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Tred, Exactly Right; On All Accounts
Your post nailed it.
There is the general perception that Anavex Life Sciences Corp is a tiny start-up biotech out in some forlorn R&D pasture, unconnected to anything; with no real hope of corporate success. Some too-good-to-be-true molecule that magically crosses the blood-brain barrier, does all sorts of magical, heretofore unknown good things to malfunctioning neurons causing a plethora of central nervous system and other diseases. Who could believe it?
Well, I do. I’ve studied the data and papers, and have sufficient biological knowledge to understand what I’ve read. But, anyone else?
What about the hundreds of at-the-bench (lab bench, not legal bench) pharmaceutical researchers? Would their interest in scrutinizing the Anavex science parallel mine? Moreover, when reading and contemplating the many Anavex papers, would those guys (and gals) be able to understand the science as well as I? Better — with far greater implications.
No, dozens of neurologists, cell biologists, pathologists, and a host of other professionals have taken, as I did, a look at the Anavex claims. Just as did I, they expected to find all sorts of holes and question marks. And, like me, they’ve found none. Had they found any, we would have read about their obviating findings of Anavex scientific insufficiency by now.
With Anavex efficacy and safety, what do I have to lose? Nothing. I gain. But for pharmaceutical employees, from lowly lab-techs on up to research coordinators, everything neurological is at stake for them; their veritable careers. Without raising the topic at the lab dining room at lunch, researchers both in big-pharma labs and institutional labs, are just hoping, hope against hope, that Anavex 2-73 proves viable against only Rett Syndrome, Parkinson’s, and Alzheimer’s.
But as I have, they’ve scrutinized the presentation graphics and tried to find holes in the broad utility of the Anavex sigma-1 receptor agonist molecules. No holes. No mis-fitting molecules. No reason to believe the story of Anavex science told by the company is flawed in any discernable or expressible way.
The professional silence on the matter is deafening. Professional careers, indeed, are at stake. Billions were invested in the amyloid thesis, with millions of dollars of legacy research positions and programs. Now, Anavex has no need of any of that.
Can we say, "disruptive technology," in the manner, or more so, than antibiotics in the last century?
Well, The Anavex Story At Least
Thank you for that testimony.
Should be on the front page of newspapers and websites nationwide.
The Polio Vaccine Factor
Indeed there is crying need for something better than the current SOC [standard of care] in PD and Rett's...and advocacy groups ready to press for rapid approvals in both of those indications!
Anavex Info From Company, Online Papers
You are a very prudent person. May I ask you how you found Anavex’s science?
It’s Not Fear — Safety
Love the safety profile ...
I Don’t Try to Time the Market
If you expect this will be "dead" money for so long, why invest now?
2023 Is Only An Investment Target Year
2023 is the year I will decide if my modest investment in AVXL will have been a success or failure. I presume that it may take that long for a) clinical trials to yield their data, b) for FDA to approve commercial sales of Anavex 2-73, c) for substantial corporate revenues to accrue from such sales, and most importantly, d) to assess the share value or consequent dividends to share holders.
I knew from the start, from the purchase of my Anavex shares, that the dollars so-invested would be "dead," yielding no returns for some good time. As we've all seen, getting a new, innovative drug to market, to profitability, is a many-years process.
As a biologist, I understand more than most the unique biochemistry and cellular physiology of this sigma-1 receptor agonist, and how it has the potential (profusely demonstrated and affirmed in murine [lab rodent] studies) to profoundly treat a number of central nervous system diseases. With all of that, I have strong confidence that my Anavex investment will eventually (by the end of 2023) pay off quite handsomely.
The only decision I think I'll have to make in 2023 will be to weigh the benefits of liquidating any or all of my AVXL position; or holding the entire investment and reaping the rewards in the form of dividends.
I think the latter will be the case. I'll delightfully receive Anavex Life Science Corp dividend checks. The shares themselves will eventually pass on to my son and daughter.
And (not that this influenced my taking of my AVXL position --- didn't know about it then), a murine study of Anavex 2-73 in transgenic rats with my particular central nervous system affliction, a mild case of hereditary spastic paraplegia (sporadic case, not inherited), was successfully treated. Like myself, the rats had stiff rear legs, and a spastic gait. A few milligrams of Anavex 2-73 in their drinking water restored normalized long motor neuron function in the spinal cord. Normalized gait was gained.
