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Catalyst

Slingshot members are tracking this event:

NDA filing of Migalastat HCI monotherapy (012) for Fabry Disease delayed following meeting with FDA. Expected to be filed in mid-2016

Source Link:: http://ir.amicusrx.com/releasedetail.cfm?ReleaseID=1001180

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Additional Information

Additional Relevant Details The Company anticipates meeting with the FDA in mid-2016 to present these data and discuss a potential pathway to submit a New Drug Application (NDA) for migalastat in the U.S.

http://ir.amicusrx.c...

Additional Relevant Details Update on July 11 2017: NDA Submission Targeted for 4Q17

http://ir.amicusrx.c...

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Catalyst Date

Occurred on:

Jun 05, 2017

Occurred Source:

http://ir.traconpharma.com/External.File?t=2&item=g7rqBLVLuv81UAmrh20Mp6+Usy2vof3+ko9cM9JVRFkMExPudAye4oSrPtGwmRHz95YFkuR8AXskAhOGkYD3AQ==&cb=636437624308922578

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Related Keywords Nda, Migalastat, Hci, Fabry Disease, Chmp