But, for Anavex, when will it change?

Sure it is --- but ever so slowly and reluctantly. Took over half a century for the germ theory to be accepted and applied. Today, eliminating beta-amyloids and tau clusters have been the "rapidly advancing" putative mechanisms for Alzheimer's treatments now for how many years? How many billions of dollars in how many clinical trials of new, advanced therapeutic agents have repeatedly failed? Has Aduhelm validated this "constant change?"

Of course, beta-amyloids and tau clusters have been the accepted, understood causes of Alzheimer's for several decades. All of this was taught in med-school pathology classes; it's therefore an unbending truth.

If medicine is in "constant change," please tell, then, why Anavex science has taken so long to gain any acceptance in the medical community. Is it because it's flawed, really can't or won't work? Or, on the basis of "standard practice" has medicine simply rejected Anavex because it's new, theoretically implausible, and the described new mechanisms of actions of the Anavex molecules can't, in fact, operate?

If Anavex science is authentic, and medicine is in constant (progressing) change, just when will Anavex gain acceptance? For a number of years, on the basis of positive clinical outcomes, I've projected 2023 to be the "Anavex Year."

Because Medicine Rejects Change

Sure.

Anavex is dealing with utterly new understandings of cell biology, stuff that no one learned of in undergraduate cellular physiology classes or later in any med school courses. Can’t be real. Merely hopeful conjectures. The “sigma-1 receptor protein” isn’t in any med school textbook yet; appears only in some recent medical journal papers.

Then, to claim that Anavex’s proprietary, patented molecules could, somehow, safely effectively treat otherwise recalcitrant central nervous system diseases such as Parkinson’s disease and Alzheimer’s disease is phony, on the face of the claim. All the smart people know that Parkinson’s is caused by the loss of nerve cells in the substantia nigra that produce dopamine. Dopamine deficiency causes Parkinson’s symptoms. As we all know (ha), Alzheimer’s is caused by beta amyloid plaques and tau protein clusters. Smart medical people (anyone who even applied for med-school admission) know with certainty that this obscure sigma-1 receptor protein can’t possibly be involved in either the etiology or symptomatology of either of those diseases. Phony on the face of it.

When modern Western medicine began, in the 15th and 16th centuries, its foundation was the ancient writings of the medical greats of antiquity, Hippocrates, Galen, and Celsus. Medical science progressed very slowly. Case in point; the germ theory. It took many long periods (many decades) before medicine would believe that tiny, invisible “germs” could be the cause of diseases. Louis Pasteur originated the idea, but it was rejected for lengthy periods. Diseases were known to be caused by re-breathed bad air, not “germs” in drinking water.

Check to learn how Ignaz Semmelweis was regarded by his fellow physicians, when he showed that their attendance at births, with unwashed (germ-laden) hands caused the deaths of mothers by childbed fever. Semmelweis was like today’s Anavex. His story couldn’t possibly be true. The medical experts knew better.
https://en.wikipedia.org/wiki/Ignaz_Semmelweis

There is only one new medical advancement that was endorsed and applied with little haste: antibiotics in the last century. Everything else has taken time, often with a new generation of med school professors and students. Anavex biology goes against everything medical people know about CNS diseases. Therefore, it has and will take many years (and the conclusion of the big Parkinson’s and Alzheimer’s clinical trials) before Anavex science is taught at med schools. In medicine, new things with new understandings happen very slowly (if at all).

Glaucoma Will Be Just One of Many

Of course, this was a serious technical paper in a peer-reviewed medical journal. It showed that when sigma-1 receptor functions are compromised or disturbed, in this case by glaucoma, brain cell functions are pathologically impaired. No mention of blarcamesine as a therapy, but pathological involvement by compromised sigma-1 receptors was clearly shown.

Clearly very important for cases of glaucoma. Very good chance that blarcamesine could obviate the brain cell dysfunctions caused by glaucoma.

But this is just another new finding about the sigma-1 receptor protein, when it functions properly; something that blarcamesine facilitates. The involvement of the sigma-1 receptor protein continues to be discovered in ever greater numbers of diverse pathologies. Because of proper activation of the protein by blarcamesine, any number of additional, unexpected pathologies may favorably yield to blarcamesine therapies.

Five or six years ago there were daily postings on this message board claiming that blarcamesine’s (Anavex 2-73's) “activation” of the then little-known sigma-1 receptor protein was highly questionable. The molecule apparently did bind to the sigma-1 receptor protein, but so what? Sigma-1 receptor biology was poorly and incompletely known. How this protein might be able to modulate or facilitate a diverse number of otherwise unrelated cell processes was unknown; therefore it was disregarded. Impossible, it was contended.

