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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.
Interesting to see multiple sclerosis and autism mentioned on patent application. Especially MS, which has been quiet for years. Those are two huge applications.
BRAND NEW US PATENT FOR ANAVEX
This invention addresses tetrahydro-N, N-dimethyl-2,2di- phenyl-3-furanmethanamine hydrochloride (ANAVEX2-73, AV2-73, or A2-73) ni a method of treatment for neurode- velopmental disorders. Particular reference si made to the treatment of autism spectrum disorder, cerebral palsy, Rett syndrome, .... etc.
https://image-ppubs.uspto.gov/dirsearch-public/print/downloadPdf/11839600
8.10+0.21 (+2.66%)
As of 10:02AM EST. Market open.
8.10+0.21 (+2.66%)
As of 10:02AM EST. Market open.
3. I truly want to be a part of the team that incinerates the naked shorts. Cardboard boxes under wintry bridges would be a suitable habitat for them.
Huh,
AVXL down $ in today's trades...is this being set up for a big leap today or w/news? Looks that way to me.
this forum has become groundhogs day..the same people saying the same thing everyday...wash rinse repeat
I've heard these are hard times to find good executives so this is a tough adds.
WOW, thanks very much for this posting of key information-knowledge. Although I will not claim to get it all, I have strong support for the process-thinking insight and knowledge presented as a , "CNS-Central Nervous System".
As a reader I would note the interactive Human Bio-systems discussion- and implied thesis, (which fits exactly w/how we all function). We have very few "Silver Bullet" choices in life. We are each examples of a walking dynamic BIO model. That level of knowledge and interactive reality explains a lot about what works-doesn't ALWAYS work exactly the same for each one of us and (of course) this insight explains why , "one size does not fit all...YET". Understanding (acknowledging) the interactive nature of the CNS may be humbling for many , "BUT, IT IS WHAT IT IS", NO wonder standard lab thinking and methods are less effective when applied to CNS diseases . Keep swinging , we may (probably will) eventually prove that each subject will require a unique-custom CNS treatment. (which also splains why FDA -trials standard problem solving-discovery methods have been nominally ineffective till now)
Fresh Publication on Spirit of the Coast Analytics (sotcanalytics.com)
test-why no actions/posts?
Great stuff, thank you.
hnbadger1
“reduction of brain atrophy in several
key
regions of the brain measured by
MRI.". This is a stronger statement
than in the Sept PR, which only
referred to whole brain MRI. The key
measurement of atrophy relating to
AD is hippocampal atrophy.”
Thanks Trainguy from ST
WGT
BLARCAMESINE IN EARLY SYMPTOMATIC ALZHEIMER DISEASE PHASE 2B/3 RANDOMIZED CLINICAL TRIAL
Presenter
Timo Grimmer (Germany)
Lecture Time
09:10 - 09:25
Abstract
Aims
To assess in early Alzheimer’s disease (AD) patient’s efficacy and adverse events of blarcamesine
(ANAVEX®2-73), an orally available, small-molecule activator of the sigma-1 receptor (SIGMAR1) designed
to exert neuroprotection through restoration of cellular homeostasis.
Methods
ANAVEX®2-73-AD-004 48-week study was an international, double-blind, multicenter, placebo-controlled
Phase 2b/3 clinical study. 508 patients with AD were randomized to blarcamesine or placebo. The clinical
outcomes (primary, secondary, and exploratory) included ADAS-Cog13, ADCS-ADL, CDR-SB, and CGI-I,
which were analyzed using a mixed model for repeated measures (MMRM) and biomarkers from the A/T/N
spectrum, plasma Aß42/40 ratio and brain volume measured by MRI.
Results
The trial was successful, since the differences in the least-squares mean (LSM) change from baseline to 48
weeks between the blarcamesine and placebo groups were -1.783 [95% CI, -3.314 to -0.251]; (P = 0.0226)
for ADAS-Cog13, and -0.456 [95% CI, -0.831 to -0.080]; (P = 0.0175) for CDR-SB in patients with early AD.
In addition, validated biomarkers of amyloid beta pathology, plasma Aß42/40 ratio increased significantly (P
= 0.048), demonstrating strong anti-amyloid effects of blarcamesine in Alzheimer’s disease patients, while
MRI revealed significant reduction in brain volume loss, including whole brain (P = 0.0005), comparing
treatment to placebo.
anavex_mri.jpg
Conclusions
Among participants with early symptomatic AD, blarcamesine was generally safe, well tolerated and
significantly slowed clinical progression at 48 weeks, which is also corroborated by biomarkers from the
A/T/N spectrum, including plasma Aß42/40 ratio increase and reduction of brain atrophy in several key
regions of the brain measured by MRI.
ClinicalTrials.gov Identifier: NCT03790709.
Let's give the Rett community some hope for Christmas.
..TIME'S UP.
Anyone using conservative yet realistic input data to evaluate the SP & MC covering 7 Million Europeans with Alzheimer, will come up with a number so large that it will be hard to believe. A2-73 Blarcamesine is destined to become the leader in drug revenue WW; especially later when you can add in Parkinson, Rett, and other CNS conditions and rare diseases, plus non CNS diseases listed in the pipeline.
boi568
And for all the posters complaining about the possibility of Rett and AD full data release sliding into 1Q 2024, be assured the unexpected EMA news more than makes up for that.
NICE WORK hnbadger1...This is exactly the kind of response we might expect when, "RWE-Real World Evidence" begins to get out to the ROW...along w/ " RWD-Real World Data " .
Bless us all...;
From TTT on St-
Clyde Campbell & Vicki Miller The Shake
It Up Show
Listen to Clyde Campbell & Vicki Miller from
The Shake It Up Show. On this week's
episode, we are joined by Chief Executive
Officer of Shake It Up Australia Foundati.
@ https://shows.acast.com
TTTav66 21m
$AVXL "Companies like Anavex have
got their Sigma-1 receptor drugs that
we're going to get into trial in the first
quarter of next year. They're really
exciting trials that have been done in
people with Parkinson's with
dementia, but how we actually pull
that earlier in the disease and make a
real difference in people with
Parkinson's."
- Clyde Campbell, founder and
Chairman of Shake it Up Australia on
Ep. 33 of The Shake It Up Show, Nov
15, 2023
"
remember iHub quotes are 15 minutes behind real time.
What is going on w/SP? A mess...any insights? Are we up $ 0.31 @9.53 am or not ?
Agree,,,thx and bless those RSD kids and their families...
Thanks Powerwalker...does not look authentic to me but...we'll see...all the best to every (real) AVXL investor
now this???seems like some kind of scam???
7.57+0.36 (+4.99%)
At close: 04:00PM EST
7.46 -0.11 (-1.45%)
After hours: 05:30PM EST
7.57+0.36 (+4.99%)
At close: 04:00PM EST
7.90 +0.33 (+4.36%)
After hours: 04:56PM EST
comments anyone...? real or noise?
My guess on attracting the very best would be...they are lining up to get in the door. My guess is the best and the brightest already see-understand where AVXL is headed (many CNS treatment theories discussed here with W/W results being leaked to those who GET IT). Recruiting the staff is probably not and issue. AVXL is a nucleation site for those CNS BIO-MED WW best and brightest . Stand by, this is only the beginning.