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Not known yet --- but probable.
Will 2-73 reverse severe and moderate Alzheimer's?
Don't know or follow "Seeking Alpha."
Have you considered writing an article about Anavex on Seeking Alpha?
Those who need to know, know.
I thank several posters for their commendations of my descriptions of the efficacy and safety of Anavex technologies (proprietary molecules) for the eventual successful treatment of neurodegenerative diseases. I'm honored to be able to helpfully tell the powerful Anavex story here. I have rather extensive science writing experiences, and I'm a retired advance-placement biology teacher. I understand the fundamentals of the otherwise complex biochemistry of Anavex drugs, and, to a degree, can explain them to interested audiences.
Importantly, none of the arcane cellular and chemical processes of the Anavex drugs are hidden, mysterious, or un-comprehended by those who need to know. Of course, all of the Anavex principals know the details. But, so now do FDA and potential pharmaceutical collaborators and support groups. All of this may continue to be mystical to common retail equity buyers, institutional buyers, and financial advisors. But none of them will play any roles in Anavex's future successes. Those who know the story will guide its successful conclusion.
Will make Anavex an even bigger success.
:...it is a bit reassuring that other researchers are realizing that there is commonality with the various degenerative diseases: AD, PD, HD, etc.
More of the same, a last century approach.
That article tells the same, failed Alzheimer's treatment story: accumulated waste proteins in neurons cause Alzheimer's symptoms, therefore, the only viable treatment approach is to find some way to extract those wastes.
In fact, Anavex has such a way. Instead of trying harsh chemicals or externally-forced immune responses, all of which have failed, Anavex fixes the problem at its source, at the beginning of the Alzheimer's disease process, not at it's end.
The researchers haven't asked or addressed the real problem: what causes the toxic accumulation of the protein wastes, the beta-amyloids or tau tangles? Instead, they focus on trying to get rid of the wastes after they've accumulated, and will continue to accumulate while the root-cause of Alzheimer's goes untreated.
The root cause is NOT waste protein accumulations. It's the progressive dysfunction of the mitochondrion-endoplasmic reticulum complex. Alzheimer's, along with virtually all of the other geriatric neurodegenerative diseases, is caused by mitochondrial dysfunction. Mitochondria synthesize adenosine triphosphate, ATP, which is the energy-providing molecule for virtually all cellular reactions and processes. Normally, ATP is passed from the mitochondrion to the attached rough endoplasmic reticulum, a layered membrane that, with enough ATP (and other molecules and ions) allows proteins to be properly and precisely folded into fully-functioning enzymes. Some of those enzymes remove and/or degrade normal cell protein wastes, including the neurotoxic beta-amyloids and tau proteins.
In Alzheimer's, the rough endoplasmic reticula become detached from the mitochondria, so they don't receive sufficient ATP. Protein folding is compromised, and waste-clearing enzymes are poorly produced. Toxic protein wastes accumulate, disease symptoms appear.
That's the root cause of Alzheimer's, and Anavex 2-73 effectively, efficiently, and safely re-connects the two organelles, Waste-clearing enzymes are produced once again, and over time (weeks or months, it appears from early clinical results), normal neuron health is restored.
Why, then, do so few Alzheimer's researchers and institutes fail to make this so-sensible approach? Very simple. They know of none, nor have any molecules that can do this. Anavex Life Sciences Corp is the sole proprietor of this revolutionary technology. An independent Alzheimer's research scientist can't place an order for 500 mg of Anavex 2-73 from any chemical supply firm. Anavex owns and develops the molecule and its several important analogues.
The Alzheimer's treatment and prevention game is entirely in the Anavex labs and clinical trials. No one in the business can even imagine how to replicate the process. The clear-the-wastes approach will continue to be the proclamation (as in this article) until Anavex's stunning P3 results shake the Alzheimer's research world.
Superior Anavex management team.
For viewers distressed at the apparent lack of favorable corporate announcements, for those who might tend to believe that corporate officers simply aren’t doing or accomplishing anything, I suggest a detailed reading of the accomplishments of each of the Anavex board members, here: http://www.anavex.com/about-us/management_directors/
Are any of these distinguished fellows the personality types to sit back in their office chairs, prop their feet up on their desks, and argue about some sports team or otherwise waste time?
