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No Alternative
It's What I Do --- I'm A Teacher
Well, Psychotropics Are Prescribed
New Therapy Will Be No Better
The new therapy is merely a new way to clear or keep from accumulating toxic waste proteins. Fine and good, except....
The root problem is not the accumulation of the toxic waste proteins, it's their upstream generation, in the first place. That's where Anavex 2-73 is so different and so much more effective. It allows the neuron to properly and normally fold proteins in the endoplasmic reticulum. With that, yielding folded, functioning enzymes, waste proteins are properly processed and lyzed (chemically pulled apart) into more elemental factors that are properly re-used or excreted. No toxic accumulation. Normalized nerve function.
Infused Alzheimer’s Therapies Won’t Work
Here’s a report from Europe claiming two problems with treating Alzheimer’s patients there. First, trained diagnosticians in short supply. More people will get Alzheimer’s than can be properly diagnosed.
But worse, with approval of any of the anticipated Alzheimer’s drugs that are infused (injected through a needle), there aren’t enough infusion facilities to accommodate the large number of patients.
A Non-capitalist Model
Billions, Only.
If So, Great!
The Science Notwithstanding; Only Trials Data Will Control
Nice little share price bounce today. Volume will be around 3x recent.
But none of what we watch and have seen here (CTAD, other presentation announcement, etc.) will much change the general market’s perception (or knowledge) of Anavex Life Sciences Corp. Yes, the science is ever stronger, with no plausible or evidence-based refutations. Multiple sclerosis now ever more in play. An understanding of cellular chemistry and physiology reveals that the Anavex sigma-1 receptor agonists promote healthful outcomes for a multitude central nervous system diseases and conditions; and others. Simply put, Anavex 2-73's therapeutic applications will be diverse and profound.
But the fact remains—the Anavex share price does not appreciate much with even announcements of good science. The market, in fact, cares not a whit about the science. Equity share prices of biotechs are not based at all on the validity of underlying science. Only one thing counts: can the company reap profits from its technologies? The market is not dumb. Revenues can’t accrue until regulatory approval for drug sales is attained; as with the FDA in the US, and similar regulatory agencies in other jurisdictions.
And no approvals will occur until positive clinical results appear, either during a trial (numerous anecdotal leakages), or with formal end-of-trial results. Until either of those, I’m not expecting the AVXL share price to attain any generalized recognition. In a few months, it could double, perhaps. But the revenue potentials for approved sales of Anavex 2-73 will put the eventual share price into triple digits.
Until human trials results appear, the AVXL share price will be but a temporal curiosity. But in time, the profound science will prevail. “Anavex” will be heard in general conversations. Waiting patiently for all of that.
US Annual Cost of Sleep Deprivation $411 Billion
The Placebo Effect
Of course, there's a one-third chance the scientist in the Aussie trial ends up taking a starch pill. With that, he experiences no symptomatic relief, so Anavex 2-73 will be an Alzheimer's treatment failure (until all end-of-trial data are crunched).
Is This The First?
Is this the first mass-media report of Anavex 2-73 as a credible new Alzheimer’s treatment?
www.abc.net.au/news/2018-09-25/alzheimers-disease-research-questions-plaque-as-cause-of-disease/10299514
It’s merely a report, down under, telling that a well-known, award-winning scientist will participate in the Australian Anavex 2-73 trial, against the man’s Alzheimer’s disease. By itself, the thick, unmoving sludge of Alzheimer’s treatment perceptions will not be much changed. But what happens to the popular perception and recognition of Anavex when more, similar articles appear?
Thanks TTTav66 for posting this most interesting (and important) link.
But, What, After the Big Money?
There Is No Anavex Disappoint Whatsoever — Mere Ignorance
Ariana Stakes Its Validity on Anavex
Big Market Developing --- Americans Aging Out
Just saw this, by CBS:
New Adverse Effects, Side Effects?
I'm very interested in learning also the occurrence of side effects in those who have been taking Anavex 2073 for 2.8 years. Do side effects increase, stabilize, or decline with long-term use of the drug?
The only concern, of course, would be that side effects appear more frequently and more severely with continued, lengthy dosings. If not, if side effect occurrences did not increase in frequency or severity; or better, if they actually decreased, the safety factor is positive and cannot negatively affect approval of the drug. The only remaining factor would be efficacy---which the presentation title strongly implies to be favorable.