I'm eager to be one of the first people with HSP to try Anavex 2-73, off label, for my peculiar CNS affliction. Knowing already the safety profile of the drug, I'd pop the stuff right now, were it available.
Only Catalyst Will Be News In Popular Media
What do you think is the next big catalyst?
Hidden Info Is Purposely Undisclosed
...for now, the cloak of silence is necessary.
How Would This Play in the US?
...to allow for accelerated public access to new medicines in Australia prior to the completion of a clinical trial’s collection of data, where the medicine is likely to provide a substantial benefit for Australian consumers.
But The CTAD Answers Counted The Most
As I've said, the CTAD data generated many more questions than answers.
Ponder the Implications of Sleep Disorders --- And Anavex
A major paper on sleep disorders in the U.S. makes these important points:
The International Classification of Sleep Disorders distinguishes more than 80 different disorders, which can be effectively treated. Problems with falling asleep or daytime sleepiness affect approximately 35 to 40% of the U.S. adult population annually and are a significant cause of morbidity and mortality. However, the prevalence, burden, and management of sleep disorders are often ignored or overlooked by individuals and society in general. This leads to an underappreciation and undertreatment of sleep disorders, making this group of illnesses a serious health concern.
Aging and Anavex
Wikipedia lumps all of the following under “Mitochondrial disease:”
Symptoms [of mitochondrial disease] include: poor growth, loss of muscle coordination, muscle weakness, visual problems, hearing problems, learning disabilities, heart disease, liver disease, kidney disease, gastrointestinal disorders, respiratory disorders, neurological problems, autonomic dysfunction and dementia. Acquired conditions in which mitochondrial dysfunction has been involved are: diabetes, Huntington's disease, cancer, Alzheimer's disease, Parkinson's disease, bipolar disorder, schizophrenia, aging and senescence, anxiety disorders, cardiovascular disease, sarcopenia and chronic fatigue syndrome.
Ophthalmologists And Optometrists Will Detect Prodromal Alzheimer’s
The results from two studies presented at the annual meeting of the American Academy of Ophthalmology show that an eye scan from a new imaging device may be an easy and non-invasive way of detecting Alzheimer’s in patients within seconds.
Prevention of Alzheimer’s by Earliest Administration
That [testing] would enable very early diagnosis and allow for 2-73 treatment which could delay onset of clinical symptoms for many years if it doesn't outright stop further progression.
“We’re not prepared....”
An article in The Washington Post, by a practicing nurse practitioner in the palliative care field, entitled, “We're not prepared for the coming dementia crisis.”
https://www.lmtonline.com/opinion/article/We-re-not-prepared-for-the-coming-dementia-crisis-13339813.php
In short, the Alzheimer’s dementia problem will become a crisis of the greatest costs, with no existing solutions. Desperation will set in, not just in patients and family members, but in the citizenry in general.
We (as we have and will) can bicker over the significance of various clinical data revealed at the CTAD conference. But all of us, for or against or puzzled by Anavex, are missing what most likely will be the big, emerging issue.
Slowly, but definitively, the inadequacy of the few currently-approved Alzheimer’s drugs as effective treatments is being realized. They merely slow the lethal progression of the disease.
But far bigger is the realization that none of the other treatment approaches, mostly immunological, against the toxic waste proteins of Alzheimer’s, beta-amyloid and tau tangles, are ever going to solve the problem. They don’t work.
In the face of millions of Americans advancing into their latter decades, what, then, are the emerging new treatment options? There are none — with one exception, Anavex 2-73.
“But wait a minute, there, Falconer, that drug is no closer to therapeutic usage than any of the others. It’s not FDA approved, and won’t be until positive Phase 3 clinical trials emerge?
Ok, granted. But let’s see what desperation evokes. Sooner or later (probably later), writers looking for stories on the Alzheimer’s crisis will have to tell the Anavex story. It’s not yet complete by any means, but the existing clinical data are more positive than with either the existing acetylcholinesterase inhibitor drugs (the ones that merely slow disease progression) or the failed waste-clearing drugs. Simply, Anavex is the only glimmering light in the dark corners of the Alzheimer’s pharmacy. In time, writers will have to relate the progress and outcomes of the three clinical trials of the drug.
If any one of the three yields decidedly positive outcomes, real disease treatments, the game (and public perception) of the Alzheimer’s crisis will change. Eventually, popular media will have story titles with the theme, “Anavex showing the way on the Alzheimer’s problem....”
