Question-and-Answer Session
Operator
(Operator instructions) We’ll go first to Geoff Meacham with JP Morgan.
Geoff Meacham – JP Morgan
Hi, guys. Thanks for taking the question. I have a couple of them. First on Fabry, I know we’ll have a little bit more detail on the design of the US and European studies, sounds like in a few months, but can you talk a little bit about how you potentially may have to reconcile results between these two studies if Europe is a head to head, and the US is (inaudible).
John Crowley
No, it’s a very good question, Geoff. We actually think it will set us up for a terrific development paradigm for the program. I’ll turn it over to Matt to answer the question specifically.
Matt Patterson
Hey, Geoff. I think reconcile, I guess – I mean, you’re welcome to give me a little more clarification there, but I think if I have you correctly, the real focus based on our feedbacks from FDA, is they’re very interested in a comparison to placebo, that that’s what’s going to get them to a license application and, of course, because it's accelerated approval based on the surrogate endpoint, they’re interested in working with us on a Phase 4 study that would validate that surrogate over a longer period of time. And the vision that we’d like to accomplish is to make that trial that I mentioned for Europe also meet the needs for the Phase 4 requirement for the US, so as far as that trial supporting US regulatory needs, it’s really more of a Phase 4 commitment that would be available post approval.
Geoff Meacham – JP Morgan
I got you. Okay, that makes a lot more sense. It doesn’t sound like you’re going to have to file with the European study.
Matt Patterson
No, not in the United States. I mean, just it would be common practice to give them everything that you have available that might be relevant, but their focus is absolutely on the placebo control trial and we’ve already initiated discussions around the Phase 4 vision. And as I said, the vision we have today is that European trial also meets our needs for Phase 4 obligation for the US.
Geoff Meacham – JP Morgan
And just as a follow-up, would you expect, just generally speaking – I know, again, you haven’t finalized design, but the size of both those studies to be roughly the same?
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