Thursday, March 02, 2023 11:39:29 AM
Quote: "That being the case, please explain how Anavex could declared having met all endpoints?
“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.”
Seems to me on that basis, it leaves investors and therefore the market suspicions and unsure, further emphasised by now 3 months later having no substantiating update and the original slide decks removed and replaced by an even less substantial 3 slides in the JPM presentation."
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That's a legitimate question...and frankly, I had to wrestle with it myself. Here's what I concluded:
The LPLV for the P2b/3 trial was in June...so everyone assumed that all of the CROs would've submitted their data within 30 - 60 days thereafter. In fact, Doc told us that it is common practice for the CROs to update and double-check their data while the trial was in progress...so there was no reason to believe that one of those CROs was having trouble.
Okay, fast forward to Monday, December 2nd...which was the week that CTAD was to start.
Missling has all of the results from the other CROs...those numbers have been crunched and everything looks great...so there's no reason for him to think that the last CRO is going to have anything different. In fact, Missling probably has his Press Release already written up.
But that last CRO still hasn't submitted his data!
Why? What the heck is the matter with him? Has s/he broken previous promises to release the data?
Missling has to be ticked off by now...so he tells the CRO to release his data immediately! The CRO gathers up all of the data and emails everything to Missling on Wednesday - the day before Anavex is to present their results for the P2b/3 trial.
Missling crunches everything together and presents the data...realizing afterwards that some this data needs to be researched further. And thus he removes all of the slide decks, hires Dr. Kun Jin from the FDA, and decides to create a video that will validate their success in achieving the primary and secondary endpoints.
That's how I see things from start to finish.
I could be wrong of course...this is just my interpretation of how things unfolded.
“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.”
Seems to me on that basis, it leaves investors and therefore the market suspicions and unsure, further emphasised by now 3 months later having no substantiating update and the original slide decks removed and replaced by an even less substantial 3 slides in the JPM presentation."
*****************************************************************************************************************
That's a legitimate question...and frankly, I had to wrestle with it myself. Here's what I concluded:
The LPLV for the P2b/3 trial was in June...so everyone assumed that all of the CROs would've submitted their data within 30 - 60 days thereafter. In fact, Doc told us that it is common practice for the CROs to update and double-check their data while the trial was in progress...so there was no reason to believe that one of those CROs was having trouble.
Okay, fast forward to Monday, December 2nd...which was the week that CTAD was to start.
Missling has all of the results from the other CROs...those numbers have been crunched and everything looks great...so there's no reason for him to think that the last CRO is going to have anything different. In fact, Missling probably has his Press Release already written up.
But that last CRO still hasn't submitted his data!
Why? What the heck is the matter with him? Has s/he broken previous promises to release the data?
Missling has to be ticked off by now...so he tells the CRO to release his data immediately! The CRO gathers up all of the data and emails everything to Missling on Wednesday - the day before Anavex is to present their results for the P2b/3 trial.
Missling crunches everything together and presents the data...realizing afterwards that some this data needs to be researched further. And thus he removes all of the slide decks, hires Dr. Kun Jin from the FDA, and decides to create a video that will validate their success in achieving the primary and secondary endpoints.
That's how I see things from start to finish.
I could be wrong of course...this is just my interpretation of how things unfolded.
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