What Specific CTAD Data Obviate Sales Approval?
Now that everyone has had some time to scrutinize the data and information laid out at the CTAD conference, please list the findings that clearly obviate or restrict eventual FDA (or other national health authority) approval for the sale and use of Anavex 2-73. Anyone see any such data?
No, this is not a request for CTAD information that supports sales approval. That specific information can only come from the upcoming Phase 3 double-blind clinical trial involving 450 subjects.
But for those holding AVXL positions the CTAD presentation of the 148 weeks of clinical data of Anavex 2-73 is important. Specifically, are any of those data negative to the degree that eventual sales approval of the drug is now in question?
SAE = Serious Adverse Event.
A really bad side effect in a clinical trial.
My Anavex Grin Continues
Just scanned the presentation PDF. Will scrutinize it for arcane details later.
But very clear. The positive, unique nature of the Anavex science persists, is further confirmed. Tolerability and adverse events continue to be minor, are infrequent; utterly inconsequential.
Treatment outcomes clearly eclipse those of the existing standard of care Alzheimer’s drugs, the ones Anavex must beat in order to gain FDA sales and use approval.
No, FDA approval won’t come from these particular data; will require the being-arranged big Phase 3 clinical trial. But now, not a nanopartical of evidence that the Australian Phase 3 trial will fail to yield eventual sales and use approval results.
As before, but a matter of time. Those betting on an Anavex failure (those shorting AVXL) just had two fastballs over the plate. Called strikes, every one.
Shorts haven’t a chance. All fastballs over the outside corner. Three strikes (well, three studies: 1) early Phase 1, 2) this continuation, and 3) the up-coming Phase 3), and you’re out.
The balls and strikes count for the shorts is now 0 and 2. No balls and two strikes.
Anavex Not For “Most”
...most investors actually want a premium stock price, not a depressed stock price.
Diverse Investment Objectives
Awaiting a Super Lotto win is not the preferred path to financial independence.
There Are No "Algae Blooms"
Algae bloom [sic] toxin linked to Alzheimer's, other diseases
Treatment Persistence
Neurotrope putatively has a competitive drug. Well and good. But might there be a significant difference between Neurotrope’s and Anavex’s therapeutic approaches?
The company states, “Neurotrope has targeted Bryostatin-1 due to its high potential and multi-modal efficacy: through protein kinase C (PKCe) activation, Bryostatin-1 stimulates synaptic growth factors, amyloid-ß degrading enzymes, as well as prevents Tau transformation into neurofibrillary tangles.”
“...protein kinase C (PKCe) activation...” and “...amyloid-ß degrading enzymes...” mean that the drug interacts with, “activates” particular enzymes. Therefore, to maintain efficacy, the drug must be administered chronically, without interruption. Stop dosing the drug, and the targeted enzymes are no longer activated. Symptomatic progression of Alzheimer’s would resume.
Will this be the case with Anavex 2-73? That sigma-1 receptor agonist re-connects — perhaps for long or permanent periods — endoplasmic reticula with their associated mitochondria. It's not an enzymatic process.
Those organelles took many years, perhaps decades to become dis-attached. When re-attached by Anavex 2-73 therapy, what is the likelihood that they will again become physically or chemically disconnected soon or immediately after a course of Anavex 2-73?
Because of how the Neurotrope drug works, by “activating” enzymes, the efficacy of those activated enzymes will not persist at the termination of Neurotrope (Bryostatin-1) dosing.
That may not be the case with Anavex 2-73. Once the two organelles have been sufficiently re-connected, after a useful period of dosing, it may take additional years or decades for them to, once again, break apart.
Necessarily, Bryostatin-1 treatment will be chronic, without interruption (for life). Perhaps not so with Anavex 2-73.
Perhaps there will be indications of persisting Anavex 2-73 efficacy in the CTAD data; where perhaps some in the trial discontinued treatment and symptoms did not quickly reappear.
Clearly, Bryostatin-1 treatment must be chronic, enduring, without interruption. Let’s see if that will be the case with Anavex 2-73. It’s organelle re-connections may be more permanent or enduring. A big difference, in multiple ways.
No Matter What Is Said....
I for one will be interested in hearing what they have to say about the 148 week results re: the original group of 32 patients.
