Wednesday, September 24, 2014 5:35:09 AM
"The NDA for Macrilen™ continues to be under review, with a PDUFA date of November 5".
• Continued discussions with the FDA and provided the agency with further information regarding the New Drug Application ("NDA") review for Macrilen™, which seeks approval as the first orally-administered drug for the evaluation of Adult Growth Hormone Deficiency ("AGHD"). Prescription Drug User Fee Act ("PDUFA") date set for November 5, 2014.
• Dennis Turpin, CFO of Aeterna Zentaris commented, "With our cash position, combined with the streamlining of our R&D activities, we are able to continue to advance our strategic programs and reach our near-term milestones related to Macrilen™ and zoptarelin doxorubicin."
Unless I'm missing someting.
http://www.sec.gov/Archives/edgar/data/1113423/000111342314000019/exhibit991pr-q2x2014.htm
Kei said:
NAVB October 17th
"Perfection is not attainable, but if we chase perfection we can catch
excellence." Vince Lombardi
Do your research! Play the TA. All posts are my opinion.
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