Notice that such naysaying postings haven’t recently appeared. Sigma-1 receptor biology is becoming known and understood. Do a PubMed search on “sigma-1 receptor protein” and see what comes up. A multitude of new papers in the last several years. It’s newly-discovered cellular biology, with profound applications. This new paper on sigma-1 and glaucoma is an example of the many others that will be published soon enough. The evidence continues to accumulate: compromised function of the sigma-1 receptor protein causes an ever-widening spectrum of diverse pathologies. Eventually, it will be discovered that restoration (or maintenance) of sigma-1 receptor functions by blarcamesine will yield profound health benefits, for a diversity of seemingly unrelated diseases. In the twentieth century it was antibiotics that yielded the greatest therapeutic results and changed medical practice. In this century it will be blarcamesine.

First Wins?

Yea, that's the presumption of some.

If so, Anavex can just now fold and go home. Biogen's Aduhelm was first to market with a "real" (ha) Alzheimer's therapy. In one or two years, when blarcamesine is finally approved for the disease, no one will want it. "Blarcamesine? No, I want grandma on Aduhelm. They were first in the game. Biogen wins."

Sure.

Mothers will move their daughters to blarcamesine.

But the “moving” side effects of the drug will prompt mothers of Rett syndrome girls to request prescriptions for blarcamesine, once it’s available. A moving side effect of Trofinetide is diarrhea. Blarcamesine does not induce intestinal mobility or activity.

Will Happen...

...All of which evaporate when positive clinical outcomes prompt the submission of a New Drug Application (NDA) to the FDA. All of that will happen.

UK Right and Left

Let me help them.

"Tories," the Conservative Party, are on the right. "Labour," the Labour Party, are on the left.

Three-letter word change.

Most likely, just added "not."

Gotta learn from the real experts....

A wise gesture. The managers of the big mutual funds who bought millions of Anavex shares must have the same ignores when they so infrequently consult this message board. When Anavex goes bust, they will have a lot to answer for.

Myself, I’ve got time to kill, so I have no ignores; read every post each day. I’m very egalitarian, ‘woke,’ even, when attempting to consider everything I can about my precarious AVXL position. I wilfully persist in the delusion that Anavex Life Sciences Corp will be a pharmaceutical success. To attain some state of putative Anavex sanity I scrutinize the postings of the helpful Anavex naysayers — but to no avail.

But all of us, Anavex pumpers or naysayers, can rest assured that sooner or later the FDA will decide the matter. The naysayers are certain that FDA officials possess the expertise expressed in their postings here. Therefore, Anavex Life Sciences Corp is doomed. All of us must merely await the Rett rejection.

Another matter comes to mind. Everyone needs to search for the number of Anavex shares corporate insiders have sold off, taking quick profits before the FDA closes the Anavex barn door. Haven’t seen any of it. But if or when it occurs, I’ll learn about it right here. It’ll get posted as soon as discovered. Some, who use the ignore function, will lose out. I’ll spot the news of insider selling the day it occurs. Thanks, people. So helpful.

Message board experts, or stock fund managers?

But who should know...about the validity of the Rett results?

The really smart people, on this investors’ message board, who know the precise ins and outs of CNS disease clinical trial endpoints, have made it very clear. Anavex screwed up with their Rett trial, and that means blarcamesine won’t be approved for Rett. The company therefore will have no revenues. No one should park any dollars in some AVXLs. To do so is ‘nonsense.’

But, wait. Just what could the managers of those investment funds be thinking? Millions, not thousands of shares of AVXL bought so thoughtlessly. You’d think they’d be checking the many daily postings here, telling the real story of Anavex. Have those guys done any DD, "due diligence" (better, "determining diligence")?

On out, I’ll be sure not to buy any shares of any of those funds. All on my don’t-consider list. When I get a few more dollars, I’ll buy some more AVXLs straight, nonsensical fool that I am. Who should I follow or emulate? The guys running the mutual funds, with their hundreds of millions at stake, or the experts here, who have nothing at stake?

Just being conservative.

Yes, 2023 has always been the target year from my personal assessment of the value of my AVXL investment. By the end of 2023 blarcamesine will have attained regulatory approval, either in Australia, or the US. By Dec 31, 2023, the AVXL share price will have "taken off; probably requiring three digits; >$100.

