Amicus Therapeutics Inc Q2 2022 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Eliana Rachel Merle - UBS Investment Bank, Research Division - Analyst : Just a follow-up on the U.S. manufacturing inspection. I guess when typically in the review cycle would you expect the inspection to occur by? And I guess how long ahead of the October 29, PDUFA, where it needs to be scheduled by for you to be confident that it could be completed ahead of the PDUFA? I guess, just in terms of like the scheduling and how long it would take on schedule? Just any color that you could give on that. And then just a quick one on Galafold. You mentioned that in June, you saw the highest number of net new patients in the U.S. on Galafold. Is this something that you expect just around seasonality? Or is this sort of a broader trend that you expect to continue?

Question: Zhiqiang Shu - Joh. Berenberg, Gossler & Co. KG, Research Division - Analyst : Congrats on the progress as well. I want to ask about the -- in your Slide 16, you talked about ongoing support of studies on LOPD and IOPD. Maybe can you talk about the implications there and how that relates to your label discussion? And secondly, just looking at Galafold sales in the first half and full year guidance, considering the negative impact from foreign exchange, it looks like the second half, they will be pretty flat concerning the foreign strange. Maybe provide a bit of color on that?