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Another Big Finding: No Therapeutic Falloff
Slide 29
Patient Cohort with Cognitive and Functional Improvements at 57 Weeks:
Retained Response at 109 Weeks
Here's the Big Finding (As I Expected)
Alzheimer’s patients with milder disease stage (baseline MMSE >20) tended to respond better to ANAVEX2-73 than patients with more advanced disease stage (baseline MMSE <20).
Shorts Will Be Just Fine
Shorts are in for a long weekend waiting until Monday to see how bad they are going to get burned.
Dose Concentration Can Affect Response
Is it likely that patients on the lower dosage just need more time to see the results of cellular homeostasis?
Approval Not On Science, Just Results
If 2-73 is proven to reconnect the endoplasmic reticula and the mitochondria and it can be physically seen through imaging technology and we know that the reconnection is vital, couldn’t/ shouldn’t we be approved based on that fact alone?
Science Affirms Anavex Science
Today’s Science, the premier science journal of the American Association for the Advancement of Science, features new research further elucidating the crucial nature of the endoplasmic reticulum-mitochondrial connection, telling that when this is broken, disease ensues:
More importantly, it is known that ER-mitochondrial tethering is disturbed in Alzheimer's disease, Parkinson's disease, and amyotrophic lateral sclerosis with associated frontotemporal dementia.
Sigma-1 Receptor Agonists Vary
It is an error to presume that any and all sigma-1 receptor agonists are virtually identical or equivalent, either as to binding strengths, molecular shape, or most importantly, as to clinical efficacy against central nervous system diseases.
Rather like claiming carbohydrates are all the same, have the same biological effects, etc. Like claiming all sugars are the same as all the starches, etc. All are carbohydrates.
Yes, there is a generalized category of cellular molecules known (now) as sigma-1 receptor agonists. But to presume or imply that Anavex 2-73 can be no different from the few other sigma-1 receptor agonists is an error; as all clinical results indicate, whether in murines or humans.
Criteria for Nobel Prize in Medicine
You need to learn what the Nobel in Medicine is awarded for.
The Nobel Prize in Physiology or Medicine, administered by the Nobel Foundation, is awarded once a year for outstanding discoveries in the fields of life sciences and medicine.
Anavex 2-73 and Prodromal Alzheimer’s
The upcoming Phase 3 clinical trial of Anavex 2-73 is targeted, conventionally, at mid- to mild-case Alzheimer’s patients. These people are in decline, have Alzheimer’s symptoms that preclude normal living patterns and functions: cognitive deficiencies, etc. There will be no doubt that the drug is being tested on people who actually have the disease. Should (as expected) the drug terminate cognitive decline, holding things at the level at the start of the trial, or even increase cognition abilities, the drug will be approved by the FDA.
The Phase 1 / 2 safety and tolerability study In Australia established a very favorable safety profile, with all of the adverse events (few) at only Levels 1 and 2.
If the new, much bigger study replicates the outcomes of the Australian study, FDA approval shall occur, inasmuch as the existing Standards of Care, the four drugs presently approved for Alzheimer’s, have never approached the favorable therapeutics of Anavex 2-73. None of them stabilize or improve cognition; they merely slow its decline for a short period.
All well and good. Anavex 2-73 is very likely to gain FDA approval. But that’s not the real story. I contend the Big Anavex Story will be with people with prodromal Alzheimer’s, people who have just the first symptoms of the disease, when it first begins.
I’m familiar with this, as my father suffered and died from Alzheimer’s (and was a clinical participant for one of the four Alzheimer’s drugs, during their clinical trials, resulting in its FDA approval). We watched my formerly intelligent father, an accomplished tax accountant, slowly lose his ability to think and recall recent events. My mother was a practicing geriatric nurse, and knew from the start, at the prodromal stage, what was happening and how it would lethally end.
That will be the Big Anavex Story. Once approved, Anavex 2-73 will be prescribed at the very first indications of Alzheimer’s onset, at the “prodromal” stage. With this, the drug is likely to be far more successful in suppressing and/or reversing symptoms than in the Phase 3 clinical trial. Those people will have had the disease with the symptoms well-established and rather severe, when it may be harder to control or reverse.
Let’s imagine that Anavex 2-73 efficacy gets established for only about half of the people in the new Phase 3 study. Inasmuch as no present care motif can achieve that, it will be approved. But in practice, when prescribed for prodromal Alzheimer’s cases, efficacies will almost surely be much greater — 100%?
