Jun 09, 2021 / 09:30PM GMT
Salveen Jaswal Richter - Goldman Sachs Group, Inc., Research Division - VP
Good afternoon. I'm Salveen Richter, biotechnology analyst at Goldman Sachs, and we're really pleased today to have Amicus Therapeutics with us, for which John Crowley, CEO, is joining us. John, thank you for joining today.
John F. Crowley - Amicus Therapeutics, Inc. - Chairman & CEO
Yes. Hi, Salveen. Of course. Good evening, everybody.
Questions and Answers:
Salveen Jaswal Richter - Goldman Sachs Group, Inc., Research Division - VPMaybe to start here, maybe we'll start with the AT-GAA. You expect to complete the rolling BLA submission for the drug in Pompe disease in the second quarter. Given the results of the Phase III study with regard to what you saw at the primary endpoint and the secondary endpoint, what are the key factors contributing to your confidence in approval? And what are the key risks?
John F. Crowley - Amicus Therapeutics, Inc. - Chairman & CEO
Yes. Thanks, Salveen.