InvestorsHub Logo
Followers 229
Posts 21458
Boards Moderated 2
Alias Born 08/03/2006

Re: kei post# 3469

Wednesday, 09/24/2014 5:35:09 AM

Wednesday, September 24, 2014 5:35:09 AM

Post# of 18784
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 smile

"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.

Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
Recent AEZS News