The medical, social, and financial benefits of Anavex 2-73, against just Alzheimer’s, are yet unrealized, not even fully anticipated.
I’ve not stated this before. Pending the Phase 3 results, Anavex 2-73 may have the potential to elevate appropriate parties into Noble Prize contention. Let’s watch.
[This author advises that his postings should not be used to prompt any AVXL buy or sell decision. Anavex Life Sciences Corp is presently a small, no-revenues, no-product start up pharmaceutical. It may have a great future, as its science is unique and effective. But, of course, never put at risk any non-discretionary funds.]
All Three Will Have to Fail --- Will Wait
Any failure can't come until a trial is run.
Retirement Centers, Perhaps
Nursing homes about to become Active Homes
Every Point Plausible
While what you've described is not a real, constructed "plan," it's a sequence of entirely plausible outcomes. There are good reasons to believe that each of these could emerge.
2018 may be the year that medical science and practice change as they never have, all for the good (except for nursing home operators).
Not Just Central Nervous System Diseases
As noted in the article (seldom discussed or pondered here) is the fact that, “...amyloid-beta is produced in blood platelets, blood vessels and muscles, and its precursor protein is found in several other organs.”
This is significant. Those with only a legacy understanding of beta-amyloid plaques and tau tangles presume them to be a) always pathogenic (disease-causing), and b) sited only in nerves or neurons. That narrow perspective leads down dark, dead-end allies. In fact, both proteins may play necessary and beneficial roles in any number of cellular or systemic processes. Clearly, when they accumulate in nerves and neurons, they are pathogenic, causing the cascade of molecular events that result in the several symptoms of Alzheimer’s. If they could be kept from accumulating (which is one of several outcomes of Anavex 2-73 therapy), normalized nervous system function resumes.
But, what if these two proteins do provide useful, beneficial functions in diverse organs and tissues; that they are pathogenic only in un-cleared concentrations in nerves and neurons? The molecular machinery that modulates their normal and helpful functions would clearly not be restricted only to neurons; they would be in all of the affected cells and organs.
Might, then, Anavex 2-73 be able to favorably modulate the production and function of those two proteins in cells and tissues beyond neurons and nerves?
Clearly, the entirety of therapeutic applications of Anavex 2-73 is not yet fully known. Inasmuch as sigma-1 receptors are in diverse cell types, and they can become dysfunctional, Anavex 2-73 has the potential to restore normalized functions in diverse cells and organ systems.
The Anavex pipeline (http://www.anavex.com/pipeline/) indicates as much. It is claimed Anavex molecules, beyond central nervous system diseases, will be therapeutic for depression, stroke, various pains, and at least one form of cancer (pancreatic). Fixing the pathogenic biochemistries of these will be different from Alzheimer’s. The clearance or prohibition beta-amyloid and tau wastes don’t appear applicable. Other molecular reaction sequences are at play — ones that Anavex Life Sciences has enough data to support the inclusion of in their pipeline drugs.
No existing drugs have shown the results and safety of Anavex 2-73 against Alzheimer’s symptoms. Their molecules are unique. There is good reason to believe continuing research will discover new applications, beyond the CNS diseases presently being targeted.
Well, Sure, A Few. So Far. Future...?
Yeah - these guys never heard of Anavex -
Plain Fact. The “Market” Is Anavex Ignorant, Oblivious
Check the record. It supports the notion that the market, whether retail equity purchasers, or institutions, simply pay no attention to, have no interest in anything related to Anavex Life Sciences Corp. Those of us here who have done extensive diligent examination of the company and its technologies know the real story. There is the highest, almost-certain chance that Anavex 2-73 will gain FDA approval as a commercial drug. We see the science. We see the markets for new drug(s). We can intelligently anticipate eventual Anavex successes.
But, pound a hammer on your noggin. Beat the reality into it. NOBODY (except us) really cares a whit about Anavex. First, the Anavex science is incomprehensible for those lacking some thick education and experience in molecular biology. Even with that, many will question any and all of the Anavex data sets — just not solid enough. Placebo effects, inadequate trial cohorts, etc.
The Street is “smart.” It already knows that billions of dollars have been lost trying to solve the intractable Alzheimer’s problem, and those efforts were directed by top-line medical researchers funded by any number of the world’s best and biggest pharmaceuticals.
