Matthew Klein: FA, yes. So as we said we requested that Type C meeting from the FDA and it was granted and that will take place in the fourth quarter. And as we talked about while we didn’t hit the primary endpoint we had very strong data on a number of important aspects of the disease in particular the upright stability subscale. When you think about Friedreich ataxia as a disease and drug development in Friedreich ataxia, one of the main goals of any therapy would be to slow the time for patients to lose ambulation. That is one of the keys if not the key morbid transition point of the disease and any drug that targets altering the progression of the disease seeks to try to slow that time to loss of ambulation. The upright stability subscale of the mFARS has been shown to be a key predictor of time to loss of ambulation.
So the fact that, one we had pre-specified that particular subscale as an endpoint and two the fact that it is a component of the primary endpoint and showed strong signal of effect with a difference of about 1.3 points between treatment and placebo. And we’ve done some work to show that, that should translate to a delay in loss of ambulation of at least eight months and perhaps more with some other analyses that we’ve been able to do. So we’re able to come to FDA and be able to talk about the potential path to an accelerated approval where we’ve been able to demonstrate on an intermediate clinical endpoint upright stability that we’re able to delay — likely delay a longer-term significant morbid transition point of the disease loss of ambulation.
And the fact that, we showed statistical significance and a strong magnitude of effect we can demonstrate that we are able to likely provide a long-term clinical benefit with regards to really the key goal of FA therapy which is delaying loss of ambulation. So we look forward to having that discussion with the agency. Obviously with the Skyclarys approval that’s directed towards adult patients we have a study that was included primarily pediatric patients a very strong safety record of vatiquinone in pediatric patients. And then again now a data set that has many positive aspects but in particular very strong data with regard to ability to slow the loss of ambulation which is really the key goal of FA.
Kelly Shi: Very helpful. Thank you.
Operator: Thank you. And one moment for our next question. And our next question comes from Sami Corwin from William and Blair. Your line is now open.
Sami Corwin: Hi, guys. Thanks for taking my question. I guess, first do you have any clarity as to why the CHMP opinion for Translarna got pushed? I thought that was originally supposed to happen in May. And is there any contingency plan there if it doesn’t get approved? And then I have a follow-up question.
Matthew Klein: Hi, Sami thanks for the question. Actually the initial timing was end of H1. That timeline was put together based on how we thought the typical back and forth at 1C during the CHMP process such as a type two variation. Obviously, there is one more turn of questions back and forth and that pushed the H1 into the third quarter. So, we remain highly confident of our ability to achieve the conversion from conditional marketing authorization to standard marketing authorization knowing that really the bar here is being able to as the European statute states confirm the benefit that existed at the time of registration which of course was in 2014 based on our first placebo-controlled study 7. And now we have a data set in over 700 voys that not only confirms that benefit but actually expands it.
The variability that’s shown in Study 41 a statistically significant benefit on the all-comer ITT population which is the indicated population as well as showing significance on a number of different endpoints including North Star Ambulatory Assessment and timed function test. So this is really a body of data that not only confirms the evidence which is the charge, but builds on it.