For those who have forgotten, approval for commercial sales of the drug (at least in the US) requires two things: a) demonstrated safety, and b) demonstrated efficacy equal or surpassing existing drugs or therapies. Inasmuch as there are only four approved Alzheimer's drugs, all of which have meager, non-persisting benefits (they merely slow, for a time, the lethal progression of Alzheimer's), the Anavex drug hasn't much to eclipse. The competition is very weak.
From the presentation title, it appears that Anavex 2-73 exceeds existing drug efficacy, by stabilizing (or even perhaps reversing) cognitive decline. The standard of care hurdle Anavex has to leap is extremely low. Nothing in this presentation announcement even hints that won't be exceeded in the being-arranged clinical trial.
Reality Requires A Clinical Trial
The Cautionary Objections
I’ll start. Here’s some of the “objections” that will be, once again, so forcefully laid out for us; keeping any of us from thinking Anavex has a real future.
1. 148-Week Extension Study for ANAVEX®2-73 Phase 2a Alzheimer’s Disease Demonstrates Maintained Activities of Daily Living Score (ADCS-ADL)...
Well, so what, it will be claimed. “Daily Living” doesn’t tell much. People will want a more thorough therapy. Not promising at all; just some patients feeling a bit better from time to time. Bogus, of course.
2. Reduced Cognitive Decline (MMSE) for Patient Cohort on Higher Drug Concentration and Confirms Role of Patient Selection Biomarkers
See, no real Alzheimer’s turn-around, just slightly reduced cognitive decline. And only on the very few taking higher doses. Not really a big thing, it will be claimed — if it’s even accurate.
And, the good stuff happened only in the few with particular “biomarkers.” A drug of narrow patient population parameters.
3. Keep in mind the woefully low number of tested and assessed patients. The world has millions with Alzheimer’s. The slightly positive outcomes of just a few Australians can’t possibly reveal anything of therapeutic significance.
But, on the other hand, I’ll note the following.
1. Actually, quality of life, the “daily living score,” is for relatives and care-givers the most important Alzheimer’s factor. If Aunt Matilda can continue each day to dress herself, feed herself, bathe, and stay safe, she’s far better than her friends with typically progressing Alzheimer’s.
2. 148 weeks is 2.8 years. How many Alzheimer’s patients go for that period without cognitive decline? In that period, these Australians actually revealed a reduced cognitive decline. To attribute that to mere chance is statistically ludicrous.
3. The data to be presented affirm my contention that the ability of Anavex 2-73 to restore normalized neuron biochemistry is likely to persist with appropriate and continued dosing. Simply, Anavex 2-73 (in the approximately 80% with favorable genetics) at least terminates the conventional and expected progression of Alzheimer’s disease.
4. If Anavex 2-73 stops the symptomatic progression of the disease when first administered, what are the implications of being able to prevent progression to levels requiring institutional care? What if Aunt Millie starts taking Anavex 2-73 when she first forgets where she left her car keys, but otherwise still continues to live a normal life at length thereafter?
5. Does any of this meet or exceed the existing standard of care Alzheimer’s drugs?
----
Is anyone wondering, now, why the Aussies elected to continue to take the drug after the formal clinical trial ended so long ago? What were they thinking? (Pretty well, in fact.)
Implications Of Anavex 2-73 Sleep Facilitation
Anavex Therapies Will Be Expansive
I'm Holding Until Trials End
The clinical trials will tell, won't they?
For most of us, the crucial matter is whether or not any of the Anavex molecules gain regulatory approval for sales and patient use. Investment in AVXL shares at this point must be controlled by what one believes will occur in this regard.
I, and most other strong longs, have weighed the existing information on the Anavex sigma-1 receptor agonists and are confident that the required human trials will produce the same clinical results that have occurred in transgenic Alzheimer's rats. Given the existing in vivo and in vitro studies on the Anavex sigma-1 receptor agonists, we see no reason whatsoever that, somehow, human neuron organelles will fail to respond as do those in murine neurons.
Of course, each potential or existing AVXL investor must decide for himself if holding any Anavex equities is advisable. The information I've presented is not intended to and will not dissuade the reluctant. It is merely to lay out the sound basis of my Anavex investment --- to be validated or negated by the upcoming clinical trials. They will reveal the controlling truths. We must wait.
For Your Information — A Study Exists
It was claimed, “I have seen no models in which 2-73 outperformed ANY other Alzheimer's therapy.”
