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Steady_T

03/29/24 2:21 AM

#455308 RE: boi568 #455306

I agree with your post. I would suggest one small change. It is not that an NDA or MAA can be filed but rather that one is approved.
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Investor2014

03/29/24 5:49 AM

#455313 RE: boi568 #455306

Let me first remind you of the post I originally replied to.

The FDA's current release gives that class action a snowball's chance in hell.


An incorrect statement, which I corrected as follows:

The FDA thing will have no influence on the trial [or "litigation"/"case"] one way or another for the simple reason that it is an event that falls outside the class period.


I assume from your below sentence that when you now use "trial" you meant litigation and concede to my original post.

The merits of the trial results aren't affected, of course, by a change to FDA guidance.


Then in light of the new FDA guidance, mentioned in the original post I replied to, you go on to discuss the chances of FDA approval from the P2b/3 trial in light of that new guidance. While interesting, a non sequitur to the discussion about the securities class action complaint filed against Anavex.

In conclusion the new FDA guidance may perhaps help the chances of FDA approval from the P2b/3 and it will NOT have any influence on the merits of the current securities class action case against Christopher Missling / Anavex.

Besides all this of course the complaint filed against Anavex relates to the Rett (NOT AD) trials and the alleged "violated Section 10(b) of the 1934 Act by failing to disclose pertinent information relevant to the Company or, alternatively, providing information about the Company which was misleading or deceptive."