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Steady T
A favorite , what's next for this?
RWD-RWE ...reveals more than FDA STAT SPEAK...IMO
Is this all legitimate or some kind of rip-off?
https://www.pharmaceutical-technology.com/data-insights/blarcamesine-hydrochloride-anavex-life-sciences-infantile-spasm-west-syndrome-likelihood-of-approval/
Thanks for posting this new information. Most of us can only imagine what it is like to have a close family member impacted by PDD. It is a tough-tough diagnosis to live with. Any positive news (like this) presents a glimmer of hope and relief. An Irish expression comes to mind..."All the Best".
Hoskuld
9.91+0.53 (+5.65%)
At close: 04:00PM EST
9.91 0.00 (0.00%)
After hours: 04:01PM EST...
WELL DONE. NOW, Lets finish this and move on to the next phase.
Hey Xena....stick around for a while....kick some axx. BR
Merry Christmas and happiest holidays to all from the rocky coast of Maine , especially to our AVXL WW staff and all AVXL CNS WW patients and families ... Just hang in there..."Help is on the Way"...
Auf English ...Danke?
Is 10$ sp any-kind of trigger num/value for AVXL or just a speed bump? I like $20 better , but can be convinced that $10-15 is a trigger also?
Agree.
HMB2010
I don't think people fully appreciate how much progress is being made in Europe.
Anavex is possibly just months away from approval there. The CHMP opinion is the final big domino to fall. There's another hurdle that needs to be cleared on Day 215, one on Day 232, and another on Day 237. By day 277, or within 67 days of receipt of the CHMP opinion that was just released, the European Commission decides on the marketing authorization's approval.
See: second table in the link below. We are currently in the Day 181-210 box but about to move forward. The dominos fall quickly from here on out.
European approval first, then Australia. This will put additional external pressure on the FDA to approve something, and it gives the -mab drugs enough time to profit what they can while they can.
The cynic in me feels the FDA hinted to Anavex to go pursue other countries first, because it didn't want to have to rule on approval of a new drug so soon after approving the dangerous -mab drugs. Call it a professional courtesy to the companies that partially fund the FDA.
https://learning.eupati.eu/mod/book/tool/print/index.php?id=893&chapterid=822
PS: Notice there are no more clock stops after the Final Discussion and adoption of the CHMP's opinion about whether Blarcamesine should proceed.
Huh...WHAT DO YA KNOW....MORE AVXL DOTS...
“The findings are very important and also quite exciting and interesting,” said Fumihiko Urano, a Wolfram Syndrome clinical researcher from Washington University School of Medicine who was not involved in this study. “It’s one of the first articles showing that targeting MAM can improve behavior phenotypes in a mouse model of Wolfram Syndrome.”
The team behind the new study didn’t pick an S1R agonist to test out of thin air. They previously showed that the S1R agonist blarcamesine protected mice against Alzheimer’s disease, a neurodegenerative condition partially caused by mitochondrial dysfunction and increased ER-mitochondrial contact (2). The drug, produced by Anavex Life Sciences, is currently undergoing a phase III clinical trial to test its efficacy in patients with Alzheimer’s disease and a phase II trial in patients with Parkinson’s disease, another neurological condition with etiology linked to misbehaving mitochondria.
Delprat and his team demonstrated that using another S1R agonist, PRE-084, to activate S1R restored the lost contacts between the ER and mitochondria in fibroblasts taken from patients with Wolfram Syndrome. The wolframin-mutation-carrying fibroblasts had fewer contact points between the ER and mitochondria than control fibroblasts, resulting in underactive mitochondria. After treatment with PRE-084, the mitochondria in the Wolfram Syndrome patient-derived fibroblasts had more contact points with the ER and produced more energy as measured by ATP production.
https://www.drugdiscoverynews.com/a-drug-that-protects-against-alzheimer-s-disease-may-help-with-wolfram-syndrome-15484
https://pubmed.ncbi.nlm.nih.gov/38097715/
Anavex's blarcamesine is a very effective anti-depressant.
Where there were only a handful of people involved in the development process for a long time, those people are usually on the patents. The patents themselves are fully assigned to the company, Anavex. There are no personal royalties that would flow through to any individual, including CM. I have 4 granted patents are all are fully assigned to the company, not me personally.
I sense that today is-will be a key point for AVXL. Report to your ready rooms. Set DEFCON II, hostilities are imminent.
The stock is clearly outperforming the XBI. Maybe the EMA news is sinking in.
rx7171...
The treated MS patients were noted as having significant reduction of brain lesions as shown on imaging.
A direct biomarker supporting reduced symptoms.
I remember a study where A2-73 re-myelinated nerves in pre-clinical rodent study...about 7-8 years ago.