Anavex Life Science Corp is a new, very tiny horse in the race. And, it’s chances of making it to the FDA finish line appear minuscule. It’s running the race with a saddle and horse shoes no one can understand. It’s trainer, Missling, is un-assailed, but without a real winning record. Intelligent investors don’t bet big on unproved corporate jockeys.
The Anavex training barn has but a few horsemen tending the corporate flock. The company is not big enough, not experienced enough to run against the big horses and their jockeys.
The record shows no one is going to pay any attention to, or buy any new quantities of AVXLs until the game changes, when Anavex actually crosses the finish line with an FDA approval.
Let’s see if I’m right on this. Let’s see if Anavex puts out really substantiating data at CTAD. If they do, I can’t see that it will make any effect on the share price. The Market doesn’t look for, nor understands, technical data sets. The only real thing that counts is anticipated corporate revenues, and those depend utterly on FDA approval.
And that’s not likely until sometime late in 2018 or 2019. Until then, we are talking (delightfully, but fruitlessly) amongst ourselves.
(Sure hope I’m utterly wrong on all of this. But not making any bets on it.)
Will Replicated Numbers Suffice?
Give me decent next trial that is double blind and patient numbers,
Correct, Is An INT Posting.
I also think this message is neither. " cub" nor "fud". Correct?
The Lost Sleep Factor
Just heard an NPR broadcast interviewing a sleep expert, who said evidence continues to support lack of sleep, inability to sleep well in middle age as a major cause of ensuing Alzheimer’s. Sound sleep induces waste protein (beta-amyloid, et al.) removal from nerves and neurons.
In relation to Anavex 2-73 (which wasn’t mentioned), the drug’s ability to induce strong, healthful sleep, before any Alzheimer’s symptoms begin, may be a major eventual use for the drug. Universal restoration or induction of good sleep in the Australian Alzheimer's patients in the Phase 1/2 study there is significant.
Here’s the scenario (mine). Anavex 2-73 gets approved to treat mid to mild level Alzheimer’s patients, a result of the big Phase 3 study soon to start. Better than anything on the market, it works for most, either stabilizing at-the-start cognition, or actually improves it.
Of course, families then will be bringing to their doctors older, or even middle-aged family members just starting to lose memory. Physicians recognize these behaviors as those seen at the start of Alzheimer’s, and, for the first time, they have a drug they can prescribe. So they start prescribing Anavex 2-73 at the earliest signs of the disease — with high rates of success.
And, with this, they find those people start to sleep well once again. They don't go on to dementia.
The correlation, connection, even cause of Alzheimer’s with early sleep lose or poor quality becomes well known. Finally (perhaps quickly), physicians then start prescribing the drug as a sleep loss prophylactic, knowing that chronic sleep loss or poor quality sleep is a strong predictor or cause of eventual Alzheimer’s. Get to it early, and results are better (perhaps 100%).
Finally, because it has virtually no side effects of concern, Anavex 2-73 becomes a drug prescribed, even mandated for all middle aged people. Health insurance companies quickly recognize that daily consumption of 50mg of Anavex 2-73 reduces the chances of Alzheimer’s by, say, 75%. Everyone in their health insurance plans is required to take the drug, before any symptoms appear.
Consequently, Alzheimer’s and Parkinson’s and Amyotrophic Lateral Sclerosis cases plummet. Health insurance rates are markedly reduced. People lead longer, more productive (health care insurance paying) lives. Medicare costs plummet. Everyone (except nursing homes) benefits.
Think this to be overly optimistic? Do your own look-up of “Alzheimer’s, poor sleep.”
Then, for now, just for fun, figure out a likely range of corporate revenues if every candidate American popped a Anavex 2-73 pill every day. Presently, there are about 40 million age 50 or older. Add in Europeans and others in developed countries around the world, and the number must approach or exceed 100 million. And for the foreseeable future, that number will grow each year.
Anavex 2-73 has the chance to be the best ever, all-win drug.
[This author advises that his postings should not be used to prompt any AVXL buy or sell decision. Anavex Life Sciences Corp is presently a small, no-revenues, no-product start up pharmaceutical. It may have a great future, as its science is unique and effective. But, of course, never put at risk any non-discretionary funds.]
Adenosine, Adenosine Triphosphate Different, Unrelated to Caffeine
Was wondering if caffeine in the morning could affect the energy cycle of the cell by preventing adenosine uptake?
