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Anyone else think it is ODD that the normal AVXL pre-open chatter has been missing today? What's UP?
Find a way to accelerate the discovery/resolution process.
Many of us have experience working directly with regulatory bodies in resolving technical problems. Generally such bodies resist change of just about any kind. Changes often involve some level of risk management even rewriting the book of rules/guidance docs. No one wants to put their name on risky things or even be in the room when that discussion happens, never mind be the fool driving for change...they are ...."toe-less wonders".
We recognize that FDA top management are risk averse , they need to turn this into a strength ASAP. Other industries have done this. The MED-PHARMA -FDA need stop relying on statistical models to cover their AXXS and fix the science instead. They can begin by sitting in a room w/people like dr.M. and JUST LISTEN..
Too many innocent people have suffered and died already. Statistical models are being used to cover people's axxes. At this rate, we will all be dead before these guys get it.
I once helped a very brave & smart regulatory leader drive change which accelerated the rate at which highly complex semiconductor devices failed in military and commercial , space flight applications. The bio-physics were on the same level of complexity as these CNS-Bio-Pharma products and the consequences of failure were literally nuclear. If we look closely enough we will find other such examples in industry everywhere. Risk analysis/diagnosis tools-methods are how progress is made. Change is not a subject to turn away from when it is as obvious as this entire CNS regulatory body of work demonstrates.
First, Find a way to accelerate the RATE of failure in the LAB and then develop methods/science/techniques needed reduce/eliminate that root cause. Then prove effectiveness through zero risk application once the model is implemented through careful development of root cause analysis and then effective preventative techniques. (SEE Rome Air defense Center , RADC) development of HTRB as a mechanism to induce/cause failures in complex semiconductor devices and fire control and comm. systems.
Amazing that after one week of being off the drug, she reverted back to her horrible symptoms.
Dr.M., if you read these messages, THEN LISTEN UP. I am a long time AVXL supporter holder who is nominally supportive of just about everything AVXL has done. I am running out of string though. We just have to make-get an economically and medically -effective viable CNS (AD) treatment out the door, NOW...not..SOME DAY, maybe.... NOW..., make that happen.
Within the past 30 days my identical twin brother passed away from complications of AD . He had the very best care available and in the end (IMO) he just gave up, after many falls, and complications typical of AD.
So my request is to take risks like you never dreamed you would and do whatever is needed to get this CNS treatment out the door and commercially available. BR...and I REALLY AM a NIDAN . Bless you and your team.
xodcode
Any positive price change these days is nice to be sure, but the big price move awaits positive RETT results.
AVXL, at current levels. is HUGELY undervalued. I mean, since seeing $30, we've had nothing but HUGE and POSITIVE test results across multiple diseases.
8.72 +0.31 (+3.69%)
After hours: 04:28PM EDT...
Any thoughts on why this jump after hrs on Monday 5/8/23?
IMO, AVXL has taken a leadership position favoring RESTORATION to every human system and natural functions. FDA systems and methods have clearly failed to guide-direct or to lead.
J_K
I think most of that growth will relate to aspects of "commercialization," not to the drug-testing that was the company's sole focus until recently.
$money bags$
We need the CEO to push this thing over the finish line. He doesn't even acknowledge delays, they are just part of his DNA I guess.
8.40+0.06 (+0.72%)
At close: May 4 04:00PM EDT
8.57 +0.17 (+2.02%)
Pre-Market: 08:02AM EDT
IS $8.50 the MAGIC NUMBER OR NOT?...FCST suggests a showdown...
It's time for a little display -audition from the RSD...kids CHOIR signing their theme..."WE ARE THE WORLD".......RWD-RWE can be very effective when done well.
"This is not a drill". ..."Pilots and crews report to your Ready Rooms".... " Prepare the flight deck to commence Air Operations". ...
Lets all pray that AVXL-S1R becomes CNS systems solutions for those people who have been told..."Sorry, no effective treatments are available".
Just another good reason to own AVXL stock...feeling better already.
Tredenwater2
Anavex advantages of Rett Syndrome approval over Arcadia.
1) 100 million dollar voucher and data can be used to help support/submit for Alzheimer’s approval.
