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Friday, July 19, 2019 2:02:04 AM
I think the gut microbiome just like the DNA analysis is interesting and should be done to learn even the trial base is small and open label.
In parallel we have well designed controlled trials in 3 indications running, 2 of which have been further extended. These trials will give the answer to the core question - does the drug work well enough that approval is proven more likely?
There is no obligation on Anavex to keep presenting data from the P2a extension and doing so will not change the design or influence the outcome of the current controlled trials.
I can see why some feels the company keeps cooking soup on the same old stone hoping that it might raise SP to dilute less and raise more more cash. At the same time Missling has the same insight as the rest of us, namely that ‘cooking more soup on the old stone’ by now seems sure to do the opposite.
Yes I have the same questions to this latest data and analysis as you do and it frustrates me too that Anavex do not put it in clearer context. However, what the KEM analysis finds is what it finds and it can be criticised in classic statistical terms, while still being useful insights that may well inform later registration trials.
In conclusion I believe Anavex is presenting the ongoing findings on mining the P2a trial extension in the interest of science and the Precision Medicine approach to see what can be learned in a set of CNS diseases that are screaming out for a new approach.
Meanwhile, all we have to do is wait about 6 months for controlled trial readouts to start rolling out.
During the next 6 to 12 months I doubt very much that the new shelf can or will be used to raise money - it simply doesn’t make logical or practical sense.
In parallel we have well designed controlled trials in 3 indications running, 2 of which have been further extended. These trials will give the answer to the core question - does the drug work well enough that approval is proven more likely?
There is no obligation on Anavex to keep presenting data from the P2a extension and doing so will not change the design or influence the outcome of the current controlled trials.
I can see why some feels the company keeps cooking soup on the same old stone hoping that it might raise SP to dilute less and raise more more cash. At the same time Missling has the same insight as the rest of us, namely that ‘cooking more soup on the old stone’ by now seems sure to do the opposite.
Yes I have the same questions to this latest data and analysis as you do and it frustrates me too that Anavex do not put it in clearer context. However, what the KEM analysis finds is what it finds and it can be criticised in classic statistical terms, while still being useful insights that may well inform later registration trials.
In conclusion I believe Anavex is presenting the ongoing findings on mining the P2a trial extension in the interest of science and the Precision Medicine approach to see what can be learned in a set of CNS diseases that are screaming out for a new approach.
Meanwhile, all we have to do is wait about 6 months for controlled trial readouts to start rolling out.
During the next 6 to 12 months I doubt very much that the new shelf can or will be used to raise money - it simply doesn’t make logical or practical sense.
Recent AVXL News
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- Form 8-K - Current report • Edgar (US Regulatory) • 03/25/2026 08:06:00 PM
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- 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
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- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/09/2026 09:40:27 PM
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- 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
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- 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