None of these fellows got to where they are by laziness, lassitude, inattention, or neglect. Each is markedly distinguished and accomplished. Only one, Mr. Skarpelos, fails to have any distinguishing letters behind his name. All he has is a career with various biotech companies and ample financial resources. He’s the biggest Anavex shareholder. It’s in his self-interest that the company succeed.
Not a one of these fellows is failing. In time, we will see the results of their management and development diligence and expertise. Profoundly qualified, each.
Anavex to be a business school case study.
As slow and disguised as corporate developments appear to be, I'm certain that big things are being arranged and are happening behind closed Anavex doors. Herr Doctor Missling and his every-growing body of drug development experts simply are not sitting around twiddling their thumbs, awaiting some external things to happen.
No, the Anavex principals have world-class status and know that at this stage the most important efforts are to get the Anavex picture framed and lighted, for eventual revelation to an appropriate corporate world, the complex of Big Pharmaceuticals, along with supportive and collaborative interest groups (Alzheimer's, Rett Syndrome, Parkinson's support groups, etc.).
All of this has to be done effectively --- and that's not (yet) in the public forum. All matters must first be arranged privately with appropriate parties --- and none of those are we retail Anavex equity investors. For now, we are not in the picture. Our days will come, when Missling et al. have constructed effective corporate collaborations and regulatory approvals.
I contend that, in time, the Anavex story --- how this company revolutionized 21st-century medicine --- will be classic and required reading at all business schools. How could a small group of scientists, with a collection of new molecules cobble together a fully-functioning new Big Phrama company that a) solves so many medical problems, b) reaps great rewards for shareholders, c) saves governments billions upon billions of dollars of health care costs, and d) improves the lives of countless individuals across the world?
All of us here get to watch this story as it slowly (but rapidly, in time) unfolds.
Sleep a factor in Alzheimer’s severity.
New technical report implicates sleep deprivation as a cause or contributor to Alzheimer’s disease. “...research has found that chronic sleep deprivation increases so-called plaques in the brain thought to be a main cause of Alzheimer’s and other dementias.”
Anavex 2-73's suppression of insomnia (apparently universal in the Australian trial participants) may be more than a merely useful go-to-sleep outcome. Sleep, itself, may suppress the onset of Alzheimer’s. Middle-aged insomnia may tip things ominously in the direction of Alzheimer’s. Suppression of insomnia may be but yet another favorable mechanism for Anavex 2-73 against Alzheimer’s.
http://www.telegraph.co.uk/science/2017/05/26/sleep-deprivation-can-cause-brain-start-eating/
Multiple Sclerosis involves demyelination, where the malfunctioning immune system attacks insulating nerve tissues, the myelin sheath, allowing nerve impulses along the nerve to leak out. Like removing the insulation on an electrical wire. Nerve signals "short out."
And, yes, this (as with so many other disease processes) is a form of inflammation, where the immune system attacks normal, good body tissues.
MS therapies attempt to turn down the inflammation, turning down the immune system. But with that, infections and other untoward outcomes can proliferate.
Inflammation a factor in almost all diseases.
Yes, inflammation is a component of most CNS diseases. In fact, 21st-century medical science has come to the conclusion that inflammation, in one form or another, is involved with the vast majority of diseases and conditions.
Whether or not Anavex molecules might rather directly control or suppress such inflammation is unknown to me. I don't recall any such outcomes or references in the good number of Anavex technical papers I have perused.
That's not to claim any Anavex inflammation inefficacy; merely to state I've don't recall any references to the matter.
This does raise the question, however, what new, other diseases and conditions might Anavex molecules treat? Some time ago, the only target disease I was aware of was Alzeimer's. Now, Rett Syndrome is a prime target, closely followed by Parkinson's and other CNS diseases.
We've already conjectured on how Anavex 2-73 might well prove to be a remarkably safe and effective treatment for insomnia (with strong supportive evidence in the Australian trial).
In the Anavex pipeline webpage, there are indications or conjectures that Anavex molecules will treat cardiovascular conditions, psychiatric conditions, and cancers.
The spectrum of Anavex efficacies is yet unknown, but clearly wide.
With a lengthy, large-n Phase 3 Alzheimer's trial (later this year) all sorts of non-target, incidentally good outcomes may be discovered beyond just Alzheimer's symptoms (as were the insomnia results in the P1/P2 Australian trial).
No Technical Analysis
I note with curiosity (but no significance) the recent absence of Anavex TA charts and projections. Not sure (nor don't care) what this means.