Adenosine itself is a neuromodulator, believed to play a role in promoting sleep and suppressing arousal. Adenosine also plays a role in regulation of blood flow to various organs through vasodilation.
Fear, Uncertainly, and Doubt
Acronyms are frequently used in postings on this message board, perhaps because ever more people communicate digitally with only their thumbs (on their cell phones, etc.). Acronyms save keystrokes for those who use only their thumbs (without a real keyboard with physical keys).
I don’t do social media. I do all of my work on a desktop computer, with a real keyboard in my lap. So I have to look up some of the acronyms that appear here. Whatever might “FUD” mean? On the face of it, I presumed it might be something in the order of Frustration, Unintelligibility, and Dumbness.
Close, it appears. Apparently FUD is understood by the social media people to mean Fear, Uncertainty, and Doubt.
FUD, therefore, can certainly apply to a good number of postings here.
Fear. Fear that the Anavex story, mechanisms of action, clinical results, etc. are weak or fraudulent. Or, that the company has only a minimal chance of ever gaining FDA approval for any of its drugs; that it will never be a going concern. Fear of taking or losing any investment in AVXL shares.
Uncertainty. Uncertain about any of the items lumped above with Fear. Uncertain that Anavex Life Sciences Corp can ever get a drug approved and reap annual revenues.
Doubt. Same as the Fear stuff. Doubt concerning anything positive about Anavex Life Sciences Corp.
I marvel at most of the FUDacious postings; pondering a) why they were posted, and b) what intelligent readers attempting to conduct diligent research on Anavex Life Sciences Corp (AVXL) might surmise from them.
I was going to work out a taxonomy of the various FUD postings on this board, but I’ll just keep all of that in my head. FUD postings here fall into just a few categories. Work out your own categorizations of these.
But what, then, might be the antonym of “FUD?”
Confidence, Undoubtedness, Belief. “CUB.”
Readers familiar with my postings can rather clearly perceive I’m in the CUB camp. I have Confidence that the Anavex science is sold and trustworthy, that it will lead to FDA drug approval and rewarding corporate revenues, in time.
Undoubtedness characterizes my understanding of Anavex drug mechanisms of action, clinical results, etc.
Belief describes my understanding and faith in the company as a whole, and the remarkable accomplishments and capabilities of its principals.
I’ll continue to use all of my fingers — few or no acronyms appear in my postings. I strive to “make myself clear.” I would encourage others to strive for this, too. Use acronyms sparsely.
And don’t be afraid to put your thumb on the Shift key at the end of every two or three sentences. Masses of pure text, with no paragraph spacings or line breaks are really hard to read. Comprehension is not well-conveyed by giant screens of just words. In writing, it’s called the “white space factor.” Successful writers and editors use it extensively. Let’s all strive for clarity.
My best to all.
(A post script. For fun, privately, I'm going to start charting the numbers and ratios of FUD to CUB postings each day on this board. I'll take some private delight in seeing how the frequencies FUD and CUB postings change as Anavex matters continue to develop. A bit of technical analysis (yes, "TA") as it were.)
Tell Us, Who Are These "Experts"
Many real experts express real doubts about the validity of results published so far.
In Vitro, In Vivo
"In vitro" means, literally, "in glass," in a test tube, culture flask, petri dish, etc. Live cells are grown and maintained in specific culture media, solutions that replicate the fluids surrounding the cells in the body.
"In vivo" means, literally, "in life," existing in the organism itself.
The question, of course, is can or do in vitro studies accurately predict or replicate in vivo conditions? If it grows or works in a culture flask or petri dish, will the same outcomes occur in the cells in living organisms, mice or men?
Now this is not some new hit or miss, take a shot and see technology. Biologists have been perfecting in vitro study parameters for many decades. They are usually rather predictive of in vivo results. Not definitive, but very indicative; pending final in vivo studies.
Failure of in vitro studies almost always predicts in vivo failure. In vitro successes, more often than not, predict in vivo successes.
Poster Image Message 126696, Below
The Anavex 2-73 ROS Factor
Good to see the information emerging on Anavex 2-73 and its potential as an effective multiple sclerosis therapy.
I noted in the poster that it protects cellular components from reactive oxygen species (ROS). This is big, inasmuch as oxidation stress is pathologically involved in a multitude of diseases and conditions.
