Question-and-Answer Session
Operator
(Operator instructions) Our first question will come from the line of Brian Abrahams of Oppenheimer & Co.
Brian Abrahams – Oppenheimer & Co.
Hi, thanks very much for taking my question. Two pipeline questions for Hank. On GALNS, you talked a little bit about the Phase I/II endpoints you are looking at in that study. Can you talk about the endpoints that you are going to be exploring in the MorCAP registry, and how mechanically might you use that data to help you interpret the Phase I/II results and plan for a Phase III study?
Hank Fuchs
Sure, so I think one concept would be to understand the range of abnormalities from the MorCAP patient population. So for an example what is the relationship between age and impaired pulmonary function or age and impaired walk distance to better understand the relationships between keratin levels and impairments in either pulmonary function or walk test. And that might help us home in eligibility criteria or outcome measures in the Phase III clinical trial.
By looking at both the natural history setting, snapshot data together in the context of what we observe from the early treatment of patients in the Phase I/II study.
Brian Abrahams – Oppenheimer & Co.
Got you, and then on PEG-PAL, are there going to be any safety updates or any formal or informal interim analyses once patients receive more than one dose, given the safety questions?
Hank Fuchs
Well, as you know it is open label study. So we will be looking at the data from a safety perspective, you know fairly closely as to what we choose to announce and when we choose to announce I think we haven't settled on that yet.
Brian Abrahams – Oppenheimer & Co.
Okay, thanks for the questions.
J.J. Bienaime
Hi, Brian; it is J.J. (inaudible) on the phone, because I just read your recent report on the (inaudible) of Morquio, and I see there is a misunderstanding in terms of criteria, if I am not mistaken. I think that we saw that, we're excluding in the p2 the nonambulatory patients and that is not correct. Actually, the study does and will include nonambulatory patients, and the decision to do so and not to include them is – with intent is to access respiratory function in this older nonambulatory patient population, because MPS-6 patients, MPS-4 patients have substantial respiratory compromise. Part of this is due to fracture other than the skeleton probably including no storage and storage. We think the macrophage study is important in the lungs.
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