AVXL continues to trade in narrow range. I would expect more of the same until substantive corporate news appears. (But I'm a biologist, not a chartist or trader, or anything of the kind.)
No indication I know for Anavex against arthritis.
I haven't seen any technical reports or other information that any of the Anavex molecules might effectively treat any of the various forms or causes of arthritis.
Perhaps this will incidentally show up in future clinical trials for target conditions (Alzheimer's, Parkinson's, et al.).
Given the profound, demonstrated efficacies against so many conditions, it's not inappropriate to hope Anavex may someday have another answer to yet another debility.
So, the tau tangle thing again (any different?).
Merck, perhaps in desperation, collaborates with a Japanese pharmaceutical pursuing a tau protein removal drug. Good luck with that one. How many other Big Pharmas have spent billions testing both beta-amyloid and tau tangle removal drugs? Not a one has been successful in any way.
If this one can work, fine. Chances are slim, however. I'm not buying any Merck shares.
Once again, the target is an end-stage outcome. Beta-amyloids and tau tangles result at the end of the neuron dysfunction processes that cause Alzheimer's. This is where Anavex is so superior. It's drug, Anavex 2-73 treats the initial, first-stage problem, the disruption of the mitochondria-endoplasmic reticula interface. In normal, homeostatic neurons, the mitochondria are attached to the endoplasmic reticula and easily transfer adenosine triphosphate (ATP) to the ER, which allows it to properly fold proteins into fully-functioning enzymes, some of which clear the waste proteins, beta-amyloids, and tau tangles.
Anavex 2-73 fixes things before wastes accumulate, right at the start of the disease process, not the end. No other drug in consideration can do this. Unique, safe, and effective. Anavex 2-73, the eventual Standard of Care for a multitude of geriatric diseases.
Looks favorable for Rett Syndrome
Thanks for the URL.
If the molecule (or analogues) work in afflicted humans as described, the drug looks to be very useful.
Appears that it will work best if administered early on, with Rett Syndrome right at birth, as the drug appears to best treat things during development. Therapeutic efficacy at later ages, when neurons and brain tissues are more developed, may be questionable.
The drug is certainly not a competitor of Anavex 2-73. It works very differently, affecting certain neuron molecules (cytokines, etc.).
One form of the molecule apparently can cross the blood/brain barrier (it can be orally administered). It also is claimed to have a longer half-life (resides in cells longer). All favorable.
But actual therapeutic outcomes, degree of healing, is not mentioned (and presently may not be known).
Hope this can work for Rett Syndrome patients. (I'll still restrict my investments to AVXL.)
Good question --- long term safety.
Falconer, in your opinion are we free and clear from all safety issues?
No mystery.
Does anyone know how they calculated the $17?
No, takes some developed biological knowledge to be able to understand the unique, revolutionary biochemical mechanisms of Anavex 2-73, all of which point to remarkable future successes.
The general market is, by and large, clueless as to Anavex biology. Therefore, no big share price increases until information appears that the general public can understand, such as approval or conduct of new clinical trials. Presently, there is nothing the non-scientific crowd can connect with to AVXL.
In time, the entire world will learn of the Anavex revolution. (But most of us here, will have been in early, persisted, and will reap great rewards.)
Targeting the root cause. It's not beta-amyloid.
The belief that Alzheimer's is caused by the aggregation of beta-amyloid plaques and neurofibrillary tangles is starting to get muddied and the "consensus" scientific opinion is no longer.
More positive Anavex developments.
The ability of Anavex 2-73 to safely, effectively treat an ever-expanding list of Central Nervous System diseases is further revealed by today’s corporate announcement:
http://ih.advfn.com/p.php?pid=nmona&article=74661505
Read the whole article. Count and list the number of CNS diseases for which Anavex 2-73 has shown efficacy. It’s not just Alzheimer’s or Parkinson’s.
I’ve done a bit of reading of technical papers investigating successful Anavex 2-73 treatment of animal-based analogues (transgenic, etc.) of human CNS diseases. That list is even bigger. Beyond CNS diseases are cancers, heart disease, psychiatric conditions, and more.
The safety and magnitude of Anavex 2-73 therapies (and later, perhaps equal or exceeding it by Anavex 3-71) are, as yet, virtually unrecognized by the general investment and scientific communities. Those communities continue to think Anavex 2-73 is but another, destined-to-fail beta amyloid target.
