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There are good reasons...
The homeostasis (normalized function) restored by Anavex 2-73 is not and should not be regarded as a "side effect." It is the primary, desired outcome --- unlike anything else treating disfunctional neurons.
Good questions; valid concerns — with useful answers.
If Anavex technologies (candidate drugs) are such powerful and safe Alzheimer’s treatments (along with many or most other CNS degenerative diseases), just why are there a) no substantial proclamations of validity from external “experts” or authorities, and b) why no useful press coverage?
Even more concerning is the relatively low share price. It’s been slowly elevating of late; but nonetheless, many of us AVXL longs think fair share prices are many dollars above the current $5 – $6 range (well, many, many dollars more).
First, few people have the biological or chemical knowledge to adequately and sufficiently understand the rather complex biochemical and cellular biology mechanisms by which the Anavex sigma-1 receptor agonists function, how they restore cellular homeostasis.
Most investment advisors and commentators couldn’t even define “cellular homeostasis.” They’d have to (but many haven’t yet) look it up on Google. Nor will they even know what an “agonist” is. Move on to the complexities of mitochondrial connections to the rough endoplasmic reticula, with adenosine triphosphate synthesis and transfer, coupled with calcium ion gating and signaling — all of which folds waste-clearing enzymes properly (and much more), and we have people in way over their heads. To them, sounds lake make-it-up chemical or biological hocus-pocus.
If it’s valid — and they have no way of knowing — it’ll all show up in “proper” Phase 3 double-blind clinical trials. Without those, financial analysts can confidently and powerfully say, “Stay away! The science is unproven. Don’t bet your dollars on such a far-out, yet to be proven medical technology. Remember, billions have been spent trying to find an Alzheimer’s drug. Every one has failed, and so will this one, it appears.”
Only one way around all of this. If FDA approves Anavex 2-73 as a drug to treat the orphan disease Rett Syndrome, and all of a sudden, little girls who have the disease (males seldom if ever have it) start to live normal lives and loving parents become ecstatic about their children’s normalized future, the press will write that up.
The proof will be in the pudding, the treated kids.
Or the pudding may be Down Under, should the Aussies move Anavex 2-73 to their market sooner than the FDA here. It’s one thing for a few “strong responders” to revert back to normalcy in an early clinical trial. Quite another when common citizens report remarkable symptom turn-arounds from a drug they bought at the pharmacy (well, in Australia, at the “chemist”).
Until any of that appears, AVXL equities are likely to stay cheap and not fully appreciated. The game belongs only to the longs.
What, per chance, are the implications (and chances) that Anavex drugs get approved and used in foreign countries before the US; such as Australia, and here, Germany?
Are we overly fixed only on domestic, FDA approval, whereas Alzheimer's and other CNS diseases are profound problems elsewhere, too?
What happens if, say, Australia first approves Anavex 2-73, with consequent good and rapid results in the tens of thousands down under then taking the drug?
When, and how, does Anavex 2-73 get approved and come into widespread use in the rest of the world? CNS diseases do not proliferate only in the US; they are worldwide problems --- with a US-based solution: Anavex.
Global, not just domestic perspectives should be pondered.
This is an utter non-issue; alarming only to those lacking elemental chemistry knowledge.
ANAVEX 2-73 is a tetrahydrofuran derivative, not tetrahydrofuran itself. This means that any number of side groups or other chemical appendages have been attached to the tetrahydrofuran base, thereby changing its toxicity and chemistry altogether.
To make this simple, for those with minimal chemistry background, an equivalent statement would be:
"Be careful, table salt is derived from chlorine, and it's strongly toxic."
(Table salt --- sodium chloride.)
Rats and mice validation is valid.
Mycroft brilliantly laid out how Anavex 2-73 promotes cellular health (normalcy, “homeostasis”), in a duel fashion.
Most drugs promote health by affecting or controlling single molecular reaction pathways.
For example, aspirin works by locking onto cyclooxygenase 2 (COX-2), an enzyme involved in pain signal transmission. It chemically disables COX-2 molecules, thereby reducing pain signal transmission.
Anavex 2-73, inside neurons works in remarkable, multiple ways. It facilitates the healthful, multiple roles of the sigma-1 receptor. No other drug has been shown to usefully do this clinically.
CNS diseases need functioning sigma-1 receptors. In youth, sigma-1 chemistry is normal, with normal, healthful neurons. But with age (or other factors), normal neuron chemistry is disrupted.
Primarily, but not uniquely, energy-producing mitochondria become disconnected from rough endoplasmic reticula, where properly-folded enzyme proteins are produced and control normal cell function. In these aberrant conditions, Anavex 2-73 re-connects the mitochondria and endoplasmic reticula. Health-giving enzymes are then again produced.
