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Amicus Therapeutics' CEO Discusses Second Quarter Results - Earnings Call Transcript

So if I can draw your attention now to Slide 4, I'll just provide a couple of updates on Q2 highlights including the very recent development that you've seen in the press release that we sent out just about an hour ago based on a very recent and very positive type-C meeting interaction with the FDA which we think is going to bode very well for this program, so we'll provide some more update and color on that.

But just generally with our Phase 3 Program, we're happy to report that in the second quarter, we completed the six month primary treatment arm and again remember that the study 011, our Phase 3 study for US approval, it's a randomized placebo-controlled study again with a six-month double-blind primary treatment period and then if you'll recall, a six-month open label follow-up period.

We are updating our patient disposition today letting everybody know that at the end of that six-month primary treatment arm, we had 63 of the 67 patients completed. We did have four dropouts, none due to any FAEs or any concerns with the drug. They came off for various other reasons as we expected.

There was a lower than expected dropout rate for this study so we think another point that would further enhance our likelihood of success here. So we end the study with 63 patients. Of those 63 who completed the primary treatment arm, we had a 100% conversion of those patients to voluntarily elect to continue on the study.

So again, half the patients having been randomized to migalastat, half randomized to placebo, patients blinded of course to either. At six months, those patients who had been on migalastat continuing on migalastat. Those patients who had been on placebo continuing onto – coming onto migalastat again blinded to that.

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