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mike_dotcom

02/19/25 12:28 PM

#483419 RE: k9uwa #483418

"Gee Mike we are back to slightly positive for today." Amazing! Maybe someday soon we'll outperform SAVA!
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boi568

02/19/25 12:48 PM

#483421 RE: k9uwa #483418

I am a bit contrarian on the regulatory significance of the first clock stop. At Day 120, Anavex is likely to receive a List of Questions, and the company will respond with its answers, concluding the clock stop. At that point, we don't really yet know whether the answers are going to satisfy the EMA or not. That's answered on Day 180 when the EMA could present us with a List of Outstanding Issues, i.e., items that are still unresolved by the answers to the first clock stop.

We should nonetheless have some clues as to how things are progressing. Was there a first clock stop? Was there a second clock stop? How long did it take Anavex to respond to the LoQ?

Despite the (low percentage) uncertainties inherent in the current process, I do expect the share price to rise during this period as the time for the EMA approval/disapproval recommendation draws closer and the likelihood of an approval looms over the market.
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Investor2014

02/19/25 12:50 PM

#483422 RE: k9uwa #483418

Not impossible.

Perhaps a little bit of an increase when the OLE results come out. Definitely when we have successfully past Clock Stop One. Starts April 25th and ends when Anavex has successfully answered all questions.


Aside from that happening, I don't see starting more trials helping the share price.

Potentially a rock solid readout of "A Study of ANAVEX3-71 in Adults With Schizophrenia (SZ-001)" could help, but I currently see that trial being where the P2a AD or P2 PDD trials where back when and not as far ahead as the Rett EXELLENCE trial was supposed to be.
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Hoskuld

02/19/25 1:24 PM

#483425 RE: k9uwa #483418

Spot on. Institutions are already, it seems, starting to pile in.

Is it customary for companies to PR their progressing past clock stop one?