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BRIEF-Kiadis Pharma updates on marketing authorization application process for ATIR101 in Europe
September 27, 2017 / 5:11 AM / a month ago

BRIEF-Kiadis Pharma updates on marketing authorization application process for ATIR101 in Europe

Sept 27 (Reuters) - KIADIS PHARMA NV

* KIADIS PHARMA PROVIDES UPDATE ON THE MARKETING AUTHORIZATION APPLICATION PROCESS FOR ATIR101™ IN EUROPE

* ‍COMPANY HAS RECEIVED AND REVIEWED DAY 120 LIST OF QUESTIONS FOR ATIR101™ FROM EMA COMMITTEE FOR ADVANCED THERAPIES​

* EXPECTS THAT IT WILL BE ABLE TO ADDRESS ALL QUESTIONS WITHIN SIX MONTHS RESPONSE TIME THAT HAS BEEN AGREED WITH EMA.​

* ON TRACK TO POTENTIALLY OBTAIN (CONDITIONAL) EMA APPROVAL FOR ATIR101 IN SECOND HALF OF 2018

* EMA APPROVAL FOR ATIR101 WOULD ALLOW A EUROPEAN LAUNCH IN 2019 Source text for Eikon: Further company coverage: (Gdynia Newsroom:)

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