Essential Ca+ signaling, among other effects, is also restored and enhanced by Anavex 2-73.
Anavex 2-73, by facilitating normal sigma-1 receptor functions, promotes healthful neuron chemistry. Although a bit over-stated, it’s like a diligent mother inside the neuron, keeping all of the chemical children in good order and discipline. She carries a big stick, and doesn’t hesitate to slap things back into order.
All of this is SO different from the many, now-failed Alzheimer’s treatment drug candidates. First, none of them work; and all have single, narrow molecular pathways they are supposed to affect. Smart investors, after doing deep due diligence (attempting to comprehend the unique, broad-spectrum functionality of Anavex drug candidates), should recognize how Anavex is entirely different; that lumping Anavex 2-73 in with all the other failed and proposed Alzheimer’s drug candidates is a gross chemical and investment error. Healthful apples and toxic oranges, as it were.
But, for due diligence, another unique, favorable trait of Anavex 2-73 should be noted.
All of the above would be irrelevant, were Anavex 2-73 to have, as do almost all nerve-acting drugs, severe side effects. Not so with this molecule. After adequate human testing, not a single significant (disqualifying) adverse event was recorded. No strokes. No hemorrhaging. No psychoses. No heart attacks. Just a few mild headaches or upset stomachs and the like. All of which would be usefully tolerated, given the stunning symptomatic relief Anavex 2-73 promises for those with Alzheimer’s.
Post #93794 explains it well.
(Better than I could have.)
No, Anavex 2-73 will not cure Alzheimer's.
That's because the root cause(s) of the disease will remain in any person treated with the drug. Stop the drug, and the disease symptoms are likely, in time, to resume.
Insulin does not cure diabetes. It controls it. Anavex 2-73 can do two things; prevent the onset (appearance) of CNS diseases, or, stop or reverse their progression.
The likelyhood of just popping a few Anavex 2-73 pills for a week or so to permanently prevent or treat any CNS disease is remote. As with insulin in diabetes, patients will have to take on-going, maintenance dosings of Anavex 2-73.
Of course, this is exactly the kind of product Big Pharmas want in their arsenals, drugs that have to be purchased continually, creating persisting revenue streams.
And this is why Dr. Missling will be extremely reluctant to sell off Anavex technologies to other companies. Keep the proprietary molecules in-house, yielding stunning, persisting financial rewards. External firms may be engaged in manufacture, packaging, distribution, and sales. But Anavex Life Science Corp. reaps the primary rewards.
Anavex Life Science Corp. I believe, is destined to be a Big Pharmaceutical. Those of us with AVXL shares will be well-rewarded — as will those who are treated with Anavex drugs.
I read virtually all of the postings here, noting several categories they fall into.
Many, understandably and quite legitimately, are focused on short-term trading gains. Buy some shares low, hold for a time, then sell high. Take a profit, and turn back around and buy at a new low, and sell again at a new high. Day-trading, momentum trading, etc. For those here for those purposes, I wish the best. In the coming weeks, months, and years, AVXL should, as the investment advisories proclaim about good trades, “out perform.”
Others, however, see AVXL as purely a long-term investment, targeting greatly advanced share prices and rewarding dividends in the (maybe) distant future. I’m in this group (and one below). I don’t know a Fibonacci pattern from an Elliot Wave Pattern. The oft-posted technical analysis charts here are beyond anything I can comprehend or use. Glad those with technical analysis proficiencies post these. They can be useful for others with TA interests.
I base my AVXL investment purely upon Anavex fundamentals, the soundness of the company’s management and technologies. Whenever I can be useful, I post a message explaining the biology of Anavex molecules against neurodegenerative diseases. I would think the majority of readers and posters on this board are in this category, long-term AVXL investors aiming for substantial, future share-price appreciation and dividend returns. Typical “retail” equity investors, we.
But, lastly, there is a final category of reader here, with unique and personal interests, related to personal experiences with Alzheimer’s and other CNS diseases. I am in this category, too; as I have a mild but confounding case of Hereditary Spastic Paraplegia, a rare genetic condition that causes the adductor muscles of my legs to remain tight, spastic; complicating normal walking. A study was done (in France) where human genes of my condition were inserted into lab rats, and they, like myself, had difficulties walking normally. Then, these transgenic rats were given, orally, Anavex 2-73 (or a close proprietary analogue) and wonderfully, the rats began to walk normally. I’m a biologist and I have every molecular biological reason to believe that once Anavex 2-73 is available, I will take it and resume, at least to some degree, normal ambulation. Personally, that would be wonderful.