The Only Press Coverage That Will Count
The only press coverage that will make a useful, continuing share price difference for AVXL will be continuing and replicated press reports in the popular media of clinical trial participants experiencing significant symptomatic improvements.
Because of blinded trials, some believe such reports could only appear after the trials are completed and results are formally announced. If so, for the Rett trial, nothing in the press for Anavex shareholders until next year.
But, take for example the Rett participants; all little girls (the Rett gene is sex-linked; kills little boys with it on their single X chromosome, but little girls, with two X chromosomes, can have one X chromosome with a normal gene, allowing them to have severe symptoms but survive). Among other debilities of the disease are sleep problems. What happens if a good number of the first little girls dosed with Anavex 2-73 begin to sleep well? Would a number of enthusiastic mothers telling that to news writers or reporters be silenced? Would there be a news article there? Would it appear in the media somewhere?
Now if it were but one or two Rett girls and their mothers, no story. But five, then six, then ten? (I'd love to write that story. But someone else will, when it evolves.)
Really? The Board Controls Clinical Results?
Drug has not proven anything. Company still needs to fire the board.
Well, Let’s See
Could it be that Anavex 2-73 ability to create homeostasis could eleviate [sic] or fix pre-existing psychiatric conditions in patients with Alzheimer’s or Parkinson’s Disease or those with psychiatric conditions in the general population.
The Enzyme Factor
I cannot elaborate on the involved specific chemistries or physiologies of the various chemical entities described in the reading. Beyond my knowledge or comprehension; won’t venture into an area for which I have insufficient knowledge.
Nonetheless, I do note the involvement or reference to a number of enzymes, or their pathogenic products. Once again, two questions. What is the direct, frank, observed pathology; or much more importantly, what is the root, primal cause of the pathology. The reading refers to a number of chemical abnormalities strongly associated with Alzheimer’s (at various disease stages). These abnormalities can occur for (primarily) the following reasons.
Bad genetics. A mutation, a disrupted nucleotide sequence in a chromosome, causes wrong chemicals (proteins, usually in the form of enzymes) to be formed. Normal neuron chemistry does not then occur; a disease condition is created.
Good genetics, but abnormal enzyme synthesis. In this case, genes are normal, properly instructing the neuron to synthesize functioning enzymes. Enzymes simply control virtually all cellular chemical reactions in the cell. If they are properly (normally) formed, proper, healthful chemical reactions occur. All is well. But if the enzymes are not properly synthesized, if, for example, they are not properly folded into their precise configurations, pathology results downstream. In the case of Anavex 2-73, it restores proper function to the rough endoplasmic reticula, the organelles that synthesize enzymes. Cause the rough ER to properly fold enzyme proteins, all is well. If they are mis-folded, reactions fail, or (as in the case of the several molecules in the article) reactions or processes downstream are compromised; pathologically.
Lastly, but not in this case, metals or other enzyme toxins can disrupt enzyme production or function.
Once again, unlike any other known (to me, at least) potential Alzheimer’s therapy or drug, Anavex 2-73 corrects things at the upstream base; allowing the cell to once again synthesize normal enzymes. It fixes the root-cause; mis-folded enzyme proteins in the rough endoplasmic reticula.
My reading of the referenced information indicates a focus on various downstream outcomes. The upstream root causes are not addressed. Again, Anavex 2-73 is different — and so much better — in that regard
Anavex 2-73 Side-effects
Anavex has said in the past that the potential CNS side effects of mild to mod dizziness and headache often go away over time as the patient's body ajusts [sic] to the medicine.
The Market Doesn’t Understand Neuron Cytology
If it is so special, then why does the market think otherwise?
Well, For Smart People, They Don’t
How exactly, from a blind study, do ANY early results dictate a result?
Won’t Matter To Smart People
Will it matter if patients are now living normal lives after being treated with A2-73?
“Precision Medicine” Imprecise Without A Working Drug
As useful as precision medicine might turn out to be, where precise diagnosis matches applicable drugs to particular diseases, it is simply pointless when there is no drug to effectively treat a particular disease. Presently, such is the case with Alzheimer’s, Parkinson’s, multiple sclerosis, and many other central nervous system conditions.
The controlling matter will not be “precision medicine,” neither for Anavex nor for any other company or drug. Simply, will there be a drug that effectively, safely treats a particular disease? Gotta have the drug, first, before precision medicine can be used. In their pipeline, Anavex Life Sciences Corp has such; all awaiting the required clinical trails to affirm safety and efficacy.
