Amicus Therapeutics Inc
* U.S. FDA confirms Amicus Therapeutics may submit new drug application for Migalastat for fabry disease
* NDA submission targeted for 4q17
* Additional phase 3 study previously requested by agency to assess gastrointestinal symptoms is no longer required prior to an nda submission
* Based on series of discussions with, written communication from FDA, agency informed it may now submit an NDA for Migalastat
* Says is preparing NDA submission under subpart H, which provides for accelerated approval Source text for Eikon: Further company coverage:
