Brief: Aegirbio Starts FDA Fast Track Process With Its COVID-19 Test

Subgen AI AB

24/11/2020 08:37

Nov 24 (Reuters) - Aegirbio AB  AEGIR.ST :
    * AEGIRBIO COMMENCES FDA FAST TRACK PROCESS WITH THE
COMPANY'S
COVID-19 TEST
    * HAS REVIEWED U.S. FOOD AND DRUG ADMINISTRATION'S (FDA)
REQUIREMENTS FOR MARKETING COVID-19 TESTS ON U.S. MARKET
    * IS NOW READY TO COMMENCE FDA AUTHORIZATION PROCESS
    * CO'S SYSTEMATIC EFFORT TO DOCUMENT ITS COVID-19 TESTS FOR
A
LAUNCH IN EUROPE UNDER CE-IVD DIRECTIVE IS THUS EXPANDED
    * REQUEST FOR EMERGENCY USE AUTHORIZATION (EUA) IS SUBMITTED
IN
UNITED STATES
    * HAS FURTHER DECIDED TO INVEST IN ADDITIONAL PRODUCTION
CAPACITY
    * EXPECTING TO REACH A PRODUCTION CAPACITY OF APPROXIMATELY
100,000 TESTS PER DAY AS EARLY AS Q1 2021

Source text for Eikon:  ID:nWkr4Wxml1 
Further company coverage:  AEGIR.ST 

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