I’m not much impressed or excited about precision medicine. My focus is on the actual drug that is safe and efficacious. More so than any other pharmaceutical, Anavex Life Sciences Corp has new, proprietary molecules that, after proper clinical trials, will prove to be safe and efficacious. But a matter of time, not “precision medicine” per se.
Ok. But, So What?
Any thoughts or comments on this PR from BIIB today.
Any Of Those Coming; Trials Or Good Results?
Anavex will have to continue without a partner unless and until there is a very compelling data set from larger, well designed, placebo-controlled P3 trials.
Staying Up To Date
Each day, I read through the recent postings here. For me, not finding anything of general use or application. I’m a retired biology teacher, usefully knowledgeable about biochemistry, cytology, and other biological factors involved with the Anavex sigma-1 receptor agonists. I don’t have multiple thousands of discretionary dollars for an equity having no revenues or products. I’ve invested my moderate funds in the acquisition of a number of AVXL shares — fully understanding that this might be an investment loss, or that to be a gain, especially into my anticipated three-digits value, many years will have to pass.
For me, Anavex Life Sciences Corp is a long-term investment. Matters happening (or not), day to day, even month to month, are essentially irrelevant. I read about and watch them; but they in no way change my perspectives on my moderate investment. As I’ve mentioned before, my year of decision, figuring if this was a gain or loss, will be sometime in 2023, five years away.
By then, clinical trial results of Anavex 2-73 against at least three central nervous system diseases will be fully known. If all three fail (for biological reasons, I can’t see that they could), no drug sales; I’ve lost my dollars. If any one of them succeeds, especially the Alzheimer’s or Parkinson’s trials, I will be handsomely rewarded.
Wish I had some more discretionary dollars to invest. But, I don’t. I have a nice federal income tax refund coming. But that’s for our joint filing. Have the good sense to not even approach the dear wife about this. She knows (and cringes) that I’ve forked over some (well, all) of my fun money on Anavex. I must remain quiet and content, allowing the trials to play out.
When the first leaks of positive results appear, and the share price starts to ascend steeply, above a ten-spot, I’ll then be in a position to casually mention the matter to the wife. I’ll of course, say, it will be fun watching the value increase each week, letting it run. She is in a position to take a substantial AXVL holding — but far be it from me to even mention the opportunity (at any share price).
But if she eventually, per chance, says, “Say, John, could I buy a bit of that company?” “Why Sarah, so glad you asked. Yes, I can work that out for you, right now.”
Like so many others, she may be chasing the AVXL share price once positive trial results push it. I can’t imagine anything else that will do it. Even the most positive CTAD data won’t push AVXL more than a few dollars. Then, as weeks plod onward, the share price will retreat. Only one thing will drive the Anavex share price: all-embracing evidence that Anavex Life Science Corp will become profitable. Until then, I’m just standing by, watching, waiting, playing the tedious long game.
No Alternative
Why did the FDA continue/or allow the continuance of Amyloid Thesis based trials for decades, long after any child could see they were going nowhere? (see 99.6% failure w/> 1000 attempts over 20+ years).
It's What I Do --- I'm A Teacher
Falconer, Thank you for taking the time (your time) to post a response to my post.
Well, Psychotropics Are Prescribed
Up to half of people with Alzheimer's disease (AD) use a psychotropic drug, and one in five uses two or more psychotropics concomitantly, according to a study conducted at the University of Eastern Finland.
Psychotropic drug use was more common among persons with Alzheimer's disease already five years before the diagnosis, and the difference to comparison persons without AD increased at the time of diagnosis. Four years after the diagnosis, psychotropic drug use was three times more common in persons with AD than in comparison persons.
New Therapy Will Be No Better
The new therapy is merely a new way to clear or keep from accumulating toxic waste proteins. Fine and good, except....
The root problem is not the accumulation of the toxic waste proteins, it's their upstream generation, in the first place. That's where Anavex 2-73 is so different and so much more effective. It allows the neuron to properly and normally fold proteins in the endoplasmic reticulum. With that, yielding folded, functioning enzymes, waste proteins are properly processed and lyzed (chemically pulled apart) into more elemental factors that are properly re-used or excreted. No toxic accumulation. Normalized nerve function.