But, as so prominently and profligately advised by the naysaying posts, I'm being conservative in moving the evaluation out to 2024. Playing everything safely. In 2024, the AVXL share price will have risen for everyone's position. The only real question then will be, how many AVXLs were accumulated, at what price. If anyone would like, I'll make the comparison in either 2023 or 2024.

But I'm really looking out five or more years, when Anavex Life Sciences Corp is a major pharmaceutical, after transforming and revolutionizing the treatments and preventions for a diversity of diseases and conditions. To lay out what I see over that near horizon, and to give sound reasons why I expect that play-out (the science) to occur would only prompt another round of "nonsense" postings. For now, I'll keep such nonsense to myself. In time, it will produce many-cents (well, dollars). (What was that anticipated share price? $1249? In 2023 or 2024?)

No—a different investment perspective. Compare in 2024.

Nonsense? Really?

What’s the average cost basis, then, of your AVXL holding? Do you even have one? Probably not; you will follow your own advice and “watch for trial results” before taking a position. For you, avoiding such ‘nonsense’ is appropriate. Understood.

OK, then, in 2024, let’s compare the average cost basis for our respective AVXL positions. Let’s compare, also, the per-share value gain over the periods each of us have held our Anavex equity positions. I just checked my current average cost basis for my several thousand shares; it’s presently $2.91. With the quoted share price at this moment at $11.87 I have a very nice value gain. What’s yours?

And, I very much have treated “this like an investment.” Pretty handsome for the five or six years I’ve been invested in Anavex Life Sciences Corp. The value of my holding at this moment is 3.8 times greater than my total purchase costs.

All of this, over these many years, has occurred with small purchases; with only the discretionary dollars left in my family budget after all obligations and other financial obligations have been covered. If all of the blarcamesine clinical trials fail (won’t happen) and Anavex Life Sciences Corp goes bust, my financial status is unchanged in any way. I have a very well-managed teachers retirement system annuity. My moderate investment in Anavex has not touched or jeopardized my retirement annuity in any way.

Again, let’s check back in 2024 and see how all of this has played out for each of us.

Merely a Matter of TIme

Quite so.

Who would fork out investment dollars for shares of a new, start-up drug company that says it’s going to fix (treat and/or prevent) recalcitrant central nervous system (CNS) diseases such as Parkinson’s and Alzheimer’s? Only one group; people who have closely studied and understood the now wide body of evidence showing that the unique, novel mechanism of action (MOA) of the company’s proprietary molecules will actually be successful for the targeted diseases.

That’s what we AVXL longs have done, propitiously. We’ve taken AVXL positions long (years) before the company has completed the required Phase 3 clinical trials; the ones that will allow regulatory approval for sales and therapeutic use. Big revenue streams will follow shortly thereafter. Then, “Wall Street” (actually, equity investors across the entire globe, not just some guys next to a building in lower Manhattan) will recognize the “proper valuation” of a share of AVXL.

We longs got ours for under two bucks. Next year, the AVXL share price will require three digits. Varying investment strategies. By 2024 all will be welcome and successful. Merely a matter of time.

Blarcamesine Beats Trofinetide, Regardless

Well, if I had a daughter with Rett, and saw those data comparisons between blarcamesine (Anavex 2-73) and trofinetide, do you think I’d go with trofinetide because Anavex made some adjustments in what they were measuring during the clinical trial, which then showed these favorable outcome metrics for blarcamesine?

— Safety —
Blarcamesine: Diarrhea – 0.0% Vomiting – 0.0% Fever (Pyrexia) – 0.0%
Trofinetide: Diarrhea – 56% Vomiting – 22% Fever (Pyrexia) – 11%

— Efficacy —
RSBQ:
Blarcamesine: -14.5
Trofinetide: -4.4

How dumb does anyone think mothers of Rett girls might be? Only two things really count: safety and efficacy. Blarcamesine wins, big, for both.

A Big Alzheimer’s Trial is Ongoing

Are you suggesting, then, that the ongoing big double-blind Alzheimer’s clinical trial with blarcamesine is too “tiny” to validate the drug’s safety and efficacy?

After the unique MOA (mechanism of action) of the drug is proven in both pediatric and non-pediatric Rett patients, in the two Rett clinical trials, followed by similar positive results in the Alzheimer’s trial, what will then prevent regulatory approval (by the FDA or other)?

Things couldn’t be more favorably aligned. Each trial yields positive outcomes, mutually supporting the findings of previous trials. When the Alzheimer’s trial concludes, there will be no data upon which to deny blarcamesine’s approval. That should be some time in 2023. Given the eventual benefits to CNS patients and AVXL equity investors (not traders), we long-term holders of AVXL positions can patiently wait; with patience, for patients.