This willful ignorance, however, is not possessed by whatever parties Anavex principals are discussing with potential marketing collaborators. Behind closed doors, experts are fully aware of the revolutionary Anavex molecules, and will act appropriately. We don’t get to monitor those discussions, but the science and clinical data can be understood by a college freshman biology student. No real mystery; just new, unique, and unexpected facts.
And none of this is obscure to FDA officials monitoring Anavex’s progress. The Trump administration’s efforts to bring new drugs promptly to market set Anavex 2-73 in sharp focus, a perfect demonstration drug for this new initiative.
Let’s see how this plays out.
The seven dropouts issue.
As far as I can determine, there is no information telling why seven trial participants dropped out. There is no good reason to believe these drop-outs occurred because of adverse events, bad side effects, from Anavex 2-73.
People drop out of clinical trials for many reasons, unrelated to and unaffected by the drug being investigated in the trial. Remember, almost all Alzheimer's patients are elderly, open to any number of geriatric health conditions and problems, and of which (unrelated to Anavex 2-73) could prompt the decision to drop out of the trial.
In fact, I would think it to be required to report any trial drug-induced drop outs, drop-outs caused by trial drug-induced adverse events. I've seen no such reports. I presume, therefore, that the seven drop outs were for other reasons, not directly caused by Anavex 2-73. Those seven individuals do not, as I understand it, taint or question the trial's remarkably favorable low adverse incident rate. As the published trial data show, Anavex 2-73 is without any disqualifying adverse events. Side effects, when present, are relatively mild (headache, et al.) and do not complicate the drug's usage in any way.
The published data are clear. Anavex 2-73 is utterly safe when prescribed in the dosage ranges of the P1/P2 Australian clinical trial.
Safety and Insomnia Factors. Another Anavex 2-73 market?
The profound efficacy of Anavex 2-73 to effectively allow people with insomnia to resume normal sleep is, of yet, not properly factored into future AVXl values.
Two matters of demonstrated value:
A, Anavex 2-73 has proven to cause no disqualifying adverse events. Unlike almost all neuro-active drugs, it has no record of disqualifying side effects, as proven in the P1/P2 Australian clinical data. The stuff is utterly safe.
B, In that same clinical trial, it demonstrated universal, complete treatment of insomnia.
What, then, if Anavex 2-73 were to be proposed as a new prescription insomniac? Insomnia is a major public health issue, causing all sorts of untoward outcomes, at great cost. The market for a safe, effective treatment for this mental health scourge is gigantic.
Were that to occur, were it to come to market as an insomniac, might it be subsequently discovered that those treating their insomnia with the Anavex drug subsequently had reduced rates of CNS disease onset? (Incidental CNS disease prophylaxis?)
Never heard of the company.
Provide a URL, please (regarding anything associated with AVXL).
Clueless regarding the hard science.
Gone no where? Really?
Do you guys realize you have been discussing the exact same stuff for 1.5 years already and this has gone no where.
Been watching the trading range.
I’m no technical analyst, merely a common retail owner of AVXL shares (because I understand the revolutionary biology of the company’s molecules).
Appears to me that AVXL has traded sideways for a few weeks. No declining nor ascending trends. Would like to hear what the tech analysts think this means.
For me, it means that the majority of AVXL shares are now in strong hands, held by individuals and institutions looking beyond the regulatory and clinical results horizons, confident that future share prices (and perhaps dividend returns) strongly suggest long-term holds will be the most profitable actions with this equity.
I’m holding my shares, and will not cash out any until at least the high double digits. (And when share prices ascend to those lofty levels, new substantiating clinical results and other solid-science info might project or forecast 3-digit share prices.)
I’m pleased that there have been no persisting sell-offs into the 3- or 4-dollar levels. Again, seems that few shareholders want to liquidate. Presently, no cheap shares are being offered. The vast majority of AVXL shareholders now see that Anavex Life Sciences has a remarkable future beyond the near-term investment horizon. 2018 is going to be very interesting, very rewarding, I believe.
The recent FNSR trade volumes (in the hundreds of thousands) have been said to be “all a front.”
That is a perplexing explanation. What, specifically, is a stock trading “front.” I’ve been buying and selling equities for 20 years and have never encountered the term.
What is the “front?” Who creates it? How? Why?
At 12:37 EDT, 203,000 FSNR shares have been traded. The latest posted price is $0.0431. If that were the price of all of the trades, about $8,700 has been expended by buyers.