But on a more somber note, I watched my dear mother attempt to care for my father in his last five years, slowly declining and eventually dying of Alzheimer’s. The hope Anavex 2-73 holds for Alzheimer’s victims and their care-givers transcends (for me at least) any of the remunerative rewards of AVXL ownership. The prospect that, literally, millions can find both relief and prevention of Alzheimer’s, Parkinson’s, Rett Syndrome, amyotrophic lateral sclerosis, and a host of other neurodegenerative diseases (in addition to various cancers, heart diseases, and others yet to be treated) rises far above the monetary rewards I anticipate.
All of this enters the supremely social, even spiritual realm; where profound “good” is done for multitudes who would otherwise suffer so horribly. I’ve seen that suffering in the last years of my father’s life. I am encouraged by the solid science of Anavex, the company’s management, and the many retail AVXL shareholders here who share these hopes.
For those who suffer, Godspeed, Anavex Life Sciences Corp.
Not aware of Anavex’s technologies or molecules? What kind of explanation is that for the collective and professed ignorance of conventional Alzheimer’s researchers?
Scientists doing research are obligated to scrutinize and closely examine ALL of the published data and papers related to the topics they are investigating. To fail to do so is profoundly unprofessional, even amateurish. In an hour’s reading of two or three Anavex technical papers any competent molecular biologist or neurologist can comprehend (as did I, and I have no such deep training) exactly how Anavex 2-73 is new, different, efficacious, and revolutionary.
The standard dismissing response, of course, is, “Well, we can’t latch on to any of that until a proper double-blind Phase 3 trial is published and accepted by the FDA.”
If it’s of any joy, those people are going to be left staring into blank microscopes and empty tissue culture plates when Anavex achieves its destiny.
"It appears that even an "A+ team of research experts" is motivated by corporate bias and won't be persuaded until they read about it on the front page."
Forget it. The "experts" who deny or denigrate the Anavex technologies are, in fact, profoundly threatened by them. They can't for a brief second or short uttered phrase give any credence to Anavex; that would invalidate their entire research careers, casting doubt on their personal importance in Alzheimer's research.
The entire Alzheimer's research world is frozen and bound to the "clear the waste proteins (A-beta, tau tangles)" as the only plausible remedy.
Of course, two decades of failures after multiple trials of a variety of molecules should cause intelligent, deep-thinking researchers to look elsewhere. But that's not the innate sociology of medical research. For two centuries (well, much longer than that, in fact) medical "experts" have chronically rejected new, transformative medical technologies.
That's the way medicine is: if it wasn't learned in med school, anything "new" must, from the start, be rejected and scorned. Medicine was at its highest level of development when the good doctor was in grad school or med school; anything after that, unless proven with a decade of actual use, must be held in professional contempt — for the safety of the patient, of course.
Do a browser search of Ignaz Semmelweis, how he proved that physicians’ microbially-contaminated hands (from autopsies) infected pregnant women during physician-attended births, killing many mothers. Semmelweis came up with a revolutionary, transformative solution: wash one’s hands thoroughly before assisting in childbirth.
The medical community’s response? Just like the professional Alzheimer’s researchers: “That can’t work. That hasn’t been proven. We know what we are doing. We are the experts.”
And, it took several decades (well, almost half a century) after Lister and Pasteur for medicine to believe that germs cause disease.
For me, because I have biological training and understand, to a useful degree, at least, the molecular mechanisms by which Anavex 2-73 restores neuron homeostasis (the re-connecting of mitochondria and endoplasmic reticula, etc.) the abject refusal of the Alzheimer’s experts to even consider Anavex therapies is plainly criminal. Every single one of those researchers, were they to read, with an open mind (perhaps impossible) the multitude of technical reports on Anavex 2-73 would understand and grasp how the molecule works in the neuron much better than I. There is nothing magical or obscured about Anavex technology. It’s just entirely different from anything the researchers learned about in grad school, med school, in the clinic, or in their labs.
They are not willing or interested in learning anything new. Their careers are thoroughly vested in the always-fails clear-the-wastes treatment motifs.
"myelin is not a cell in and of itself...it is a projection of the oligo. "
"oligo-" means few or scant
"It says right there that it covers cytodegenerative diseases....cancer is not a cytodegenerative disease, MS is. Cytodegneration is dsctruction of the myelin sheath on nerves."
Actually, cancer is a cytodegenertive disease.
"cyto-" means "cell"
"-degenerative" means to degenerate, or decline to function
"Demyelination" is the loss or destruction of the myelin or insulating sheath on the outside of nerves.
Yes, perhaps early off-label use of Anavex might propel the drug to widespread usage.
