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Guzzi62

11/11/25 6:20 AM

#506841 RE: Investor2014 #506831

Do you really think that they will ask Anavex about the "missing" confirmatory trial so late in the process?

Oh, yes Dr Missling now you are here can you please explain why bla bla bla!!

Nope, I doubt that very much.

Didn't Missling say that the OLE is acting conf. trial?

If they were not happy about that, they would have told Anavex a long time ago: don't bother applying before you have this conf. trial concluded, or at least up and running.

But we will never know what will be said at the meeting, it's very exciting for sure, I expect approval of some sort.
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imho

11/11/25 11:44 AM

#506936 RE: Investor2014 #506831

A very good question that better have a good answer.

I strongly suspect it will also be questioned why Anavex decided not to run a confirmatory RCT in parallel with exploring regulatory pathways (EMA MAA).

IMHO