Ignorance of such studies is not evidence of their non-existence.
In fact, as reported in a peer-reviewed journal article, a detailed study of an Anavex sigma-1-receptor agonist, an analogue of Anavex 2-73 in transgenic rats with human (not rat) genes for Alzheimer’s, revealed extremely positive therapeutic outcomes — ones that exceeded any existing Alzheimer’s therapy.
The Trials Are Merely Pro Forma
Murines Have Neurons Virtually Identical To Ours
Failure of All Three Clinical Trials
Which Share Price Is More Important?
Certain parties express either concern or delight with the current AVXL share price. Does it matter?
Which is more important, today’s (or next month’s) share price; or what it will be in, say, five years?
Of course, for short-term momentum players or day-traders, present and near-term AVXL share prices are the only ones that count. For those folks, AVXL isn’t much of a money-maker.
For others, those of us who, on the basis of the unique science of the Anavex molecules, coupled with both murine (lab rodent) and existing human clinical trials and the utter lack of any presented contrary evidence, believe the real value of AVXL will appear in a number of years; after any one of the three clinical trials shows profound safety and efficacy, followed by widespread, even global clinical use against central nervous system diseases.
Sorry for the short-termers. No prospect of any AVXL share price ascent in the next several months. Most likely, no appreciable share price changes until, at least, sometime in 2019, with either the appearance of multiple personal accounts of efficacy among clinical trial participants (multiple leaked positive outcomes), or after complete clinical trial results are published.
But even with any of that, the ultimate, continuing, stabilized price of a share of AVXL won’t be seen until Anavex Life Sciences Corp reaches saturated global sales levels. That could be five years from now.
We Anavex long-termers chuckle a bit when reading the so-many postings of AVXL share price alarm. We aren’t looking at today’s share price, nor values in the next weeks or months. Our perspectives are years in the future.
Let’s compare notes in, say, 2023. Who will have had the greater annualized gains?
Prohibition of Waste Proteins the Better Outcome
Listed Price Way Up There (in Canada)
Presently, Toronto Research Chemicals lists a 50mg dose of Anavex 2-73 at $400 (USD).
Certainly lower prices will prevail when in massive, continuous production, as for the upcoming trial in Australia where 300 patients will be treated daily.
But, if I wanted it (and were allowed; am not), a week’s worth of the stuff would set me back $2800.
Eventually, chemical engineers will step in and devise much cheaper mass production of the molecule.
A Seasonal Correlation
It is claimed or noted that in temperate latitudes (as in Europe or North America, opposed to tropical regions) cognition may be lower in winter and spring; strongest in summer and fall. How so (if so)?
Ponder this information.
Slightly more Scots get multiple sclerosis than Londoners. Slightly more Londoners (percentage-wise) get MS than residents of Madrid, Spain. In tropical India, among people not covering most of their bodies with clothing, MS is rather rare.
Those living at higher latitudes have increased rates of MS. And it has nothing to do with cooler temperatures up there. It’s sunshine.
Well, not sunshine per se. Except above the arctic circle, the sun shines every day in all of the locations mentioned. But there are two essential differences: sun angle, and sun duration.
The sun angle factor is this. In India, each day the sun rises high in the sky. Sunlight passes rather directly to the earth’s surface. But in Scotland, say in March, the sun rises to less than 45 degrees of angle in the sky. That changes everything.
And so does the fact that in sub-tropical India, the days in winter are only slightly shorter than days in summer. Not so in Scotland. Winter days are short, nights are long. The obverse in summer.
What does any of that do with either seasonal cognitive decline or multiple sclerosis? It’s vitamin D.
In fact, vitamin D is not a classic “vitamin.” In fact it is an essential hormone, photosynthesized by sunlight striking naked skin. And not just any sunlight. Synthesis of vitamin D requires ultraviolet B (UVB) radiation in sunshine. Big thing is this. The atmosphere absorbs UVB to a degree. When the sun is high in the sky, as in summer, or at mid day, the UVB spectra pass through shorter length of atmosphere. Conversely, when the sun is low in the sky, as in winter or late afternoon in summer, the light angles low through the air, and most of the UVB is absorbed; doesn’t strike the skin — can’t make any vitamin D.
In fact, human skin can’t make any vitamin D when the sun shines at an angle less then 45 degrees above the horizon. If your shadow is longer than your height, you will make no vitamin D.
