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Friday, October 31, 2025 8:55:38 AM
Be investors also regarding this crap. If I was short, which I am not, I could have written something accurate that would be far more scary than this crap.
And while I am at it, Biochecker's 'knowledge' comes from acquaintances of his who have actual friends that mix with the upper echelons of biotech investors or some similar statement I recall him posting years ago - not impressed with those posts either - they are just not scary enough if that was the intent.
EMA Rejection Imminent
Based on:
Anavex’s failure to use a pre-specified, validated endpoint
Lack of replicated efficacy across trials
Statistical red flags and post-hoc manipulations
…we believe the European Medicines Agency (EMA) will reject blarcamesine’s marketing application for Rett syndrome.
This would be catastrophic. Anavex has no commercial assets, no backup revenue stream, and is burning cash with no sales team or partner in place. A failed EMA verdict triggers an immediate repricing of the equity to reality.
We believe that moment is weeks away.
Alzheimer’s Trial — More of the Same
This isn’t an isolated Rett issue. Anavex’s Phase 2 Alzheimer’s trial followed the same script:
Switched from ADAS-Cog to MMSE post-hoc.
Relied on “SIGMAR1 genetic subgroup” cherry-picking to justify weak primary outcomes.
Avoided meaningful cognitive functional endpoints like CDR-SB or ADCS-ADL.
The longer we wait, the sooner we will get rich!
Recent AVXL News
- 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
- Anavex Life Sciences to Present Oral Blarcamesine Data at the 18th Clinical Trials on Alzheimer’s Disease (CTAD) Conference • GlobeNewswire Inc. • 11/26/2025 12:30:00 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 11/25/2025 09:31:44 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/25/2025 12:30:48 PM
- Anavex Life Sciences Reports Fiscal 2025 Fourth Quarter Financial Results and Provides Business Update • GlobeNewswire Inc. • 11/25/2025 12:30:00 PM
- Anavex Life Sciences to Present at the 44TH ANNUAL J.P. MORGAN Healthcare Conference • GlobeNewswire Inc. • 11/19/2025 12:30:00 PM
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