Blarcamesine for Rett can be all in-house.

Actually, there is no reason whatsoever that the Rett market can’t be serviced entirely in-house, by Anavex alone. No need for an expensive mass of field reps making appointments with physicians, trying to get them to prescribe the drug. All of the required info will be on the drug info sheet and on professional Rett treatment websites. Once approved, every mother with a Rett daughter, and every Rett-attending physician will learn of drug. Blarcamesine will be the SOC (standard of care) drug. Merely a matter of the writing of a prescription. That prescription at any drug store will allow the pharmacy to contact its supply service for delivery. In a day or two it can be picked up and administered to the Rett patient. Nothing complicated about any of this at all. Again, no need for a mass of expensive field reps (drug sales people) to get physicians to prescribe, or patients to take the drug.

Who gets the first SIGMAR1 Award?

Which country, or drug approval agency will get the new, first SIGMAR1 Award.

For physics there is the Nobel Prize for Physics, recognizing new and important findings in the science of physics. For CNS and related disease drug approvals there now needs to be the SIGMAR1 Award. The collective body of expertise on this message board can assemble ourselves, deliberate for a time, and then make that award.

Of course, the 1st SIGMAR1 Award will be conveyed when blarcamesine gains regulatory approval. Given the results of the recent Rett study, it’s only a matter of which country moves first on the matter.

But more than the science.

Yes, it is the unique science of the Anavex molecules in cells and organs that will drive the company to status as a Major Pharmaceutical in a few years.

But the science, alone, is insufficient. The science is merely an academic understanding of how the molecules promote favorable cell processes. That’s merely detailed text in a paper; concept, not reality. Reality is when the drugs can be used therapeutically. That requires regulatory approval, which pre-requires detailed and proper clinical trials. That’s where Missling and Anavex excel; being able to think and operate outside of the confining boxes of legacy medical convention, seeing and bringing to operation things no one else thinks possible. Once again, the genius of American invention.

Mothers of Rett daughters will speak.

Thanks, me too.

But my enthusiasm, even if expressed cogently, won't count. As noted, the only thing that counts is what actually happened to the women with Rett taking blarcamesine. At the end of the trial, were there severe adverse events (side effects) that would preclude clinical use of the drug? And, were there statistically significant (not merely by chance) reductions in the disease's symptoms?

Positive on both accounts. In every clinical study, in either murines (lab test rodents) or in real humans, unlike most other nerve-acting drugs, there have been no disqualifying or severe side effects. Once again, blarcamesine has proven itself to be safe.

But much better was the very favorable suppression of the difficult symptoms of Rett syndrome. After learning of those there's not a single mother of any Rett patient who wouldn't petition her daughter's physician to get her on blarcamesine right off.

As noted before, for non-pediatric Rett syndrome, blarcamesine WORKS; safely. The mom's will speak much louder than me.

The only things that count....

Yes, this is what actually happened in the non-pediatric Rett clinical trial, for which the results were recently revealed.

All were statistically significant, and targeted endpoints were reached. Everything else is murky message board chatter, none of which will or need be considered by the FDA when they make their blarcamesine approval decision.

Not dots; only double-blind clinical trials.

Won’t be either.

In modern 21st century medicine connected dots are never the basis for new therapeutic approaches. They merely ‘suggest’ that some big, double-blind clinical trials should be conducted, primarily to “prove” that the connections are false, do not, in fact, support or allow the new therapies.

Connected dots do not constitute modern “evidence-based” medicine. The only evidence that can be accepted is the statistically-significant evidence produced in a large Phase 3 clinical trial. Often, that isn’t enough. The clinical trial must be replicated “to be sure.”

All of this is even more difficult when the connected dots create a graphic figure that doesn’t appear in any med-school textbook; when the involved modalities conflict with “what is known.” Such is the great problem with blarcamesine and the other Anavex sigma-1 receptor activators. They go against everything known about the CNS diseases they target. The notion (a big smeared dot) that some extraneous molecule can bind to the sigma-1 receptor protein and thereby facilitate or modulate a diversity of favorable cellular processes has no description in any med-school textbook. Too good to be true; therefore must be a falsehood.

Even with positive clinical outcomes, as presently the case with blarcamesine against non-pediatric Rett syndrome, there will be no quick white coat boarding of the Anavex train. The medical powers that be see that train stuck on a sidetrack somewhere, absent any truly substantiating clinical results.