2) Anavex has partnered with Rett Syndrome.org and RAM which are worldwide and will help get the word out upon approval thus helping to accelerate sales and market penetration due to superior efficacy and more importantly lack of horrible side affects coupled with liquid formulation, huge!
3) should help accelerate the approval of future Rare disease trials where symptoms overlap. Yes, a few more trials still need to be ran but imo that would be it before prophylactic rare disease use. Dr. Missling has eluded as much as he has picked Rare diseases with a broad range of overlapping symptoms.
4) massive acceleration into a rare disease mini behemoth pharma allowing Anavex to stay independent and grow by funding as many trials as it needs for pipeline expansion.
Cheers
Is it possible trading has been suspended?
Any thoughts on todays AVXL Pre market lack of action shown??
Anavex Life Sciences Corp. (AVXL)
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8.34+0.34 (+4.25%)
At close: May 3 04:00PM EDT
8.34 0.00 (0.00%)
Pre-Market: 07:15AM EDT
AVXL staff and shareholders are now experiencing our own..."Petri Dish (anti-biotic) Moment". It may take months before the proof-dust settles but it will settle eventually. We should not expect the entire R.O.W. to "Get It" right out of the chute ...many will resist/others will present variations/alternatives ...AKA , "Snake oil".
I predict that the OFFICIAL DECLARATION of the END (DAS ENDE) to the CURSE OF AD can be expected w/in a few days/weeks months....FINALLY then a new way of LONGER, HAPPIER, MORE COMPLETE life may begin for all.
https://finance.yahoo.com/news/lillys-donanemab-significantly-slowed-cognitive-100000337.html?.tsrc=fin-srch
Infusion based treatment . Beating same ole Amyloid pony.
Anything under $10 billion would be a no-go. SIGMACEPTOR platform is this century’s breakthrough for multiple indications. The current market cap is PALTRY.
Thanks for posting this georgejji,
https://www.news-medical.net/news/20230425/Researchers-discover-a-receptor-and-protein-associated-with-Lou-Gehrigs-disease.aspx
Tredenwater2
We are duplicating them road map that cancer treatment has traveled once treating the symptoms only to move on and help the body treat andheal itself. This is part of the vision that is unfolding before our eyes, a new platform drug that is using trials to prove its efficacy to treat many symptoms that have no disease barrier. The body is so much better at healing itself than being micromanaged by scientists who try to block, silence, or remove. For every action there is a reaction that is unexpected many times with equal to or worse side effects than the condition being treated.
bas2020...
Let's review, again, the results of the "P3" AD trial...
1. All endpoints met: ADAS-Cog, ADCS-ADL and CDR-SB.
2. Odds Ratios highlighting the Super Responders for both Cog and ADL.
KEM and subgroup analysis, MRI results and Study data are forthcoming to detail the efficacy aspects and demonstrate additional benefits in the study.
It's that simple.
sumbuysumsell
Too Good To Be True.........
"so good that it is hard to believe, or seeming very good but not real"
Any thoughts or hard evidence on what the trading pattern means/suggests this AM?. Jumpy sp, w/lots of small qty buys?
BINGO...Jimmy _ mcyoloswag...S1R is a winner and a recurring key in the human systems being interactively-systemically linked (key words... CNS systems all linked). Heart, brain, key organs are each wired to and Bio controlled by human situational reaction to STRESS. BINGO, it all makes sense. We are on the right track. IMO, S1R is the recurring Bio-chem link. (only a matter of time until CNS Bio-MED DOTS start connecting).
"Blarcamesine, for the heart and for the soul" :
https://academic.oup.com/cardiovascres/article/93/1/6/415113?login=false
Treden...I believe it would be appropriate to consider that every fiber in our human CNS links are actually mini-micro conducting elements used for micro-trigger-bio impulses (some micro-bio induced) and that these micro-fiber links are not being given the credit-recognition they should get. (ask falconer how nerves are linked-communicate). It is the only plausible explanation for how(when we snub a toe) the pain signal gets to the right place in the brain and we react, we even know which toe was hurt. There must be an effective (electro-bio-chem.)micro linkage system to make all this happen. IMO, we are already prewired like a computer but in some (rare)cases those links are not set correctly -broken-blocked-deteriorated..etc. . In my simple thesis we are all a bundle of micro fiber links , some work better then others. S1R, is the Juice.
