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abew4me

03/01/23 9:27 PM

#405454 RE: Joseph_K #405440

Quote: "Significantly, the provided data does not state how many in the drug arm and how many in the placebo arm had a score change of +3.5 points or better (Investor refers to these numbers as n); that's a weird omission and makes it impossible to determine the significance of the touted Odds Ratio."

We know that Anavex didn't get all of the trial results from one of their CROs until the day before the CTAD conference...which made it extremely hard for them to add up everything.

It's my contention that they (Anavex) is having to reevaluate the CROs results. That's why the provided data is missing some of the statistics you mentioned above. IR made a comment recently that and I quote: "The numbers are even better than we thought. The more we analyze the data the better it gets." (I'm paraphrasing)

That quote was made by another MB who spoke with IR and posted it here...so take that for what it's worth. I think it makes perfect sense if they are having to reevaluate the data from the last CRO and combine the numbers all over again.

Additionally, another MB posted the following a few weeks ago:

hnbadger
Friday, February 17, 2023
Post# of 404558

This is from AVXL IR:
The company is working on another
video and an upcoming press release
that will address many of the
questions that you asked. Moreover,
some of the answers will elaborate
on specifics, all of which we believe
will provide a thorough
understanding of our initiatives.
At
this time some of your questions can
not be answered today, because new,
updated data will be available to us
in the near future,
all of which we
would need to disseminate such
information in accordance with
Regulation FD - via press releases
and/or 8k filing, not through an
individual email or one-on-one
conversation.
Thanks 100fold from ST

Again, this makes perfect sense to me if they are having to reevaluate the data from the last CRO. Of course, I don't want to take away from the number crunching that is a result from the AI either. But I think the most obvious (elephant in the room) is the fact that the last CRO dumped his data the day before the CTAD conference...forcing Anavex to crunch his numbers in an extraordinarily short time.

But Anavex is obviously confident that everything is still intact because they continue to advertise the following CTAD results on their website:

ANAVEX®2-73 (blarcamesine) Meets Co-Primary and Key Secondary Endpoints for Patients with Early Alzheimer’s Disease

• ANAVEX 2-73 (blarcamesine) treatment slowed decline of cognition and function in patients with early Alzheimer’s disease over 48 weeks
• Patients treated with ANAVEX®2-73 (blarcamesine) were 84% more likely to improve cognitively compared to placebo, by ADAS-Cog score threshold change of -0.5 points or better [Odds Ratio = 1.84 (p = 0.015)]
• At clinically significant levels of improvement in function (ADCS-ADL score threshold change of +3.5 points or better), ANAVEX®2-73 (blarcamesine) treatment was 167% more likely to improve function compared to placebo [Odds Ratio = 2.67 (p = 0.0255)]
• Compared to placebo, ANAVEX 2-73 (blarcamesine) reduced clinical decline of
cognition and function by 27% with mean score difference of -0.42 points (p=0.040) as measured by the CDR-SB
• ANAVEX 2-73 (blarcamesine) was generally safe and well tolerated


All comments are just my opinion and should not be used to buy or sell AVXL shares. Do your own DD.