I’ve posted on this before. In all the world, there are two professions that over the centuries have resisted new knowledge, understandings, and practices: medicine and agriculture. For medicine, the thalidomide disaster will never be repeated. Every drug will require proper clinical trial results; not merely some cerebral connecting of extraneous dots; no matter how big, hopeful, or precise those might be.

But then for other conditions?

That's very likely. Hope it works out that way.

But, if it does, could a physician then prescribe blarcamesine, off label, to obviate seizures in patients without Rett or Fragile X syndromes? That's the question with the wider implications for blarcamesine sales by Anavex.

Testing for seizure prophylaxis.

Those with detailed experience and knowledge of drug-approval clinical trials are invited to render their perspectives on this, but it seems that conducting a clinical trial with blarcamesine as an anti-epileptic therapy could be problematic.

An epileptic seizure, I’m sure, could be precisely diagnosed and validated as such. There must be characteristic brain-wave dynamics that could be assessed. But there are a diverse number of epilepsy etiologies, exact causes. Some are caused by traumas (physical injuries), some by tumors, others by ischemias (brain blood clots or hemorrhages). There are other etiologies.

So, how does a Contract Research Organization (CRO) conducting a clinical trial select trial participants for a test of blarcamesine as an epilepsy therapy? Seems that Anavex would have to first target some particular pathology for which epileptic events are common.

In fact, blarcamesine’s ability to suppress, weaken, or prevent episodes of epilepsy may be discovered incidentally; as in the case with Rett syndrome. Rett syndrome girls or women taking blarcamesine are very likely to have significantly fewer or weaker episodes of epilepsy. The drug will prove efficacious for that debility. But getting approval to use it for other causes of epilepsy may take some time.

Blarcamesine and The SOC.

Same thing with me. My father, with diagnosed Alzheimer’s was in the donepezil clinical trial. For a while, for some number of months, the drug seemed to slow the progression of symptoms. Then, an even stronger resumption of symptomatic progress, to death. My mother, an accomplished geriatrics nurse with much professional experience with Alzheimer’s said that had she had to pay for donepezil she would have not allowed it for my dad. The expense not worth the meager treatment benefits. He got the drug only because he was in the clinical trial.

Of course, presently, donepezil (trade name Aricept) is the SOC (standard of care) Alzheimer’s drug. It doesn’t work very well, or very long; but it’s all that’s available. In its big Alzheimer’s trial blarcamesine will have to demonstrate equal or greater treatment efficacies to get FDA approval. That won’t be hard. Aricept is a low hurdle to leap; easy to do for blarcamesine. No leap, just a small step is required. Blarcamesine Alzheimer’s results will be safe pole vaults over Aricept.

Blarcamesine first in the UK? Or, Down Under?

Two things to consider. First, the real possibility that the UK steps right out and approves blarcamesine for Rett; as a demonstrated measure affirming Brexit (British exit from the European Union and its pan-European rules). The first approval for sales and therapeutic use of blarcamesine could occur in the UK.

Or, the Australian Therapeutic Goods Administration (TGA) could make a similar ruling. The clinical trial of blarcamesine against non-pediatric Rett syndrome patients was centered in Australia, was it not? It has been posted that the US Food and Drug Administration (FDA) actually was not the controlling, registration, or moderating agency for the study; it was the TGA. If so, blarcamesine may first get approved Down Under.

Are these possibilities, too, for either the Parkinson’s disease dementia (PDD) clinical study, or the big Alzheimer’s clinical trial?

The FDA is not the only drug approval agency in the world. A lot of blarcamesine clinical work has been done in Australia, under the TGA. Anavex’s targeted CNS diseases do not respect national borders; are extremely costly for health care systems globally. Why is the focal concern only with the FDA? Please explain.

Do a web search “sleep deprivation costs, frequencies.”

Gigantic medical problem, pretty much unsolved. The prescription soporific drugs are marginally effective; have severe side effects. They don’t much solve the sleep problems that millions have. There is a giant market for a pharmaceutic solution.

From all of the data from blarcamesine in humans, in early-stage and preclinical trials, the drug induces sound, healthful sleep. The early blarcamesine trials show that the drug as a safe, useful soporific, but this has not been mentioned here for some time. Understood.

Seems that Anavex hasn’t wanted to pursue the sleep induction market. The CNS diseases market is far bigger as a first target. The insomnia market can come later, after blarcamesine is treating CNS diseases.

Anavex fixing sleep problems will be a chapter much later in the book, straddled by the prophylaxis chapter and other new applications at the bottom of the pipeline list.

Negating details not presented.