What if a few physicians and their patients arrange for off-label use of Anavex 2-73, and, miraculously (well, understandably) early-stage Alzheimer's patients get slow but clear symptomatic relief.
This gets reported in local papers, etc. It's a story that non-medial media want to report; finally, some successful treatments for Alzheimer's.
Then, people start asking their doctors for Anavex 2-73 prescriptions for their parents, for which they are care-givers. The word is out: Anavex 2-73 really does bring symptomatic Alzheimer's relief, the FDA notwithstanding. Congressmen get hundreds of letters asking why the drug isn't widely available.
Trump and his new FDA head start bending and braking old FDA rules, and the drug exploads across multiple markets.
Let's see if anything like this occurs.
I have no useful experise regarding off-label prescriptions.
I think it will be possible (once approved and available for Rett Syndrome).
Two complications, perhaps.
First, many physicians will simply stay away from early off-label prescriptions because of medical tort laws and medical insurance. Untoward outcomes opens the doc up to zillions of dollars of liability.
Secondly, off-label prescriptions not covered by insurance; so expenses for such will may be sky-high.
In honesty, I do not know enough organic chemistry to detail the minute (but important) structural differences between the Anavex 2-73 and Anavex 3-71 (previously named AF710B) molecules.
But those arcane structural chemical differences are irrelevant to any Anavex investor. Important only to the organic chemists that will be synthesizing the molecules and the neurochemists who will be conducting detailed cellular therapies with them. That’s not us.
(Note below the two words “potentially” were underlined by Anavex. This is in delicate conformance to SEC rules, where a company cannot make incompletely-substantiated or promotional statements about their products. For some (the SEC, many financial “advisors”) the profound efficacies of either Anavex 2-73 and Anavex 3-71 are as of yet not sufficiently substantiated; hence, the feeble adverb “potentially.”)
Regardless of SEC rules, both of these molecules have profound scientific substantiation; first in animal (rats and mice) models of the central nervous system diseases Anavex is targeting, and now with the early Anavex 2-73 human clinical trials in Australia, profound human efficacies are known.
Those who for either investment tepidness or biochemical ignorance wish to wait for more substantial clinical results are welcome to do so. As a biologist I’ve scrutinized dozens of pages of technical papers on the Anavex pipeline drugs, and I have no doubt that a) FDA approval of Anavex 2-73 will be forthcoming for both Rett Syndrome and Alzheimer’s (with others to follow), and b) Anavex 3-71 presents efficacies for Parkinson’s Disease. Clinical trials will reveal those in humans, when conducted.
Note the number of Anavex pipeline drugs, here:
http://www.anavex.com/pipeline/
For us retail AVXL investors, here’s what we really need to know (copied from the Pipelines page of the Anavex website).
Anavex’s summary of Anavex 2-73:
ANAVEX 2-73
ANAVEX™ 2-73 is an orally available drug candidate developed to potentially modify Alzheimer’s disease rather than temporarily address its symptoms. It has a clean Phase 1 data profile and shows reversal of memory loss (anti-amnesic properties) and neuroprotection in several models of Alzheimer’s disease.
Successful Phase 1 Clinical Trial
A Phase 1 single ascending dose human clinical trial of ANAVEX 2-73 was successfully completed in healthy human volunteers. It was a randomized, placebo-controlled study. Healthy male volunteers aged 18 to 55 received single, ascending oral doses over the course of the trial. The trial objectives were to define the maximum tolerated dose, assess pharmacokinetics (PK), clinical and lab safety.
Results:
– Dosing from 1-60 mg.
– Maximum tolerated dose 55-60 mg; above the equivalent dose shown to have positive effects in mouse models of Alzheimer’s disease.
– Well tolerated below the 55-60 mg dose with only mild adverse events in some volunteers.
– Observed adverse events at doses above the maximum tolerated single dose included headache and dizziness, which were moderate in severity and reversible. These side effects are often seen with drugs that target central nervous system (CNS) conditions, including Alzheimer’s disease.
– No significant changes in blood safety measurements.
– No changes in ECG.
– Favorable PK profile.
– Rapid absorption into blood.
– Dose proportional kinetics.
***********
Anavex’s Summary of ANAVEX 3-71
ANAVEX 3-71, previously named AF710B is a preclinical drug candidate with a novel mechanism of action via sigma-1 receptor activation and M1 muscarinic allosteric modulation, which has shown to enhance neuroprotection and cognition in Alzheimer’s disease. ANAVEX 3-71 is a CNS-penetrable mono-therapy that bridges treatment of both cognitive impairments with disease modifications. It is highly effective in very small doses against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also has beneficial effects on inflammation and mitochondrial dysfunctions. ANAVEX 3-71 indicates extensive therapeutic advantages in Alzheimer’s and potentially other protein-aggregation-related diseases given its ability to enhance neuroprotection and cognition via sigma-1 receptor activation and M1 muscarinic allosteric modulation.