Oxygen, in its many chemical arrangements, simply oxidizes things, “burns” them up, as it were. Cells, then, must have natural antioxidants to keep ROSs from destroying both cellular structures and chemistries. Colored fruits and vegetables provide dietary antioxidants, a strong factor in their health-giving outcomes.
If Anavex 2-73 causes or induces antioxidant processes to any great degree, it will have a multitude of clinical application; mostly likely as a therapeutic adjunct to other, existing therapies.
Anavex 2-73 may prove to markedly enhance the efficacies of any number of other, existing drugs. So far, we’ve been able to skim just the first chapter in the eventual giant volume covering the Anavex Life Sciences Corp story.
More Research Targets Mitochondrial Problems
A team of investigators from McLean Hospital and Harvard Medical School, led by Kai C. Sonntag, MD, PhD, and Bruce M. Cohen, MD, PhD, has found a connection between disrupted energy production and the development of late-onset Alzheimer's disease (LOAD). The findings appear in the current issue of Scientific Reports
Big Numbers. Real? We’ll See.
Once again, as before, I just punched some numbers that might indicate future Anavex revenues and dividends, several years away.
THIS IS NOT INTENDED AS INVESTMENT ADVICE.
Readers, on their own, must do their own analyses of Anavex Life Sciences Corp. Either in conjecture or reality, the numbers may not in any way come out as described here. (Likewise, they may even be bigger.)
First, why do I put up these numbers? It’s because they are the quantities some AVXL shareholders can see as reasonable and likely, should the company gain FDA permission to sell Anavex 2-73 for the treatment of Alzheimer’s disease. If the well-described Anavex science continues and completes the up-coming Phase 3 Alzheimer’s trial, these numbers are well within an investment ballpark. (But, again, don’t go off and buy a bunch of AVXLs without understanding all that yet is required for FDA approval. If anyone wants to take an early, speculative position, use only entirely discretionary funds that won’t change anything if lost.)
Let’s presume that Anavex gets FDA approval to sell Anavex 2-73 for diagnosed Alzheimer’s cases. Presently, about 5 million Americans have or will soon get the disease. I’m then presuming similar numbers for the rest of the developed world (Europe, in particular). I will then presume that Anavex will be selling its new drug to 10 million Alzheimer’s patients.
Next, I’ll assume that treatment will cost in the realm of $3 a day, with a general annual income, then, of $1000 per treated patient.
That yields annual revenues of about $10,000,000,000 — 10 billion dollars.
Next, I’ll presume that outstanding shares will have been increased from the present ~41million to a nice, rounded off 50,000,000.
Next, I’ll presume half of the annual revenues are internally consumed on manufacture, marketing, taxes, salaries, etc. With that, $5 billion dollars would flow down to the dividends line item on the annual financial report.
With $5,000,000,000 going out to 50,000,000 investor-held shares, annual dividends would be in the range of $100.
If we assume a typical P/E ratio of 15:1, each share of AVXL would have a value approaching $1,500.
Now all of this could be wrong on every point. All three of the seminal new clinical trials may go bust. If so, I’ve lost the dollars used to take my small AVXL position.
But even if FDA approval for Anavex 2-73 happens, and 10 million subjects are treated at a general daily cost around three bucks, for any number of unknown or unforeseen reasons, far less than half of the annual revenues may not be distributed as dividends. Perhaps 3/4s of the revs are used for expenses, etc. and dividends are then about $25.
Maybe only 10% of annual revs flow to shareholders. That’s a dividend of $10.
So, at the high end, dividends could be in realm of $100, with a share price hovering in the $1,500 range. At the low end, share prices would be ten bucks, with a share price around $150.
Of course, none of this includes revenues from Parkinson’s (big, but not as massive as Alzheimer’s), Multiple Sclerosis, Rett, or any other disease or condition that may prove amenable to Anavex therapy. These conjectures do not involve any widespread use of the drug for prophylactic, preventative purposes — a market that could be many times larger, for every person in their 30s, 40s, or 50s.
Perhaps. (All of this is perhaps stuff. Don’t do anything stupid.)
If So, Are You Short?
This will be in penny land after CTAD, true valuation for this stock is close to $0.5
One Cause Is Mitochondrion-Endoplasmic Reticulum Disconnection
...the cause is in the ineraction between immune system and neurons.
Why Not Anavex?