If Freestone is a worthless company, what, conceivably, would be the reason anyone would fork over $8k for 203,000 shares of a worthless, going-nowhere company?
The only plausible explanation I can conceive of is that someone has information that the company does have a viable future, worthy of an $8K bet; to play out handsomely in the future.
Again, explain the “front” thing. Makes no sense. Only plausible explanation is that someone thinks FSNR is worth an $8k position at these low prices.
Ok, I'm out of the options game.
Well, never was in, just tried to figure it out. Clearly, it's not for my personality type: rectilinear science, merely adding and subtracting numbers, watching plotted data sets. Risk determinations at the most elemental level.
I'll hold my AVXL shares; will take profits in the distant future, after great appreciation. I'll stick to what I know best, cellular biology and associated topics.
(And yes, were I to create a webpage telling the details of neuron chemistry, it would for many [well, most] be as arcane and inscrutable as the options game would be for me.)
Therein is the cause, I believe, of the narrow and horizontal AVXL trading range. Very few retail or even institutional investors can fathom the world-changing technologies in Anavex's arsenal. To them, Anavex is but another doomed-to-fail pharmaceutical start-up, with some hokey early phase data that cannot playout well in a real giant placebo-controlled double blind trial. They are certain of this because of the multitude of similar Alzheimer's drug Phase 3 trial failures.
But those good folks couldn't tell the difference between the secondary and tertiary structures of a peptide or protein, and how those apply to normalized enzyme function. Without such knowledge (in orders of magnitude greater depth) the unique significance of Anavex 2-73 (and later Anavex 3-71) cannot be usefully comprehended.
The only thing that will change AVSL share prices will be news of a financial nature from the company. We await such.
I'd love to watch an options expert operate.
With AVXL and few other equity positions, I'm a retail buy and hold guy. I've tried to learn the options game, but it seems too difficult; seems to be just a complicated way to lose money.
Would like to see every position taken, and more important, why. All the while telling us options novices the terminology. "Puts." "Calls" "In the money." etc.???
It appears that up to $10,000 were expended in today’s trade volume (168,436).
Who, in his right mind, would fork over so many dollars for such a worthless company?
No one with $10,000 laying around would.
Someone believes Freestone does have profitable future, worthy of an investment of this size; with a share-price payoff some time in the future.
We'd all like to know what prompted today's FSNR trades (there were apparently, only 2).
Alzheimer’s experts call for FDA Alzheimer's drug changes
The posting,”... recommends that the FDA approve new medicines that demonstrate a proven benefit on at least one therapeutic endpoint - either cognition or function. The current FDA standards require a new drug to show benefits on both proven endpoints, an unnecessarily challenging hurdle the authors say may be inhibiting investment in new Alzheimer's treatments.”
Additionally, this was stated:
The authors wrote that a modernized FDA standard for Alzheimer's medications would reflect changes in the field and in treatment since the 1990s, and it would also align with draft guidance issued in 2013 for drug development for early Alzheimer's. Specifically for Alzheimer's, the authors argue, if a new drug improves memory but has less positive impact on a patient's daily functioning skills, the medication should still meet standards for FDA approval, because clinically meaningful improvements in cognition matter importantly to persons with Alzheimer's independent of functional improvement and vice-versa.
Irrespective of the degree of impact on secondary measures, the notion that the FDA would deny approval for a safe and well-tolerated drug candidate that achieves its primary endpoint of improving cognition in patients with Alzheimer's disease is almost unthinkable," the authors wrote.
The authors emphasized that the new standard is essential at a time in which recent clinical trial failures on Alzheimer's drugs have adversely affected investment in disease research. The FDA has not approved a novel Alzheimer's treatment since 2003, and the 5.5 million Americans with Alzheimer's and their caregivers are desperate for innovation.
https://www.eurekalert.org/pub_releases/2017-05/apa-aec051117.php
The failure of yet another Alzheimer’s drug, Neurotrope’s bryostatin-1, might prompt some to find this in favor of Anavex Life Sciences, inasmuch as Anavex now has the only human trials data that solidly show authentic positive treatment results (to be more firmly established in an ensuing big Phase 3 trial). Neurotrope will not be an Anavex competitor.
Nonetheless, the failure of Neurotrope’s drug will do nothing for Anavex. The investment advisor community will, as before, site this as proof that no drug company, big or small, new or old, can offer any useful Alzheimer’s treatment drug; that investing in any company — such as Anavex — is a demonstrated fool’s game. A multitude of very expensive trials have failed, and so will Anavex’s, it will be contended.
