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BRIEF-Amicus Therapeutics' ‍NDA submission for Migalastat targeted for 4Q17​
2017年7月11日 / 上午10点59分 / 1 个月前

BRIEF-Amicus Therapeutics' ‍NDA submission for Migalastat targeted for 4Q17​

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July 11 (Reuters) - 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:

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