1. The company’s claim (by the CEO) that they’ve got enough funds, in house, to conduct the three up-coming clinical trials for Anavex 2-73 just can’t be correct. The company is making all of this up. Smarter people here know and state for sure the trials will cost more than the company has in the bank; so they will have to sell a bunch of new shares, cheap, to finance the trials, and we shareholders will have our positions relatively reduced. Classic dilution, common for young, big-idea, poor-results start-up companies that fail.
2. The presentation of symptomatic data derived from the Australian trial is a) at least murky and hazy, not presenting with clarity essential data parameters, or b) it’s plainly fraudulent, not accurately representing the actual symptomatic responses of the trial’s participants — that weren’t at all as positive as presented. The presented data simply cannot be trusted; they don’t tell the real story about Anavex 2-73; which means it’s just not at all as safe or efficacious as presented. Investors are being hoodwinked.
3. Worse, all of the presented data, putatively supporting Anavex 2-73 efficacy comes from but 31 or so participants; a totally insufficient number of patients upon which to claim profound safety and efficacy outcomes. The trial was too short, and had no placebo or control arm; not the kind of deep, comprehensive clinical trial from which accurate and predictive outcomes can be derived. A few people dropped out of the trial, without explanation.
4. Alzheimer’s is extremely difficult to treat. Many other clinical trials with a number of proposed new drugs have been aimed at the disease, but in all but three or four cases, the billions of dollars spent in development and clinical testing has been for naught. The three or four drugs that have been approved for Alzheimer’s merely slow or stop disease progression for a relatively short period of time, whereupon disease progression resumes to inevitable lethality. Anavex is arrogant to believe its new, untested molecule, of very questionable mechanisms of action, can, somehow, bring relief to suffering Alzheimer’s patients. Billions of dollars have been fruitlessly spent by giant pharmaceuticals. Just what are the chances that little Anavex can solve this problem?
5. The company has but a handful of high-paid employees, owning large equity and options positions; all of whom will profit handsomely when they liquidate their positions before low-information retail share holders get a chance. Classic pump and dump stuff. No way these few employees can make everything happen for a successful pharmaceutical: product development, product manufacture, product sales, advertising, company management, intellectual property management and protection, and much more. None of that will happen.
6. The company is hyped by deluded and unknowing message board posters, who think Anavex Life Sciences Corp is the Next Big Thing, that the company will transform 21st-century medicine more so than antibiotics did in the last century; that an unknown plethora of diseases and conditions will respond to Anavex therapies. One bloke, a former high school biology teacher, has made utterly ridiculous conjectures on future AVXL share prices — but he makes errors and has misunderstandings of biostatistics. Anavex message board postings cannot guide appropriate Anavex due diligence.
******************
This summary has been presented to keep all of the likely victims from losing their investment shirts when, as the few knowledgeable commentators have projected, the company fails to gain FDA approval for any of its new drugs.
Glad to have been of service in compiling this due diligence summary.
(But it won’t impel me to sell off my small AVXL holding. I’m one of those low-information retail owners who is hooked on the company. I’m that biology teacher bloke. Kinda like pulling the levers on the machines in Vagas, eh? So exciting!)
Not A Solution, I Think
Falconer if Vitamin D helps many diseases including Alzheimers, I wonder if the drug called Rayaldee in combo with A 2-73 would possibly help. Rayaldee is a long acting form of Vitamin D designed by Opko health.
Not Questions That Should Have Been Asked
The rapid growth in dementia and many other diseases such as diabetes, and now with earlier onset, must have a cause. What do you, Falconer, propose that or those causes might be and are drugs the best or right answer?
Dementia Global — A Gigantic, Expanding Problem
What might be the market for Anavex 2-73, should it be approved for Alzheimer’s and other dementia treatments? Today, about 50 million have Alzheimer’s dementia across the globe. The numbers expand each year.
By 2040, up to 100 million will have the disease globally; with about 20 million in high income countries. Greatest growth of the problem, albeit severe everywhere, will be in the high population states in Asia, India and China.
The social costs (of every form) will be gigantic. Might those, sooner or later, prompt approval and administration of Anavex 2-73, should that drug exhibit even the slightest reduction in symptoms and their associated medical care and social costs?
There is no talk of any sort of thing just now, as there is presently no therapeutic solution to Alzheimer’s. At best, an expensive drug or two, with some sometimes severe side effects (Aricept, et. al.) slows the progression of symptoms for a while. Then, the disease lethally resumes.
