Wednesday, March 01, 2023 9:27:35 PM
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.
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.
Recent AVXL News
- Anavex Life Sciences Highlights New Scientific Findings on Shared Biology Between Autism and Alzheimer’s Disease • GlobeNewswire Inc. • 04/14/2026 11:30:00 AM
- Anavex Life Sciences to Present at the 25th Annual Needham Virtual Healthcare Conference • GlobeNewswire Inc. • 04/07/2026 11:30:00 AM
- Anavex withdraws EU approval filing for Alzheimer’s therapy • IH Market News • 03/30/2026 12:39:26 PM
- Anavex Life Sciences Provides Comprehensive Regulatory Update • GlobeNewswire Inc. • 03/30/2026 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/25/2026 08:06:00 PM
- Anavex withdraws EU marketing application for Alzheimer’s therapy blarcamesine • IH Market News • 03/25/2026 02:06:58 PM
- Anavex Life Sciences Provides Update on Regulatory Review in the EU for Blarcamesine to Treat Early Alzheimer’s Disease • GlobeNewswire Inc. • 03/25/2026 11:30:00 AM
- Anavex Life Sciences Presents New Data from its AD-004 Phase IIb/III Trial at AD/PD 2026 Conference Demonstrating Consistent Correlation Between the Treatment Effect of Oral Blarcamesine and Preservation of Brain Volume in Early Alzheimer’s Disease • GlobeNewswire Inc. • 03/23/2026 11:30:00 AM
- New Scientific Findings Highlight Hypothesis of Autophagy Failure as a Precursor of Amyloid Beta and Tau Pathology in Alzheimer’s Disease • GlobeNewswire Inc. • 03/20/2026 11:30:00 AM
- Anavex Life Sciences Presents Significant Treatment Effects of Blarcamesine in New Advanced Alpha-Synuclein Model of Parkinson’s Disease at AD/PD 2026 Conference • GlobeNewswire Inc. • 03/17/2026 11:30:00 AM
- Anavex Life Sciences to Present at the Citizens Life Sciences Conference • GlobeNewswire Inc. • 03/03/2026 12:30:00 PM
- Anavex Life Sciences to Present at the 46th TD Cowen Annual Health Care Conference • GlobeNewswire Inc. • 02/25/2026 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/25/2026 11:07:01 AM
- Anavex Life Sciences Appoints Seasoned Healthcare Leader to Board of Directors • GlobeNewswire Inc. • 02/23/2026 12:30:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/09/2026 09:40:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/09/2026 12:31:17 PM
- Anavex Life Sciences Reports Fiscal 2026 First Quarter Financial Results and Provides Business Update • GlobeNewswire Inc. • 02/09/2026 12:30:00 PM
- Anavex Life Sciences to Announce Fiscal 2026 First Quarter Financial Results on Monday, February 9, 2026 • GlobeNewswire Inc. • 02/03/2026 12:30:00 PM
- Anavex Joins ACCESS-AD, a Major Initiative Funded by the European Commission, Through the Clinical Evaluation of Blarcamesine as Part of a Precision Medicine Approach in Alzheimer’s Disease • GlobeNewswire Inc. • 01/13/2026 12:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/09/2026 10:26:26 PM
- Edelson Lechtzin LLP Announces an Investigation of Anavex Life Sciences Corp. (NASDAQ: AVXL) and Encourages Investors with Substantial Losses Contact the Firm • PR Newswire (US) • 01/09/2026 01:13:00 AM
- Anavex Life Sciences Appoints Senior Vice President Global Head of Neurology • GlobeNewswire Inc. • 01/08/2026 12:30:00 PM
- Anavex Life Sciences Receives FDA Feedback on Alzheimer’s Disease Program • GlobeNewswire Inc. • 01/06/2026 12:30:00 PM
- Anavex Life Sciences Submitted Request for EMA to Re-Examine Its Opinion • GlobeNewswire Inc. • 12/18/2025 12:30:00 PM
- Anavex Life Sciences Provides Update on Regulatory Review in the EU for Blarcamesine to Treat Early Alzheimer’s Disease • GlobeNewswire Inc. • 12/12/2025 09:05:00 PM