The unique neuron biochemistry of Anavex 2-73 is beyond the comprehension of most advisors. They lump all Alzheimer’s drugs in the same category — requisite failures.
As in the past, I’ll suggest that AVXL share prices will trade sideways, in a narrow, static price range until new, hard clinical data are released some time in the distant future. Case in point is the market’s reaction to today’s hiring of a former FDA official. The implications of that are very positive, but the market discounts it.
AVXL is only for the patient — with stunning future rewards.
About the Standard of Care (SOC)
An important factor in any future medical uses for Anavex drugs (once approved by the Food and Drug Administration and available for prescription) will be the Standard of Care (SOC) mandate. It would be useful for Anavex investors to understand the meaning and application of SOC. We hope and believe Anavex 2-73 will eventually be the SOC for Alzheimer’s, dramatically eclipsing (and negating) any of the few Alzheimer’s drugs currently on pharmacy shelves. As most are aware, none of those provide continuing good results. At best, they merely suppress the severity of symptoms but for a short, limited period of time, from a few weeks to a few months; whereupon the symptomatic trend toward death resumes. Tragically, that’s the meager Standard of Care today.
What, then, is the definition of SOC? Very interesting — and very promising for Anavex Life Sciences and its shareholders (but even more so for Alzheimer’s victims).
Here is one website’s definitions http://www.medicinenet.com/script/main/art.asp?articlekey=33263 :
Standard of care: 1. A diagnostic and treatment process that a clinician should follow for a certain type of patient, illness, or clinical circumstance. Adjuvant chemotherapy for lung cancer is "a new standard of care, but not necessarily the only standard of care." (New England Journal of Medicine, 2004)
2. In legal terms, the level at which the average, prudent provider in a given community would practice. It is how similarly qualified practitioners would have managed the patient's care under the same or similar circumstances. The medical malpractice plaintiff must establish the appropriate standard of care and demonstrate that the standard of care has been breached.
This is not a rebuttal; a presentation of hard data.
Take the time, if you will, to ponder the copious data presented in this Anavex slide show, presented at a major neurological symposium:
http://www.anavex.com/my_uploads/CTAD-Anavex-December-2016.pdf
First (if you care not to read and comprehend the entire presentation), note the safety of Anavex 2-73, the absence of disqualifying or severe adverse effects, side effects, on page 16.
Then, skip to the chart on page 25, and note the restoration of measured cognitive function (electrochemically) on page 25.
No other drug or clinial trial has ever been able to reverse and/or restore normalized cognition in Alzheimer's patients. Anavex 2-73 did that --- without any of the severe side effects so common in neurological agents. That's the Anavex "story," and it's not fiction.
The seminal question here is, is the insomnia of Alzheimer's of a different cause than common insomnia?
I know of no evidence or reason to believe that Alzheimer's insomnia is unique, unlike any other. On this basis, I'd offer the conjecture that Anavex 2-73 will effectively treat most or all forms and causes of insomnia.
Only way to know will be to treat a broad spectrum of insomniacs, of course.
Another future clinical trial and Anavex 2-73 application?
The favorable insomnia outcomes of Anavex 2-73 in the Australian clinical trial have not been much considered. They should be. Should the drug prove to be a universal and safe treatment of insomnia in the upcoming Phase 3 clinical trial, the implications (to use a now-common phrase) will be H U G E. According to Wikipedia, “Between 10% and 30% of adults have insomnia at any given point in time and up to half of people have insomnia in a given year....”
What if a low dosage of Anavex 2-73 provides universal insomnia relief? Would there not be a chance that at first, the drug gets prescribed for insomnia, followed sometime later with over the counter sales?
This will be another useful determination of the big Phase 3 study.
I don’t believe the entirety of Anavex 2-73 clinical applications have yet been discovered.
Stunning. Nothing but last-century Alzheimer's perspectives.
Just read the webpage. Same old same old. Lots of failed tries to eliminate beta-amyloid plaques and tau tangles. Nothing close to success. Then, present Standard of Care (SOC) acetlycholinesterase inhibitors, yielding but a few weeks or months of symptomatic progression relief.
Is anyone wondering why AVXL has not markedly appreciated? Perspectives and understandings such as the author presents on this webpage pervade pharmaceutical commentaries.
