Replies to post #15588 on AEterna Zentaris Inc. (AEZS)

[chmcnfunds]

My take (I have no shares) is that following the Phase III failure announced January 4th < http://ih.advfn.com/p.php?pid=nmona&article=73542894 > they requested a meeting to help determine whether they should initiate another trial. They have requested a Type A meeting:

Quote:
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These interactions are organized around three "types" of meetings:

Type A meetings, which are used to help "an otherwise stalled product development program proceed."
Type B meetings, which are routine meetings occurring at pre-defined endpoints between FDA and a sponsor. Meetings typically occur right after or right before the submission of clinical data or a new drug filing.
Type C meetings, which is a catch-all category for any meeting which falls outside of Types A or B.
New Guidance on How to Request and Conduct PDUFA Meetings
Under PDUFA—specifically PDUFA Reauthorization Performance Goals and Procedures—FDA is supposed to schedule these meetings within fairly strict timeframes to ensure that the development of a drug is not slowed down unnecessarily. When PDUFA was revised in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA), FDA was also tasked with tightening these deadlines further.

For example, Type A meetings should be scheduled within 30 days of FDA receiving a meeting request. Type B meetings should be scheduled within 60 days of FDA's receipt of the meeting request, "except in the most unusual circumstances."
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- See more at: http://www.raps.org/Regulatory-Focus/News/2015/03/10/21689/Meeting-With-FDA-Heres-What-Regulators-do-and-Dont-Want-from-Drug-Companies/#sthash.5uTBVJtA.dpuf

They are basing it on data which they already had and the news today does not indicate anything new and in my mind nothing newsworthy other than they intend to spend more funds based on hopes. The pop in pps today will soon be lost.

Also, they have a ATM going so they are probably selling shares today. Because it gapped up this AM, probably by AEZS, I'd assume most everyone who bought after the opening are losing. Long-term holders of course are ahead for the day.

Dan Ward who has been spot on re: AEZS tweeted:

Daniel Ward ?@danwardbio 3h3 hours ago
More
$AEZS wants you to know they havent given up on ~$50mil peak sales AGHD drug w CRL in '14. While waiting for ZoptEC, please bid for ATM shrs

AEZS

[Waxman]

The time line is approximately 30 days. Whether it will now be approved is still up in the air. But if the FDA felt Macrilen definitely isn't worthy of consideration this wouldn't be taking place. They wouldn't waste their time. But Macrilen came very close to passing FDA protocols the first time through. And after considering the companies data and the fact that Macrilen does seem to be a much safer test than the Insulin tolerance test. It is very possible it will pass.

The fact is there is a market for this product and it is a safer and easier test to administer. So who knows, especially with the fact that under Trumps new regime they want to ease FDA standards a little. Maybe it will all help to push this through.

That being said even if it does go through its not going to send this to the moon but this company needs to catch a break and start producing and earning and this could be a nice kick start.

I do own stock and I am not trying to pump it in any way, just what my DD tells me. I am very hopeful with what I heard in todays release. Way more than the company peddling its ware's at a few NY conferences this week.

Just my 2 cents