Which means that those living in temperate areas, virtually no vitamin D can be made in late fall, all of winter, and early spring. In those periods, the body has to rely on vitamin D reserves stored in fat. But by winter, those run low, so vitamin D deficiency sets in; with a host of untoward outcomes: including reduced cognition, and greater vulnerability to multiple sclerosis.
Of course, antiquated legacy perspectives of vitamin D will claim authoritatively that the vitamin merely moderates proper calcium use in the body, preventing rickets. Nothing more. But, as with the discovered science of Anavex sigma-1 receptor agonists, vitamin D deficiencies have been shown to affect a multitude of human diseases and conditions, including multiple sclerosis.
The Bigger Story
Verbal Detection of Early-stage Alzheimer’s
A team of researchers from the University of Miami Miller School of Medicine is devising a rather simple verbal, word-selection and word-use test that appears to identify prodromal (early-stage) Alzheimer’s disease; before more severe, classic symptoms appear:
ALS, Too, Caused By Misfolded Proteins
A new report shows that amyotrophic lateral sclerosis (ALS, “Lue Gehrig’s Disease”), like other central nervous system diseases, is caused by misfolded proteins:
Not a Therapeutic Competitor
The liver disease drug ursodeoxycholic acid (UDCA) appears to offer a new therapy for both Parkinson’s and Alzheimer’s. It relocates a protein called "Dynamin-related protein 1" (Drp1). With this, it apparently re-configures distorted mitochondria, allowing them to more functionally produce ATP, the near-universal power-supplying molecule in cells. With adequate ATP, cells can function normally.
Except when endoplasmic reticula are misshapen or otherwise functionally compromised. For full cellular function, cells need not only adequate supplies of ATP to power their chemical reactions, they need precisely-folded proteins (enzymes) that mediate, control virtually all biochemical reactions (including those that clear the waste proteins associated with Alzheimer’s). The Anavex sigma-1 receptor agonists restore proper, functional architecture to both mitochondria and their associated, connected endoplasmic reticula.
So, yes, if this existing liver disease drug can prompt mitochondria to produce more ATP, malfunctioning nerves cells in both Parkinson’s and Alzheimer’s might be somewhat improved. But without properly re-connecting mitochondria and endoplasmic reticula, thereby restoring normalized biochemistries in both organelles, enzymatic deficiencies will continue unabated; the diseases will be, at best, only moderately suppressed by the liver drug.
I looked up the reported side effects of the drug. Lengthy; some mild, others severe. Several pharmaceuticals retail the drug. I won’t be buying any of their equities. Anavex has the far better Parkinson’s and Alzheimer’s solution (in the future).
https://www.drugs.com/pro/ursodiol.html
Well, Wasn’t Going To Mention Nurses....
Grandmother Will Be Silenced?
Really?
Share Price Will Languish — Until....
Most of those with dollars to invest in young, start-up biotechs (or any other sort of equity firm) are aimed at just one thing. Increase the value of the investment in a particular equity. Dollars in, then increasing dollar value, from the start, without interruption. With thousands of equities to buy, why buy and hold some stock that simply sits there or declines for weeks and months on end (as in the case of AVXL)?
Many here are knowledgeable of the profound, revolutionizing science of Anavex Life Sciences Corp. We have confidence that, in time (probably longer than hoped), Anavex drugs will get approved and their consequent global sales will reap wonderful gains for us.
But for most “out there,” the science is incomprehensible or altogether questioned. Drug approval procedures and time lines mean Anavex Life Sciences Corp can’t be making any money on their proprietary molecules for at least a year; probably several years from now (if ever).
The majority of equity investors will quickly turn away from even thinking for a moment about buying any AVXL shares. Simply and succinctly, just not worth it. Compared to hundreds (well, thousands) of other stocks that are ascending in price along with the general market, AVXL would be an unwise investment. Until actual clinical results appear, showing applicable efficacies against any of the three diseases being tested, there is no plausible reason the AVXL share price will appreciate to any rewarding degree.
Until positive efficacy news of some sort appears, the AVXL share price will not be attention-getting. Up a bit, perhaps, from time to time, but no chance of a steep, sustained order of magnitude appreciation. That’ll happen, but only after positive efficacy news appears.
Until then (my main target year is 2023), gonna be pretty boring here.
I Don't Know The Answer To This: