NEWS

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.

 

Source: reuters.com

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