Matthew Klein: Hey David it’s a good question. Obviously, we’ve talked a lot about all the different aspects in your question. Obviously, the importance of having a stable diet in the trial so that we don’t confound the trial results. It’s incredibly important that we have an understanding of the effects of sepiapterin relative to placebo in the context of stable diet. But we also know as you referred to that being able to liberalize diet is really the holy grail for PKU patients. Their diet is highly restrictive and it obviously takes an enormous impact on the patients and their families in many, many ways. And obviously, one of the key differentiating factors is our — is the ability of sepiapterin to maintain phenylalanine levels within control and still allow for liberalization of the diet.
We saw in the early Phe data — Phe tolerance data that we have presented thus far both in the first set of readout as well as in the PKU commercial deep dive a few weeks back that we’re seeing that signal of Phe tolerance in the face of Phe intake that exceeds RDA levels in many patients. And as we’re looking at the data that are continuing to come in from the open-label extension, we’re seeing that continue to be the case as more and more patients go through that protocol. And we look forward to sharing those data at the SSIEM and in future — and in forums in the future. And so what the label would say we’re not sure. It is likely since the protocol talked about stable diet that that will be in there. But nonetheless in all reality and everyday life patients will have possibly some component of diet control.
But obviously, what they do in daily life and ability to liberalized their diet is going to be much more impactful, not in how the drug is necessarily prescribed, but just in what the perceived value is. The increased physician uptake and patient interest is finally being able to have an oral tolerable therapy that not only provides that control, but finally allows them to liberalize their diet which is so very important to patients.
David Lebowitz: Got it. Thank you so much for taking my questions.
Operator: And thank you. And our next question comes from Eric Joseph from JPMorgan. Your line is now open.
Unidentified Analyst: Hi. Good afternoon. This is Hannah [ph] on for Eric. Thanks for taking the question. Just wondering when we might be able to see maybe a fuller update or presentation of data from the Phase III FA study. As you guys are considering and conducting additional analyses to take to the FDA just wondering if there’s a plan to present these to the Street?
Matthew Klein: Yeah, Hannah. Thank you very much for the question. So obviously, we prepare — we shared the key top line data from the study including the positive results and a number of the — a number of the secondary endpoints and the two important components of the mFARS, the bulbar subscale as well as the upright stability subscale. But obviously, we have done additional analyses particularly around being able to quantify the likely long-term benefit expected with regards to loss of ambulation based on the difference we were able to achieve in slowing progression on the upright stability scale. So we’re going to continue to do some more work in that area and we will look forward to showing those — sharing those analyses in the future either as part of a publication or a presentation that would be available to the investor community.
Unidentified Analyst: Okay. And then this may be a little bit more of a niche question. So for the diet liberalization study for PKU, just wondering from your conversations with physicians and patients, is there a specific amount or just percentage of increased Phe tolerance that patients might achieve that would be considered clinically meaningful to both physicians and patients?