In my simple minded CNS model S1R (see falconer) links and micro bio must work in a balanced systems manner or you will miss that 3ft put every time.
So, the Central nervous System processor needs to have effective links which allow the brain to do-drive-signal the required control functions. Much bigger system than my simple model . The point is , we are all systems w/links, S1R is a critical micro-bio glue to make it work .effectively (IMO).
SO MANY DOTS, SO LITTLE TIME..."SYSTEMS HAPPEN".
Falconer66a...
Not at all unexpected, given the drug’s ability to safely modulate and restore a wide variety of homeostatic processes, both in cells themselves, and in tissues and organ systems. There will be more revelations of a similar nature in the future. Anavex knows more than most can imagine about their unique new candidate drugs.
Two key points. First, unlike most drugs blarcamesine acts at the top, at the start, “upstream” of cell, tissue, and organ-level processes that can be disrupted to cause disease.
Secondly, do you suppose blood pressure readings have been taken rather frequently in the hundreds of patients in clinical trials involving blarcamesine? The office nurse takes your blood pressure every time you stop in your general practitioner’s office. Simply, blood pressures are taken universally in medicine, surely in clinical trials of new or candidate drugs.
Consequently, Anavex has copious records of how blood pressure was affected when blarcamesine was taken.
Then, of course, is the absolute safety of the drug. Not a single case of drug-induced mortality or severe side effects.
The potential market size for a safe, successful hypertension drug in the US is, shall we say, large.
Eventually , S1R may be seen as Nature's Secret Sauce for AVXL , "Wonder Juice".
[quoteAnavex Life Sciences Corp.
Anavex Life Sciences Corp.
NEW YORK, May 01, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, announced today it was granted a new U.S. Patent No. 11,622,955 entitled “SIGMA-1 RECEPTOR AGONIST SYSTOLIC BLOOD PRESSURE THERAPY,” from the United States Patent and Trademark Office (USPTO), expanding Anavex’s coverage of treatment methods for ANAVEX®2-73 (blarcamesine), to the treatment of systolic hypertension, or lowering systolic blood pressure.
“We are extremely pleased with the expansion of the patent portfolio for ANAVEX®2-73 (blarcamesine) for the indication of hypertension which affects nearly half (47%) of adults in the United States, especially since elevated systolic blood pressure is a major health economy problem within our aging society,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “This new patent will add to our already robust patent portfolio relating to ANAVEX®2-73, and further demonstrate our strong overall commitment to protecting the full range of commercial opportunities of our product portfolio.”][/quote]
chrismass_everyday
https://imgur.com/a/Z4jOSiU
Even after the hiatus known as a “drug holiday”, blarcamesine still proved effective in patients.
Agree. Australia is by far the preferred regulatory system -pathway w/focused and experienced staff to support doing business in all SE Asia. Dr.M. MUST AVOID getting linked directly w/China regulatory bodies.
Best of luck w/the pain recovery. Many here may be older. Being in serious pain only makes the entre process tougher...life is ALREADY tough enough. Best wishes...we never leave anyone behind.
Nice catch...tschussmann1
Low volume all day, then 200K at close. Feels like stealth acquisition or covering short positions...
Talon
A big market, but a very bad geo/political move. When (not if) there is conflict over Taiwan, commercial pipelines of all goods will be severed.
8.39 +0.15 (+1.82%)
Pre-Market: 9:21AM EDT
Premarket sp is bouncing around this AM. This looks A-B-NORMAL, or is it me?
sab63090
I wonder if $BIIB might be interested since they have had 2 failures now?
Talon38
New statement from Biogen's management admitting the difficult "struggle" with Aduhelm", the hurdle for Lequembi i.e. its necessary infusion obstacles and the target for the Alzheimer's market in the realm of $30B a year.
tredenwater2
There is a lot of pride out there imo that will need to be “unwound” through/behind “revelations” from the PR machine from the likes of AF, Motley Crew, or Cramer types.
As we (finally) watch a very nice GREEN AVXL sp today let's all pray that it is for real this time and that this action may be taken as a predictor /pointer to those WW CNS diseased patients-families will each have something positive in their near future.
Blarcasamine
Ready for commercialization, very close to commercialization !! Statement from todays conf call.
K
Do you know how recently they changed the website to include the new "commercial stage" focus?