Cardiovascular Diseases to Cost One Trillion Dollars
New report:
https://www.eurekalert.org/pub_releases/2017-02/ri-cdc021417.php
If Anavex pipeline drugs have cardiovascular efficacies (murine data so indicate), ponder the market implications.
Yes, I read that report.
Presently, I don’t see much connection to or application of Anavex molecules, which we’d hope could suppress enervation of cancer masses. No evidence, just yet, for that.
Nonetheless, the multitude of efficacies and applications for the many drug candidates in the Anavex pipeline are enormous.
Understandably, and appropriately, we presently focus on Anavex2-73 in the suppression or reversal of Alzheimer’s symptoms. But therapy for Rett Syndrome is closely approaching; and I’m certain others will follow.
I’ve contended this before — Anavex therapeutic technologies will transform 21st-century medical care even more than antibiotics did in the last century. Aging and geriatric diseases may be well-controlled by our emerging company. Cancers are not out of the question.
"Homeostasis" really means "normalization."
Normalized cells don't divide or metastasize.
Just under a half percent (0.047%) of outstanding FSNR shares have traded today. (92 million outstanding shares, 434,050 traded so far)
Over $30,000 in FSNR trades today, in one or two trades total. Why would anyone buy $30k of these shares today? Pondering minds ponder.
"Not sure what you see as unique. AVXL has never explained whey their sigma 1 agonist is somehow more useful or has a different mechanism of action than the many others on the market (including Aricept). "
The reason you do not see what is unique about Anavex 2073 is that you don't know cellular biology, enzymatic control of reactions, and a host of other essential topics. There are not "many others on the market" that have any usefulness beyond a few weeks or months of symptomatic stabilization, afterwhich symptoms resume activity toward death. And none of those drugs work like Anavex2-73. Utterly unique.
You are making the mistake of so many others: presuming that Anavex2-73 works like and is similar to Aricept and the other few Alzheimer's treatment drugs, along with the many that have been tested and didn't work.
Be clear. There is no comparison between Anavex2-73 with anything formerly tested (and failed) and anything that's on the market now for Alzheimer's.
And yes, Anavex HAS explained, in molecular detail, how their drug acctually works in the Alzheimer's-affected neuron. But it's "brain chemistry," beyond the comprehension of those without biological training or knowledge.
Those, in ignorance of the precise and unique neurochemistry of Anavex 2-73, are welcome to lump Anavex with the multitude of previous Alzheimer's therapies.
Those of us with biological training know otherwise, that the unique, proprietary chemistry of Anavex 2-73 and its ability to re-connect endoplamic reticula with mitochondria is both effective, and unlike any other Alzheimer's treatment approach.
Anavex 2-73 is not a molecular crap shoot at the Alzheimer's casino, hoping against demonstrated hope that somehow Anavex2-73 might bring some syptompatic relief to a portion of Alzheimer's victims.
Nothing like that at all. The Anavex molecular biochemists know exactly how and why Anavex2-73 will be the eventual Standard of Care; how it actually can prevent and suppress Alzheimer's symptoms.
Yes, of course, there have been dozens of Alzheimer's therapy failures, and they have all tried to clear amyloid and tau waste proteins. Never works. Anavex attacks Alheimer's successfuly at the root cause, the dissociation of the mitochondria from the endoplasmic reticula. When they are connected, nerves work normally, clearly wastes normally. No other company has this technology; no other company shall reap the financial rewards of successful prevention and/or treatment of first Alzheimer's, then all the other diseases and conditions I mentioned, addressed by Anavex pipeline drugs.
Anavex is unlike any of the other drug companies. They have molecules that actually bring relief --- worth hundreds of billions in the coming decade.
"A BO @ $3 B will mean $75 per share which is 14 bagger at todays price.
Why not?"
Because the long-term, continuing value of Anavex is many multiples of this.
A fair value must consider existing treatment costs of those with Alzheimer's, Parkinson's, MS, ALS, several others, plus cardivascular, psychiatric, and cancer diseases --- all of which can be successfully treated (at least to a degree, beyond anything existing) by drugs in the Anavex pipeline.
Careful diligence cannot yet render a full value of Anavex Life Sciences Corp. Dr. Missling is aware of his company's future valuations, and isn't going to go for any quick billion.
Please explain:
"Exactly...Anavex and the head of the Trial have stated exactly why they aren't specifying anything...it needs to be proven in a larger trial."
