Question-and-Answer Session
Operator
(Operator instructions) We’ll take our first question from Matt Osborne with Lazard.
Matt Osborne – Lazard
Hi, guys. Thanks for taking the question. I have a few questions, if I could start with Matt perhaps. Have you reached an agreement with either of the agencies in the FDA and the EMEA with what would be an acceptable surrogate endpoints for Amigal?
Matt Patterson
Hey, Matt. No, we haven’t finalized the discussions with either of the FDA or the EMEA, so those continue to be ongoing. And as we mentioned during the call, we expect to be able to provide an update on where exactly we are on that process by the end of the year. And certainly, as we get to that update and then beyond, we’ll keep you totally informed but right now, it’s not complete and we’re on track to provide you an update by the end of the year.
Matt Osborne – Lazard
Is there any risk that either group could arrive at a different endpoint? Or do you feel, based on the discussions and comments that you’ve received from both, that they’re moving in the same direction?
Matt Patterson
I think it’s difficult for me to speak to specifics of those ongoing discussions. I mean, they’re both ongoing now. We are very upbeat about the progress with both. Sure, I mean, it takes some time to get through the process of working with both authorities but we want to get, as we said before, we want to get the perspective from both regions, so we designed the most robust Phase 3 program for global approval and successful marketing of the drug. So we’re all going to do our very best to tie it all together and come up with a plan that makes the most sense for this program.
Matt Osborne – Lazard
Great. Then update 23 of those patients in extension study. Have you started to see what the dose optimization? Are you seeing continued stabilization or are these patients starting to improve?
Matt Patterson
I don’t have a data update for you at this time, Matt, but we’ll give you an update in Q1 as projected earlier; but we are collecting ongoing safety and efficacy data, which does include the clinical measures of disease that we’ve spoken about before, and so we’ll be happy to report on those over time. The focus for the Q1 update will be around those potentially optimized regimens, which means focus on both the safety but also enzyme levels and GL-3 levels, so I think that’s a reasonable expectation for Q1.
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