Clearly, the mechanistic details, efficacy, safety, and applications of Anavex 2-73 are virtually unknown by the investment advisory community. What little (inadequately) is known is summarily dismissed as just another ensuing Alzheimer's treatment fiasco. There have been so many of those commentators fail even to take the time to learn the unique chemistry of the Anavex molecules. Poor reporting it is.
As I've contended previously, nothing much is going to change until Phase 3 data are released, showing in great magnitude all (and perhaps more) than the Phase1/Phase2 trial in Australia revealed.
The vast majority of investors invest on the basis of anticipated share price increases and dividend returns. The underlying, enabling hard science is unknown and/or irrelevant. We can lay out the science in the greatest detail here all we want. It will make no difference. Hard neuron science simply is, and will not, play any part in the AVXL share price. The reporting of drastically-decreased (or even just stabilized) symptoms in dozens upon dozens of the upcoming Phase 3 clinical trial will do the trick. Money can be reliably envisioned from such data.
Reasons Pharmacokinetics/Pharmacodynamics data are not being revealed is unknown to me.
I won’t speculate on this at all. It has nothing to do with whatever expertise I might contribute (reasonable, but not complete understanding of cellular chemistry and physiology). I will presume that Anavex is retaining the info for some presently inscrutable negotiations purpose, for some future corporate benefit.
I don’t doubt the data exist, nor that they are important. Why they are being retained is in the realm of financial negotiations, etc. Far beyond my ken. I try to stick only to the science of Anavex; nothing regarding share prices, etc.
But thank you for asking.
Rett Syndrome, no "h", no "'s."
To answer your good questions.
Yes, additional human trials are needed, for several reasons. A conventional double-blind Phase 3 study, with an experimental arm (with the real Anavex 2-72), and a control arm, where a physically identical placebo is administered is needed. FDA rules require such for eventual drug approval. FDA is “protecting us.” They want to be as certain as possible that adverse events (side effects) are minimal and not disqualifying, and that the drug actually works, with regulatory efficacy. The previous Phase 1/Phase 2 study is inadequate for all of this — a matter I do not contest in any way.
My point is this. The existing murine and P1/P2 data, coupled with an understanding of how Anavex 2-73 restores normalized neuron function (its hard cellular biochemistry) all predict a very successful Phase 3 trial. The chances that the drug will prove non-effective in stabilizing or reducing Alzheimer’s symptoms, and/or prove to have disqualifying adverse events are, to me, infinitesimally tiny. Hence, I’m confident in the appreciating value of my early equity position in AVXL. Wish I could buy more shares.
You mentioned the heretofore unconsidered factors of insomnia relief and quality of life outcomes for both patients and care givers. I would add the many additional conditions Anavex pipeline drugs will treat; from cancers, psychiatric conditions, heart disease, to epilepsy, and a growing number of others. All of that will play out so favorably in coming years, for both patients and Anavex Life Sciences, I’m certain.
The magnitude of the Anavex medical revolution is unappreciated by most. Few are able to envision it, for several reasons. Commonly, Anavex’s Alzheimer’s approach is erroneously conflated and mixed with the dozens of failed amyloid suppression or removal trials of other drug companies. They all fail; therefore, Anavex 2-73 is likewise destined for expensive clinical failures, too.
Many others fail to understand Anavex 2-73's unique biochemistry and its ability to restore normal cell function. Too good to be true. Appears to be a mystical nostrum. Can’t be true, as future clinical trials will prove (so they think).
Then, Anavex Life Sciences is a pharmaceutical start-up, with no proven revenues, without even an FDA-approved product. The record for such companies mandates a very harsh assessment regarding any retail equity position. Therefore, it’s regarded as a long and potentially bad gamble by so many “experts,” both financial and scientific.
You mentioned the assessment of a placebo effect as a potential cause of clinical efficacy. Not a factor. Not a consideration. No one, ever, has been able to suppress or reverse the multitude of Alzheimer’s symptoms by willful or hopeful thinking.
Anavex Life Sciences and Anavex 2-73 are the real things.
Murine neuron mitochondria and endoplasmic reticula are identical to humans.
Those who wish to await Phase 3 efficacy trials of Anavex 2-73 are certainly welcome to do so.
Presuming that the well-characterized restorative function of Anavex 2-73 as a sigma-1 ligand in murine (rats and mice) neurons is sufficiently different so as to obviate homeostatic restoration in human neurons is founded upon no science whatsoever. Pure conjecture.
The science is very contrary to that notion.