This is the question that I want answered, with specific notation and reference to verbiage in the released trial results.

Tell us, please; what's in there that makes blarcamesine a failure against Rett syndrome in non-pediatric patients? Be SPECIFIC, please. Tell us exactly why blarcamesine cannot be approved by the FDA to treat non-pediatric Rett syndrome? Inquiring minds want to know --- the details.

Numbers now, or in years out?

Those 4-digit AVXL share-price projections, several years out, match the ones my spreadsheet calculations present. I make the same presumptions; that blarcamesine will be approved as an Alzheimer’s therapy, and that several million will then take the drug, at the projected $10/day expense.

Of course, the numbers may be off by 50% or more. Alzheimer’s is an un-treatable malady in the rest of the Western world. The European market should match the American. The numbers very reasonably could then be doubled.

But that will be only the Alzheimer’s chapter in the Anavex story. Once hundreds of thousands are taking blarcamesine it will be incidentally discovered that not only are their targeted pathologies being resolved by the drug, but they incidentally are far less subject to other diseases (such as viral infections such a COVID, colds, flues, etc.).

After a few years (Should be but a few months, but the FDA is, to use an inept phrase, is “always cautious.” Never again any thalidomides.) very high chance blarcamesine is allowed to be used as a generalized geriatric prophylactic. Take the stuff to prevent or delay the onset of a host of geriatric diseases and conditions.

At $10 a day, that’s an annual drug cost of $3650. If blarcamesine works as a late-adult generalized disease prophylactic, would that annual cost offset the eventual healthcare costs of the prevented diseases in old people? Almost surely.

Not included in any of these projections are the yet-to-be-confirmed efficacies of Anavex 3-71. Every bit of evidence shows that it is likely to eclipse blarcamesine in every regard, yielding even better and more diverse disease preventing and treatment outcomes. In the end (five years from now) Anavex 3-71 will likely supplant blarcamesine, yielding both greater treatment outcomes and revenue streams.

In over a half-decade I’ve accumulated my modest AVXL holding as a long-term investment, not a trading vehicle. Most likely I’ll never sell a share. The holding will remain in my estate, to the benefit of my family, church, and community benefactors. My wife and I, in our remaining years (free of geriatric dementias of any sort) will live very comfortably on Anavex dividends. I’m a biologist, can comprehend the unique cellular biochemistry of the Anavex molecules, and note cogently that they are both safe and efficacious. Not a shred of evidence in either murines (lab test rodents) or in any humans in any of the several trials that blarcamesine or Anavex 3-71 produce any clinical data indicating that they can’t or won’t be approved. I won’t go into them here, but I’ve previously laid out many of the potential problems with neuroactive drugs. The Anavex molecules have none of them.

I sleep well knowing that I must wait until the Parkinson’s disease dementia and Alzheimer’s trial results appear. The Anavex naysayers will strive to tell why, once again CEO Missling and the company’s drug have failed and it will not be approved. Same quibbling, whining chatter as now. But to no avail. I can wait until 2023 or 2024. Missling, blarcamesine, and Anavex will then be vindicated. All will be well; especially for the millions benefitting from blarcamesine treatments.

Any reasonable shareprice conjectures?

ALPPine share prices presently continue to slide sideways. I’m trying to estimate the potential value of my ALPP holding at the end of 2022. Any reasonable, conjectured share price ranges in a year? I bought a bunch just before the NASDAQ uplisting, anticipating the envisioned share price rise. Hasn’t yet happened. Thoughts? (Not going to sell my holding; will wait no matter what happens.)

What will parents and caregivers decide?

Well, I’m certain that parents and caregivers of women with Rett syndrome will see right through all of the positive things disclosed in the trial results. Instead of focusing on how blarcamesine has been clinically shown to significantly treat and relieve the symptoms of Rett syndrome in older, post-pediatric subjects, they’ve read the so important info here, showing that Anavex "adjusted things” during the trial, so their people with Rett shouldn’t take blarcamesine. The clinical results were really good. On the basis of just those life would be so much better for the women with Rett.

But, nope. Can’t or won’t be. Certain alleged “adjustments” during the clinical trial entirely negate, disqualify both the positive safety and efficacy outcomes. More than we incidental AVXL shareholders the parents of women with Rett know what their girls should be taking. They aren’t going to stand for any effective, safe drug that had some sorts of “adjustments” happen during the clinical trial. Not gonna have any of that, for sure.

Or....

