Replies to post #7137 on AEterna Zentaris Inc. (AEZS)

[TexasRambler]

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There is also the possibility we get immediate FDA approval...
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Not a snowball's chance in July, in Texas. FDA doesn't work that fast. Ever. If results were 100% cure it would still take about a year to get FDA approval. And the has never been a 100% cure rate for cancer. not even close.

[The_BORG]

No !!!
you forgot a lot of things

first, not even 1 company before got a approval on the first time from the FDA
second, when it's going on in our dreams, how high is than the pps in your mind ? 2 dollars or 20 dollars ?
you thinking one time on the market value ??? ;-)

i guess that until October we have got a free float from roundabout 1 billion shares +/-
it's for me impossible that the market value of AEZS is 2 billions and more

the RS will come
-for listening in the NASDAQ
-for kick out the penny gambler
-for a normal market value

AEZS will be the first company that don't do this out of similar historys

time will tell

[chmcnfunds]

No possibility of immediate FDA approval.

The company has stated there will only be stop/continue information-- no data. The Data and Safety Monitoring Board isn't even part of the FDA.

They only announced complete recruitment on June 30th, "Aeterna Zentaris Completes Patient Recruitment for ZoptEC Phase 3"

Here are the regs.

7.2. Accessing Interim Data As discussed above, accessing interim data by the sponsor carries many risks, not all of which may be fully appreciated by the sponsor. We recommend that sponsors contact FDA before initiating communication with the DMC regarding access to interim data Contains Nonbinding Recommendations 33 from a trial likely to be an important part of a regulatory submission. While FDA permission is not required, a discussion regarding the potential risks and implications of that action and of methods to limit the risks may contribute to informed decision making. 7.2.1. DMC Recommendations to Terminate the Study In almost all cases, a DMC is advisory to the sponsor; the sponsor decides whether to accept recommendations to discontinue a trial. FDA will rarely, if ever, tell a sponsor which decision to make. For trials that may be terminated early because a substantial benefit has been observed, however, consideration may still need to be given to the adequacy of data with regard to other issues such as safety, duration of benefit, outcomes in important subgroups and important secondary endpoints. We recommend that sponsors of trials that could potentially be terminated early for efficacy reasons discuss these issues with FDA prior to implementing the trial, when the statistical monitoring plan and early stopping boundaries are being developed. In these settings, consultation with FDA may provide the sponsor with important information regarding the regulatory and scientific implications of a decision and may lead to better decisions. Sponsors are encouraged to revisit these issues with FDA when considering DMC recommendations for early termination if new issues have arisen and/or if the regulatory implications of early termination were not adequately clarified at the outset of the trial. For trials that may be terminated because of safety concerns, timely communication with FDA is often required (see, e.g., 21 CFR 312.56(d) (drugs); 21 CFR 812.150 (devices)). In such cases, we recommend that the sponsor initiate discussion as soon as possible about the appropriate course of action, for the trial in question as well as any other use of the investigational product. We strongly recommend that sponsors initiate discussion with FDA prior to early termination of any trial implemented specifically to investigate a potential safety concern. 7.2.2. FDA Interaction with DMCs In rare cases, we may wish to interact with a DMC of an ongoing trial to ensure that specific issues of urgent concern to FDA are fully considered by the DMC or to address questions to the DMC regarding the consistency of the safety data in the ongoing trial to that in the earlier trials, to optimize regulatory decisionmaking. An example might be a situation in which FDA is considering a marketing application in which a safety issue is of some concern, and the sponsor has a second trial of the investigational agent ongoing. In such a situation, we might wish to be sure that the DMC for the ongoing trial is aware of the existing safety data contained in the application and is taking those data into consideration in evaluating the interim safety data from the ongoing trial. In such a case, we could request that the sponsor arrange for FDA to communicate with, or even Contains Nonbinding Recommendations 34 meet with, the DMC (see 21 CFR 312.41(a); 21 CFR 812.150(b)(10)), and care should be taken to minimize the possibility of jeopardizing the integrity of the ongoing trial. 7.3. DMC Recommendations for Protocol Changes A DMC may, in some instances, recommend changes to the study protocol, particularly in the context of their responsibilities for monitoring patient safety. Many protocol changes have little impact on the usefulness of a trial to gain regulatory approval. Certain types of changes to the protocol, however, such as changes in the primary endpoints, could have substantial impact on the validity of the trial and/or its ability to support the desired regulatory decision if they potentially could have been motivated by the interim data. We recommend that sponsors discuss proposed changes of the latter type with FDA before implementation.

http://www.fda.gov/OHRMS/DOCKETS/98fr/01d-0489-gdl0003.pdf

AEZS