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JeffKal

09/23/14 11:02 AM

#3476 RE: kei #3469

What is pduaf?

BooDog

09/24/14 5:35 AM

#3481 RE: kei #3469

PDUFA run up to November 5 release.
"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:

Saturday, September 20, 2014 11:22:58 AM
AEZS - only 32 trading days to PDUFA! this is in my view only, but, AEZS will get a lot of attention after september (after PGNX & PSDV this month) since not much is going on in the bio-land at all in octoberrrr...hence, i don't think the pps will go down to $1.25 area as you said.



NAVB October 17th :-)