Another Blarcamesine Success, in Humans

Anavex/blarcamesine naysayers really have to stretch to find facts that show that the drug is either unsafe or ineffective. Have we seen any of those failures laid out today? The clinical outcomes from the completed clinical trial in humans, with advanced cases of Rett syndrome, are all positive. Not a single datum (compared to placebo) was negative. All clinical outcomes are statistically significant.

https://www.anavex.com/_files/ugd/79bcf7_ca78f07355544ad794235b95a121f8d0.pdf

This continues the universally positive findings in every clinical study of blarcamesine; first in trans-genic (human-diseased) murines (lab rodents), now in a placebo-controlled Phase 3 clinical study in diseased humans. This will continue with the Parkinson's disease dementia and Alzheimer's trials. For blarcamesine, the FDA will have it.

Facts and experts of no consideration.

No, any of that would be “news,” only. Until a company has revenues, against which a share price can be compared, as presently the case, the share price will swing wildly, mostly downward. Doesn’t make sense, but it’s what happens. Has happened virtually every time “real news” comes out about Anavex.

Look at the factual postings today. Several renowned medical experts, MDs and PhDs working in CNS diseases, have plainly stated that blarcamesine is now a therapeutic success against Rett syndrome. But at this early drug development stage, people working AVXL share prices pay no attention to “experts” or “scholarly papers.”

Watch. When the Rett support organization comes out with a positive statement there will be immediate (pre-written) postings about how results actually were weak, cherry-picked, and insufficient for FDA approval.

The people who know have already taken and continue to hold their AVXL positions; many of us “perma-bulls” here, along with an increasing number of institutional buyers. For us, collectively and affirmatively, we see over the cluttered day-trading horizon to a fantastic Anavex future. Years out, not days, weeks, or months. A matter of time perspective.

Blind? Nope. We see beyond the horizon.

Well, by all accounts I’m an Anavex “perma bull.” I’ve been accumulating AVXLs for over five years; have been posting explanations of the successes and modalities Anavex science for that entire period. Virtually everything I’ve described or predicted about Anavex science has been demonstrated to be so; today it’s blarcamesine’s unique MOA (mechanism of action) on the sigma-1 receptor protein propelling propitious therapeutic outcomes in real humans.

The wild AVXL price swings certainly are interesting. They fit perfectly with the visions and understandings of the Anavex perma bears. Wonderful stuff — for day traders. Congratulations. We marvel.

But we longs don’t trade. We buy, then hold. Personally, I don’t care a wit about the day to day AVXL share price. I will wait and consider it in late 2023 or sometime in 2024; when blarcamesine is approved to treat Rett syndrome, Parkinson’s disease dementia, and finally, Alzheimer’s.

Day-trading bears can work the varying AVXL share price simply because Anavex Life Sciences Corp has no revenue streams. Presently, the company is a biotech or pharma start-up. Until there’s a revenue stream, everything related to the daily share price is speculation; most of it negative; as demonstrated by the AVXL share price just this minute.

Tonight, like most of my perma bull compatriots, I’ll sleep even a bit better. Sometime today, for fun, I’ll start punching in new anticipated Anavex revenue streams in 2024 and the years on out. Soon enough (for us longs), the AVXL share price will be stated in four digits before decimal point.

Anavex MOA WORKS. PDD and Alzheimer's Next!

The results announced today are really fine for girls suffering from Rett syndrome. Now, they have some hope for a more normalized life.

But there's a much bigger factor, for the millions suffering from Parkinson's disease and Alzheimer's disease. For both of those recalcitrant central nervous system (CNS) diseases the unique, particular mechanism of action (MOA) of blarcamesine, binding to and propitiously activating the sigma-1 receptor protein, was still in question. Sure, pre-clinical studies in diseased murines (lab rodents), along with some early safety and tolerability (Phase 1) studies in humans strongly indicated that blarcamesine would be both safe and therapeutic, but both the MOA and the therapeutic results were still in question in humans.

Understandably. All of the murine results from blarcamesine were "too good to be true." No obviating side effects --- extremely uncommon in neuroactive drugs. Then, results too good to be true. Transgenic rats with severe, fully-developed human-genetic Alzheimer's get their cognition rather fully restored. Of course, that was by a similar Anavex drug, Anavex 3-71. But it's MOA is identical to blarcamesine's; acting on the sigma-1 receptor protein.

It is now fully established that in humans the blarcamesine MOA is therapeutically functional. It WORKS. Because of that, the results in the on-going Phase 3 Parkinson's disease dementia and Alzheimer's disease trials will be positive. Medical science will be changed going forward. Sigma-1 receptor protein activation will be quickly entered in the med-school textbooks. In the 1940s it was penicillin and antibiotics. In the 2020s it will be the Anavex drugs and their CNS therapeutics.

