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Amicus Therapeutics, inc (FOLD) Q2 2021 Earnings Call Transcript
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Amicus Therapeutics, inc (FOLD) Q2 2021 Earnings Call Transcript
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Operator
Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics First Quarter 2021 Financial Results Conference Call and Webcast. [Operator Instructions]
I would now like to turn the conference over to your host, Mr. Andrew Faughnan, Head of Investor Relations. You may begin.
Andrew Faughnan
Thank you, Mary.
Good morning. Thank you for joining our conference call to discuss Amicus Therapeutics first quarter 2021 financial results and corporate highlights.
Speaking on today s call, we have John Crowley, Chairman and Chief Executive Officer; Bradley Campbell, President and Chief Operating Officer; Daphne Quimi, Chief Financial Officer; and Dr. Jeff Castelli, Chief Development Officer. Joining for Q&A, we ll have Dr. Mitchell Goldman, Senior Vice President of Clinical Research joining.
Submissions to Seek Approval in both ERT Naïve and ERT Switch Pompe Patients
Completion of Rolling Biologics License Application On-Track by end of 2Q21
PHILADELPHIA, May 03, 2021 (GLOBE NEWSWIRE) Amicus Therapeutics (NASDAQ:FOLD) today announced the completion of a successful Type B Pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration (FDA) for AT-GAA (cipaglucosidase alfa co-administered with miglustat), its investigational two-component therapy for the treatment of Pompe disease. Based on this formal pre-BLA meeting and the final written communication received from the FDA, Amicus intends to complete the rolling BLA submission for cipaglucosidase alfa and submit a New Drug Application for miglustat.
Amicus Therapeutics Inc (FOLD) Q4 2020 Earnings Call Transcript Motley Fool Transcribers © The Motley Fool Logo of jester cap with thought bubble.
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Operator
Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics Fourth Quarter 2020 Fiscal Year Results Conference Call and Webcast. [Operator Instructions] I would now like to turn the conference over to your host, Mr. Andrew Faughnan, Head of Investor Relations. You may begin.
This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company s SEC filings. Please see our
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