Simply, the only hope for an Alzheimer’s solution is Anavex 2-73. The Australian study provided profound results in real people, those with mid to mild stage cases of Alzheimer’s. A number of Anavex naysayers have posted frequent cautions, claiming the known Anavex 2-73 efficacy data are entirely incomplete; that nothing can be acted upon until complete Phase 3 clinical trials appear next year.
Each must make his own decision on Anavex efficacy. Some may wish to wait for the completion next year of the final, authoritative clinical study. Others, including governmental health officials, might eventually wish to allow the drug in their countries, regardless of the regulatory status of the drug in the US.
Here’s a plot of the numbers:
https://www.alz.co.uk/research/statistics
The claim, here, is that Alzheimer’s will consume one percent of the entire global economy each year, about a trillion dollars, $1,000,000,000. There are about 41,000,000 AVXL shareholders. What, then, are the financial and tax savings motives for governments to gain some control on this? Could Anavex Life Science Corp offer at least a partial solution? If so, determine for yourself what that might mean to the company, in any number of several scenarios.
What fraction, if any, of the global Alzheimer’s problem might Anavex solve?
[This author advises that his postings should not be used to prompt any AVXL buy or sell decision. Anavex Life Sciences Corp is presently a small, no-revenues, no-product start up pharmaceutical. It may have a great future, as its science is unique and effective. But, of course, never put at risk any non-discretionary funds.]
BarChart Has Anavex As A Buy
BarChart has Anavex in its listing of stocks that its TrendSpotter has identified as entering a Buy Signal.
https://www.barchart.com/stocks/signals/new-recommendations/TrendSpotter/Buy?timeframe=current&viewName=main
https://www.barchart.com/stocks/quotes/AVXL
I don’t think this means much; don’t think it portends any big share price rise. Merely a favorable working of recent price and volume trends (or whatever internals BarChart uses) to signal a buy likely to appreciate in value.
Reactive Oxygen Species Not Favorable
Are ROS to blame for the protein misfolding?
Don't See Protein Involvement, Yet
I don't have any useful perspectives or understandings of how Anavex 2-73 might modulate or produce favorable proteins.
I'm not discounting the matter; merely that I don't see a mechanism that would produce proteins. If it happens, it's likely to be epigenetic, where an external force or molecule turns on existing genes, causing the production of the involved proteins. Just how Anavex 2-73 might epigenetically induce protein production, to me, is presently unknown.
Yes, We Must Be Careful About "Homeostasis"
My point is that homoeostasis can be interpreted as a catch all far broader perhaps than the reality of a compounds powers.
More Then Ca2 Modulation
In the case of A2-73 ‘Just’ calcium homeostasis, I believe.
I, Too, Hope To Be Wrong
The issue, of course, is the ability of nerves and nerve masses to re-grow, re-connect, and regain normal function.
Nerves and nerve tissues are famous for their general susceptibility to permanent injury or damage. The many with spinal cord injuries experience this. Paralysis too often results and never resolves.
Might Anavex 2-73, somehow, induce resumed growth of new nerves, and thereafter cause them to connect and self-organize into functioning nerve masses? Presently, I’ve seen nothing to indicate any of this. But all sorts of work, I’m certain, is being done on murine models in a number of labs. Some Anavex pipeline molecule might, somehow, be able to induce nerve re-growth and expanded function. It would be an epigenetic process, I believe, where the Anavex molecule would turn on the genetics of neurogenesis. Many animals are capable of this. Let’s hope an Anavex molecule can be made to induce the process for us “higher” humans.
Brain, Spinal Cord Similar, Same Sorts of Neurons
Is the brain composition different than nerves or are they close in their structure and composition?
Future Anavex Applications
The thought that Anavex 2-73 or other Anavex pipeline drugs might eventually have fruitful applications for the treatment or prevention of other CNS diseases or injuries is, yet, an entirely open question.
One important consideration.
Nerves don't "heal" quickly (if at all). Anavex molecules are unlikely to be a "Take this now, you'll feel better in the morning." sort of drug. Fixing nervous system anomalies will take time, perhaps months or years.
If there is physical injury, where nerve masses or brain regions have been injured, especially ischemically (no oxygen), healing may be very difficult, if actually possible.
We'll be watching lab discoveries as they appear.