Posted on IHUB by falconer66a,
Fletch
falconer66a
Re: xodcode post# 387203
Thursday, 12/01/2022 9:14:15 PM
Mayo Was There; I'm Home, Catching Up
Where are Mayo and falconer...They've had this right from the getgo!
Well, Mayo was at the event; heard and saw things firsthand. His reports will be wonderful. So glad he could be there.
Just as the presentation started, I enjoyed the fine evening meal my wife prepared. Wasn't able to log back on and see what happened until just a few minutes ago.
But, exactly as I anticipated, blarcamesine, as always in the past, in both murines and real humans, scored another big win; the biggest in its and Anavex's history. The preclinical and early clinical trials all predicted this fine result. Simply, blarcamesine works; always, by all of the ways I and others have described. On out anyone questioning the drug's mechanisms of action (MOAs) is either a fool or is profoundly ignorant.
Like the rest of the posters with scientific competence, I'm eager to scrutinize, understand, and perhaps comment on the clinical details when they become available. Eager to see if the 30mg and 50mg dosing arms can be distinctly separated in the data. Most likely, 50mg will be the preferred dose in further blarcamesine therapies for Alzheimer's.
Most here know this, but I'll lay it out again: In order for the FDA to approve a new drug several criteria must be considered. First, of course, adverse events, side effects, cannot be overly severe. Blarcamesine wins with that; not so common for drugs acting powerfully in the central nervous system.
Next, the candidate new drug's therapeutic outcomes must match or exceed any existing standard of care (SOC) drug for the targeted indication. If the SOC is Aricept, blarcamesine wins altogether. Same for any of the existing or proposed monoclonal antibodies, such as the Biogen drug.
The only remaining question I see is whether or not if the FDA will require another Phase 3 clinical trial, to adequately confirm all that this present study demonstrated. From my perspectives I think there is ample evidence of both safety and efficacy to allow a prompt, outright approval of the drug as a permitted Alzheimer's therapy. But others more familiar with the FDA will more precisely deliberate on that issue.
Next? Clinical trials results for both Rett syndrome and Parkinson's disease dementia. Just as with Alzheimer's, blarcamesine will prove safe and efficacious for both of those indications. After those, it will be trials of Anavex 3-71 for even more CNS debilities.
In the Anavex drug pipelines the valve on blarcamesine feeding into the Alzheimer's container is now open and flowing freely. In 2023, valves in the other pipeline streams will be opened. All along I've predicted that 2023 would be the year Anavex becomes a commercial success. So it will be.
https://investorshub.advfn.com/boards/read_ms...=170588664
Fletch
falconer66a
Re: xodcode post# 387203
Thursday, 12/01/2022 9:14:15 PM
Mayo Was There; I'm Home, Catching Up
Where are Mayo and falconer...They've had this right from the getgo!
Well, Mayo was at the event; heard and saw things firsthand. His reports will be wonderful. So glad he could be there.
Just as the presentation started, I enjoyed the fine evening meal my wife prepared. Wasn't able to log back on and see what happened until just a few minutes ago.
But, exactly as I anticipated, blarcamesine, as always in the past, in both murines and real humans, scored another big win; the biggest in its and Anavex's history. The preclinical and early clinical trials all predicted this fine result. Simply, blarcamesine works; always, by all of the ways I and others have described. On out anyone questioning the drug's mechanisms of action (MOAs) is either a fool or is profoundly ignorant.
Like the rest of the posters with scientific competence, I'm eager to scrutinize, understand, and perhaps comment on the clinical details when they become available. Eager to see if the 30mg and 50mg dosing arms can be distinctly separated in the data. Most likely, 50mg will be the preferred dose in further blarcamesine therapies for Alzheimer's.
Most here know this, but I'll lay it out again: In order for the FDA to approve a new drug several criteria must be considered. First, of course, adverse events, side effects, cannot be overly severe. Blarcamesine wins with that; not so common for drugs acting powerfully in the central nervous system.
Next, the candidate new drug's therapeutic outcomes must match or exceed any existing standard of care (SOC) drug for the targeted indication. If the SOC is Aricept, blarcamesine wins altogether. Same for any of the existing or proposed monoclonal antibodies, such as the Biogen drug.
The only remaining question I see is whether or not if the FDA will require another Phase 3 clinical trial, to adequately confirm all that this present study demonstrated. From my perspectives I think there is ample evidence of both safety and efficacy to allow a prompt, outright approval of the drug as a permitted Alzheimer's therapy. But others more familiar with the FDA will more precisely deliberate on that issue.
Next? Clinical trials results for both Rett syndrome and Parkinson's disease dementia. Just as with Alzheimer's, blarcamesine will prove safe and efficacious for both of those indications. After those, it will be trials of Anavex 3-71 for even more CNS debilities.
In the Anavex drug pipelines the valve on blarcamesine feeding into the Alzheimer's container is now open and flowing freely. In 2023, valves in the other pipeline streams will be opened. All along I've predicted that 2023 would be the year Anavex becomes a commercial success. So it will be.
https://investorshub.advfn.com/boards/read_ms...=170588664
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