Aeterna Zentaris to pursue FDA registration of Macrilen

Tuesday, Feb 14, 2017

Aeterna Zentaris announces plans to pursue FDA registration of Macrilen(tm). FDA has agreed to consider company's conclusions during a type a meeting.  Co concluded that macrilen demonstrated performance supportive of achieving registration with U.S. Food and drug administration

Aeterna Zentaris says co-primary endpoint "negative agreement" with itt, which is considered as more relevant endpoint, was met. Says co-primary endpoint "positive agreement" with itt was not met.



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