Needs to be "proven," or replicated?
A "needs to be proven" explanation presumes error or inaccuracy with the existing data. Are there any reason(s) the existing trials data could be erroneous, or inaccurate data could have occurred?
The usual explanation, of course would be the absence of placebo arm, where statistically identical patients got a sugar pill they thought was the trial drug. The placebo effect could then cause diverse artificial efficacies.
But there is no evidence whatsoever the placebo effect can suppress the measured outcomes of Alzheimer's for any period. It degeneratively progresses no matter what. Consequently, existing, known symptomatic progression plots can be the comparison against which the Anavex 2-73 treatment data can be compared.
I'm betting it was corporate lawyers, in consideration of FDA and SEC rules and precedents, who advised Missling to give the "gotta do some more testing" response. He knows better. He saw all the data, both pre-clinically in animal models and subsequently in the human trials. Nothing like them in 25 years of Alzheimer's treatment research.
The "we gotta test this, now big time" notion, keeps financial tort lawyers, the SEC, and FDA all at bay. Each is eager to pounce on this so-disruptive and potentially un-ethical or fraudulent drug start-up.
Anavex, in some regards, is like a drug industry Donald Trump; saying (or implying) things that aren't stated within the drug corporate culture. Anavex appears (accurately) to have come into town to "drain the swamp" that swallows every other Alzheimer's treatment investigation. After doing so — perhaps with the "gotta test it now big time" phase 3 trial completed — it becomes clear Anavex then owns the entire Alzheimer's treatment game. Billions upon billions
Just over the hill is another swamp, where Parkinson's Disease treatment efforts slink into the mud. I won't be surprised if approval of an Anavex drug for this disease encounters the same, often mysterious confounding forces and factors.
The light of truth is appearing to the public, with full brightness when the FDA finalizes approval for Anevex2-73 to treat Rett Syndrome girls and women.
With that, the game changes to a much larger venue, with writers and announcers compelled to present more accurate data.
Gonna be fun.
I, too, was initially perplexed by the failure of Anavex to more precisely and clearly highlight the many positive data points and data sets in their trials results. They were presented, but mentioned flatly, almost only in passing. For example, the Aavex 2-73 trials data so clearly exceed any current Standard of Care modalities, but little was made of it.
Of course, should the existing SoC data be exceeded, coupled with the uncontested profound safety data, FDA approval would be mandated.
And that, I presume, is the rub.
I'm no lawyer, and know little of the actual legal factors at play; but it appears to me that Anavex Life Sciences Corp. is being very careful to ever approach statements of profound efficacy. In passing, tell the only numbers, and then move on to a new topic.
I'm betting that the Securities and Exchange Commission has a pile of arcane restrictive regulations on this, to a) keep companies from overly influencing the FDA, and/or more importantly (most likely) b) to prevent companies from pumping their un-approved drugs to retail investors. The data sets notwithstanding, Anavex 2-73 is not FDA approved. Allowing companies to say anything more than to mention raw data points in clinical trials results would allow the deception of ignorant retail investors.
I'm betting that Herr Doktor Missling has been thoroughly briefed by corporate lawyers on how to deal with, and present, the profound clinical trials results. Statements beyond mere numbers, with the simplest representative interpretation, open the company up to all sorts of lawsuits. That's last thing needed right now.
Missling knows far more than we about the world-changing prospects of the Anavex pipeline --- but hardly a word about it. We know better, as I and so many others can spell out in this public forum the authenticity of Anavez's phenomenal future.
Lawyers; don't ya love 'em? They're keeping us safe.
I have no useful knowledge of CTE/TBI beyond the symptoms and progression of the conditions.
As noted, things progress toward declining cognition, much in the manner of Alzheimer’s. I would therefore conclude that as with Alzheimer’s, CTE involves a physical disconnect between the mitochondria and rough endoplasmic reticula.
But here, unlike with Alzheimer’s, the affected individuals are in early adulthood, athletes in their 20s. Symptoms may not appear until later, in the 30s. “Worn out neurons” cannot be an explanation of cause.
Could the physics of repeated trauma disconnect the two organelles? Perhaps (I don’t know, however).
Or, could the severe trauma events cause inflammation that complicates or interferes with
normal brain function?
The actual root cause of the brain dysfunction is not important. Finding a treatment is; and because the symptoms of CTE are so similar to Alzheimer’s there is every reason to believe Anavex 2-73 would be effective.
My perusal of the information on CNS diseases suggests that those with Alzheimer’s-like symptoms universally involve the mitochondrion-endoplasmic reticulum disconnect; thereby amenable to Anavex 2-73 treatment.
