AETERNA ZENTARIS ANNOUNCES EMA DECISION TO ACCEPT A MODIFICATION TO AN AGREED PEDIATRIC INVESTIGATION PLAN FOR MACIMORELIN
Aeterna Zentaris Inc. (AEZS)
Last aeterna zentaris inc. earnings: 11/7 06:28 pm
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Source: GlobeNewswire
– Modifications recommended for some key elements of planned safety and efficacy Study P02 – – Modifications to the outline of Study P02 requested to ensure a harmonized global study protocol complying with requirements from EMA as well as FDA – CHARLESTON, S.C., April 07, 2020 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna Zentaris” or the “Company”), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced the decision of the European Medicines Agency (“EMA”) to accept a modification request by Aeterna Zentaris of the Company’s Pediatric Investigation Plan (“PIP”) for macimorelin as originally approved in March 2017 which covered the conduct of two pediatric studies and defined relevant key elements in the outline of these studies. The Company recently announced the positive results and successful completion of the first of these studies, Study P01. The goal of Study P01 was to establ
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