ve seen with CHF 701 million of sales in the first half of the year we’re tiering up towards the second and almost near the third tier of royalty rates. So I wouldn’t say that they’re going down. If anything they go up. But that’s, on an annualized basis.
Michael Riad: Thanks for the clarification. Thanks so much.
Operator: Thank you. And for our next question we have Brian Abrahams from RBC Capital Markets. Your line is now open.
Unidentified Analyst: Hi. This is Joe on for Brian. Thank you for taking our question. Just going back to Translarna, can you talk about some of the potential outcomes of the CHMP opinion? Is there a possibility that Translarna can remain on the market with conditional authorization with the annual renewal? And I have a follow-up.
Matthew Klein: Yeah. Joe. Thanks for the question. So obviously the type two variations that we’re submitting, is to convert the conditional authorization to standard authorization. And as we’ve talked about we’re confident in the ability to do that given the strength of the data and our ability to meet the requirements of confirming. And I said earlier, building on the data that already existed at the time of registration. Obviously, if the CHMP were to decide that they want us to continue to collect data, whether that’s as part of the longer-term, open-label section of 741 which was included in the 72-week placebo-controlled, portion of the 72-week open-label portion obviously the analysis we presented and the analysis that formed the basis of the conversion request on the placebo control portion that’s a possibility.
Could the CHMP say STRIDE’s really great. It for the first time provides direct measurements of the long-term benefits of a therapy for DMD and also is able to capture the fact that we’re having an impact on the two key morbid transition points of the disease — loss of ambulation loss of pulmonary function and they say, we want more real-world data to convert that’s totally possible. So there absolutely is that possibility that they say continue with the conditional authorization for now which of course would mean business as usual for Translarna.
Unidentified Analyst: Got it. Thank you. That was very helpful. And also to touch on the US pathway, I guess if I’m not mistaken, Type C meeting has been requested this month. Is there a typical response time from the FDA to get back to you once the meeting has been requested? And also how much additional back and forth can you expect to have before the meeting is scheduled? Thank you.
Matthew Klein: Yeah. Thanks Joe. And we had said, so that meeting request came based on a recent discussion with the division. Within our division where we talked about the potential pathways to an NDA resubmission in the US, particularly now given the volume of data we have not only from the three placebo-controlled studies, Study 7, Study 20 and Study 41. But importantly those STRIDE data that I recently mentioned, which provide very strong evidence of the benefits that we’ve been recording over the course of the time of the clinical trials are translating to long-term meaningful benefit, in the most significant way possible that’s long time to loss of ambulation and loss of pulmonary function. The agency said, well, why don’t, we get all of our data together, including some of the mechanistic data that we generated over the years any analysis we want.