The “firetrucks” analogy may be a bit overdrawn. Clearly, no “fire alarm” goes off when the neuron fails to produce normally-folded, fully-functioning enzyme proteins. Diminished neuron function proceeds.
But all of that is of no real concern with how Anavex 2-73 functions to restore homeostasis. Simply, Anavex 2-73 reconnects mitochondria with the rough endoplasmic reticula, allowing useful transfer of adenosine triphosphate (ATP) made in the mitochondria to the rough ER, where this cellular energy source facilitates normal and proper protein (enzyme) synthesis. The resulting properly-folded enzymes then effectively control normal cell chemistry (disease-free).
The reasons for sigma-1 receptor dysfunction are not clear. But, importantly, neurons must function throughout the life of the organism. Hence, the central nervous system diseases Anavex 2-73 treats are (mostly) geriatric; diseases typically with late-in-life onsets. With age, neurons wear out and function ever more poorly.
Anavex 2-73 restores normal neuron functioning — homeostasis — present at the person’s youth or young adult age levels.
Jimmy, I've been there.
My father, a formerly brilliant public accountant, was struck by Alzheimer's.
Nothing we couild do but watch him descend for his last five years to the continuing hell that finally took his life.
My mother, an experinced geriatric nurse cared for dozens of Alzheimer's patients. But trying to make things comfortable for her lifelong mate was overwhelming. Dad mentally and physically rotted wasy for two years in an institution. We would visit, be he kneww none of us.
Finally, he past, a blessing to everyone.
The article rather clearly lays out what is (rather authoritatively) known about the importance of sleep — it causes neurons to dissemble excess new synapses where memories are stored. Too many of these new synapses overwhelm normal cognition and memory.
Others have presented evidence that sleep, also, allows the clearance of waste proteins (such as amyloid plaque and tau tangles) produced by normally-functioning neurons.
https://www.nih.gov/news-events/nih-research-matters/how-sleep-clears-brain
All of this supports the homeostasis-restoring outcomes of Anavex 2-73. In normal brain cells, a night’s sleep allows the enzymes of the neuron to mobilize and transport the excess wastes and extraneous new synapses to the exterior, never allowing them to accumulate. But, because the rough endoplasmic reticula become separated from their associated mitochondria in the Alzheimer’s disease state, the rough ER can’t make or properly fold normal waste-clearing proteins (specific enzymes). Normal cell clean-up is fatally disrupted.
Alzheimer’s patients can sleep for extensive periods, with no cognition improvements. If the health-giving protein (enzymes) are not made, amyloid and tau proteins will accumulate, disrupting normal neuron functions.
Let me add this.
All of this is abundantly clear to all parties involved in any potential Anavex collaboration. This may be deep cellular chemistry (inscrutable “brain chemistry”) to both retail AVXL investors and stock consultants.
But the principals involved in any potential collaboration know full well the profound efficacies and CNS disease applications for Anavex 2-73. They have or are brain biochemists. They’ve scrutinized the many application reports in murines (rats and mice), and know how those can be accurately interpreted to apply to Homo sapiens.
Projecting an announcement of a corporate collaboration is more complex than either stock charting or knowing the details of intracellular neuron biochemistry.
That’s gonna happen behind closed doors, with no one on the outside even knowing the matter is in discussion.
It’ll happens when it happens. I have no expertise that tells me when.
Just watch and wait.
I marvel at the complicated chartwork several posters here promote.
Fibonacci numbers. Elliot Wave theory. 200 and 50 day moving averages. Resistance and Support levels. So much more — none of which is usefully understood or applicable for me.
On my side, as a biologist, I understand equally complex intra-cellular reaction pathways of the molecules Anavex 2-73 can control as it restores normalized cell chemistry.
A good chartist could spend a few hours explaining to me the validity and usefulness of the arcane world of stock charts. At the end, I would be only confused.
Likewise, I could spend a few hours charting out (as it were) the normalized molecular pathways in the neuron that Anavex 2-73 so wonderfully restores. But unless one had an extensive background in neuron chemistry, my lessons would be equally confusing, providing no useful perspectives on the unique restorative reactions facilitated by Anavex 2-73.
Because of all of this, I presume the daily AVXL price ranges will continue to move along as they have: up some, down some, etc., with no breakouts in either direction.
As I see it, the only thing that will push a substantial price rise will be news of some sort of Biogen (or other pharmaceutical) collaboration. For those ignorant of both charting and neuron biochemistry (the vast majority of potential investors), an announcement of corporate collaboration will, finally, verify the Anavex story.
Where the share price goes after that is unknown. I’ll just sit back, and watch. I’m not interested in selling any AVXL shares at any time. I’ll just delightfully cash my quarterly dividend checks.
