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| Posts | 1803 |
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| Alias Born | 07/21/2013 |
Thursday, October 23, 2025 7:28:00 AM
I may be delusional but I think CHMP is very much on board.
I believe they see blarcasimine as a godsend and told Anavex a little promotion would be warranted, Hence the video.
To avoid the laughable misstep the FDA made they're giving us the full monty.
By that I mean the second clock stop so nobody can say they rushed it through despite a single smallish trial.
As a senior who wants a lake house (and many here are older than me) my pocketbook hopes for full approval, but there's a part of me that wants this to be the most studied drug in history. It's a paradigm shift in medicine.
It will of course start to be prescribed to people with mild to moderate and then to anyone who mentions forgetfulness to there doc (in time I think doctors will be trained to ask ) and then hopefully in time, just turning 50 gets you a script, all groups for the rest of their lives.
I think the larger paradigm shift began in 2014 when the first Hep C drug that cured was approved.
Ours is not a cure but we are following in it's footsteps, however the sticky wicket is, unlike Hep C, how do we know if it is working in the last two groups
Will low income people and others across the globe exercise strict adherence when there no obvious benefit ?
People forget quickly.
I laugh when I think back a few years ago when I washed our groceries because no one could tell us how covid spread.
I hated wearing masks but it seems a distant memory now.
When Alzheimer's goes from the sixth leading cause of death to the doble digits and many CNS diseases become rarer, will people question the necessity of a lifelong regimen?
Much different than a childhood vaccination shot.
I guess I'd like something hybrid, like full approval with a promised massive P4 trial involving our AI partner where prescribing doctors would simply check a box at each patients visit no matter the reason.
This would be extremely important considering ours was a smaller trial with 90+% being Caucasian.
I'd also like to see a large (eventually worldwide) prophylactic trial started quickly, perhaps with some government funding and public appeal for volunteers.
Caregivers, past and present, should be given a priority spot for obvious reasons.
I would also like to see some type of approval for PDD (I believe, if possible, we gave the EMA the PDD trial data to be used perhaps in lieu of a second AD trial and the Rett safety data).
I have no idea how off label prescribing works in Europe, but if possible I'd like any barriers removed in regard to prescribing blarcasimine for other dementias where nothing effective exists.
I believe they see blarcasimine as a godsend and told Anavex a little promotion would be warranted, Hence the video.
To avoid the laughable misstep the FDA made they're giving us the full monty.
By that I mean the second clock stop so nobody can say they rushed it through despite a single smallish trial.
As a senior who wants a lake house (and many here are older than me) my pocketbook hopes for full approval, but there's a part of me that wants this to be the most studied drug in history. It's a paradigm shift in medicine.
It will of course start to be prescribed to people with mild to moderate and then to anyone who mentions forgetfulness to there doc (in time I think doctors will be trained to ask ) and then hopefully in time, just turning 50 gets you a script, all groups for the rest of their lives.
I think the larger paradigm shift began in 2014 when the first Hep C drug that cured was approved.
Ours is not a cure but we are following in it's footsteps, however the sticky wicket is, unlike Hep C, how do we know if it is working in the last two groups
Will low income people and others across the globe exercise strict adherence when there no obvious benefit ?
People forget quickly.
I laugh when I think back a few years ago when I washed our groceries because no one could tell us how covid spread.
I hated wearing masks but it seems a distant memory now.
When Alzheimer's goes from the sixth leading cause of death to the doble digits and many CNS diseases become rarer, will people question the necessity of a lifelong regimen?
Much different than a childhood vaccination shot.
I guess I'd like something hybrid, like full approval with a promised massive P4 trial involving our AI partner where prescribing doctors would simply check a box at each patients visit no matter the reason.
This would be extremely important considering ours was a smaller trial with 90+% being Caucasian.
I'd also like to see a large (eventually worldwide) prophylactic trial started quickly, perhaps with some government funding and public appeal for volunteers.
Caregivers, past and present, should be given a priority spot for obvious reasons.
I would also like to see some type of approval for PDD (I believe, if possible, we gave the EMA the PDD trial data to be used perhaps in lieu of a second AD trial and the Rett safety data).
I have no idea how off label prescribing works in Europe, but if possible I'd like any barriers removed in regard to prescribing blarcasimine for other dementias where nothing effective exists.
Bullish
Recent AVXL News
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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