Murine Data Confirmed in Humans

Whadya know? The murine trials of blarcamesine successes against Rett were entirely predictive of the drug in humans with the disease.

Wanta now contend that this won't be the case in both Parkinson's disease dementia and Alzheimer's? Ha.

When I get a few more discretionary dollars, I'll be expanding my AVXL holding.

Not A "Purchase? How So?

Not a purchase? Please, then, tell us how we, too, can acquire AVXL shares without purchasing them.

If it wasn't a "purchase," there wasn't a seller (former owner of the shares, who agreed to sell them), and there could have been no purchaser, either.

Right now, Barchart shows that a big trade was made at 16:40 ET, at a trade price of $13.20.

This "no purchase" proclamation fits in no way with common sense or posted trading events.

So, tell us how you are certain the trade wasn't executed by or for "one person." Do you have inside info on some hedge fund, perhaps? If so, do they, too, make big new equity buys on a whim or lark? Tell us, why do you think "they" made this trade? Inquiring minds (who are otherwise careful and diligent in their own trades) would like to know. Help us out, please.

Wasn’t A Whim Purchase

Well, if I had millions of spare dollars to invest, knowing what I know about Anavex Life Sciences Corp and their molecules, l’d make such an acquisition.

But I’m just a small-time retail equity investor, having acquired over many years an AVXL position of a few thousand shares. No comparison to the party that made this end-of-day acquisition; except that....

Except that no one forks over that amount of money on merely a hopeful whim. The party that made this trade, as have I, has done his determining diligence. The extant information on blarcamesine has been scrutinized and applied.

Perhaps someone with means read and comprehended Mayo’s new website.

Or, some inside information has escaped and was acted upon.

As with everything else Anavex, time will tell.

Eventual Discovery in Humans of Antiviral Efficacy

Ok, very likely the SARS-CoV-2 virus, by natural selection, will devolve to a persisting pathogen, in the manner of colds and flues. No evidence whatsoever that any of the current "vaccines" will be able to extinguish the virus from any human population.

So, in two or three years from now, when blarcamesine is the SOC (standard of care) therapy for at least three morbidities, Rett syndrome, Parkinson's disease dementia, and Alzheimer's, it may be inadvertently discovered that those taking the drug don't suffer from SARS-CoV-2 infections themselves, or even other common viruses such as those of influenza and common colds.

First, is there any chance for this to be the case? Well, if activation by blarcamesine of the sigma-1 receptor protein facilitates (as it does) a diversity of "downstream" cellular maintenance functions, restored, optimized autophagy within cells will facilitate the destruction or expulsion of virions, virus particles. If viruses can't get inside cells, they can't replicate. They are a pathogenic dead end; merely an extraneous packet of non-functioning genetic nucleotides (DNA or RNA).

As Dr. Missling's long-ago statement "like an iceberg" might indicate, when tangentially in reference to the potentials of the Anavex sigma-1 receptor agonists, I'm certain that Anavex insiders know far more about their drugs than they are presently telling. It's not at all expensive or difficult to infect various common lab test animals (murines, rats and mice; Ceanorhabitis elegans, a common lab roundworm used for genetics, aging, and pathogen research) and see how treatments with Anavex molecules affect various microbial infections.

Restoration of optimized cell functions by blarcamesine might well yield profound antimicrobial outcomes. Not just time, but the reduced incidences of viral infections in people taking blarcamesine will tell.

Of course, categorically that fits inside the blarcamesine prophylaxis thesis; that dosing with blarcamesine will prevent the onset of various diseases, such as the targeted CNS diseases, along with the debilities of normal advanced aging.

Right now, we're still in the early chapters of the eventually gigantic Anavex story book. It won't be just Rett syndrome....

Blarcamesine "Now" for Rett

Well, it'll have to be "then," can't be "now."

As with all matters Anavex, patience is required; especially for patients (and AVXL shareholders).

Rett, only?

Why just Rett "now?" The number of girls with Rett is a fraction (tiny) of people with Parkinson's and Alzheimer's diseases.

Or, are you presuming blarcamesine (Anavex 3-73) must first "prove" itself on some lesser central nervous system disease before it can even be considered for the two biggies, Parkinson's and Alzheimer's?

Were they to know the evidence for blarcamesine efficacy and safety against Parkinson's and Alzheimer's, people (and caregivers) with those diseases would inveigh a similar "now" immediacy for blarcamesine.