The real impact of Anavex 2-73 (and later, Anaves 3-71) will be their prophylactic --- disease prevention --- uses.
Right now, everyone is focused on Anavex treatment of existing, early- or mid-stage Alzheimer's patients. Granted, their successful treatment, where symptomatic progression is either halted or reversed, would be wonderful.
Herr Doktor Missling aluded to eventual prophylactic therapies, implying, as I recall, of efficacy in murine (rat and mouse) models of CNS diseases.
With that, the market for Anavex drugs will be gigantic, far beyond the few million suffering from Alzheimer's or Parkinson's. The stuff has no side effects, so it can be prescribed prophylactically with only good results.
Then, note that Anavex pipeline drugs have potential efficacies against cardiovascular dieases, cancers, psychiatric conditions, and who knows what other conditions and diseases that will eventually be discovered to favorably respond to Anavex therapies.
The sigma-1 receptor is present in almost all cells, used to create normal-functioning homeostatic conditions in the cell. I contend we don't know yet all of the diseases and conditions the Anavex sigma-1 receptor agonists will successfully treat.
As I've contended before, the Anavex revolution in medicine will be far greater than the antibiotic revolution in the 40's and 50's.
In ten years, medicine is likely to be very different from today.
Make Your Posts More Readable
I do a lot of technical writing, often for public blogs and sites such as this one. Those who have read my postings note that they are easy to read through. But too often (well, almost always) postings here are just long, compressed single paragraphs. Writers here too often fail to break up their postings into sentences and separated paragraphs. The information presented is all good and fine; but the failure to hit the return key, to create a new, separate paragraph detracts from the information and makes it hard to comprehend. So, try to use the enter or return key, often. Don’t post any paragraph longer than three or four sentences. Create paragraph spacings. Important sentences can be a single, separate paragraph. We are not writing on paper here; we can take as much space as we need to make things easy to read.
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The paragraph above is all bad, violating each of the procedures to make the information clear. Here’s how it should be presented:
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I do a lot of technical writing, often for public blogs and sites such as this one. Those who have read my postings note that they are easy to read through.
But too often (well, almost always) postings here are just long, compressed single paragraphs. Writers here too often fail to break up their postings into sentences and separated paragraphs. The information presented is all good and fine; but the failure to hit the return key, to create a new, separate paragraph detracts from the information and makes it hard to comprehend.
So, try to use the enter or return key, often. Don’t post any paragraph longer than three or four sentences. Create paragraph spacings. Important sentences can be a single, separate paragraph.
We are not writing on paper here; we can take as much space as we need to make things easy to read.
Just watched the presentation.
Everything --- and more --- that I have perceived about both the company and the drug.
There is no doubt that FDA approval for Anavex 2-73 will be forthcoming, perhaps sooner than expected.
If ever there were a drug for which expedited approval is warranted (under President Trump's new facilitated approval process), this is it.
Complete safety, with remarkable efficacy.
Wish I had some funds to increase my AVXL position.
"So which is the cause of amyloid buildup - failure to cleanup a-beta after its been formed, or misfolded enzymes producing a-beta in the first place?"
Misfolded enzymes keep the neuron from clearing the amyloid and tau wastes. Waste protein clearence occurs in healthy neurons, where mitochondria are properly connected to rough endoplasmic reticula. When the mitochondria separate from the rough ER, waste-cleariing enzymes are not produced.
Anavex 2-73 reconnects the mitochondria and rough ER, restoring healthful neuron homeostasis. The properly folded enzymes then are able to clear (or at least prevent the accumulation of) amyloid and tau waste proteins.
Here's a new research article on misfolded proteins (enzymes).
https://www.eurekalert.org/pub_releases/2017-01/uoc--oot013017.php
This doesn't deal with misfolded enzymes that cause deposition of amyloid and tau proteins --- but the aberrent mechanisms are the same, where endoplasmic reticula fail to properly function.
Anavex 2-73 re-connects mitochondria to rough endoplsamic reticula, allowing them to properly fold proteins into healthful enzymes (using the ATP produced in the mitochondria).
Bryostatin has promise.
But from reading this announcement (http://www.news-medical.net/news/20140819/Study-shows-bryostatin-plays-key-role-in-slowing-or-reversing-Alzheimers-disease.aspx) I don't see that it can in any way eclipse Anavex 2-73.
Some bold claims are made, that bryostatin can restore snyapses, etc.. Well and good, but I could find no murine tests that are as affirmative as those with Anavex 2-73.
Side effects are not mentioned; may be a diminishing consideration.
I'll maintain my AVXL position.