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MIT Press Publishes Alzheimer’s Research Book
https://mitpress.mit.edu/books/how-not-study-disease
The author, Professor of Neurobiology and an Investigator in the Alzheimer's Disease Research Center at the University of Pittsburgh School of Medicine, gives an inside view of Alzheimer’s research and the continuing search for a “cure.” (No indication that Anavex is mentioned.)
Wha happend?
How come the big share price rise, starting at 2:30pm?
Side effects written, not spoken.
Anavex revenues.
Blarcamesine TV ads.
No problems with blarcamesine information or sales. Easy.
Eventually, Anavex in all EMS vehicles?
Another Anavex CNS indication — stroke.
Interesting paper. Wish I could read the whole thing.
But it’s an Elsevier publication. That publisher charges for access to entire papers, beyond the posted abstract.
https://pubmed.ncbi.nlm.nih.gov/34582837/
First, if sigma-1 receptor activation does alleviate the blood–brain barrier disruption caused by cerebral ischemia strokes, there is a gigantic market for this; and hundreds of thousands to millions of stroke patients would benefit profoundly.
But, because I couldn’t read the actual paper, I could not read the details of how this was determined. What was the specific sigma-1 receptor agonist used in the study? Could it have been as good as blarcamesine or Anavex 3-71? What was the dosing regimen? What were the therapeutic results? How were they assessed?
Once again, yet another CNS disease or condition ameliorated by sigma-1 receptor activation. So far, no other drugs have matched the safety and therapeutic outcomes of blarcamesine or Anavex 3-71.
Let’s now see a clinical trial with our drugs, for ischemic strokes; first, as in this study, in mice. Then, real humans.
A candidate family of blarcamesine rare diseases.
As I’ve contended before, there is a group of closely-related rare diseases for which blarcamesine is very likely to be profoundly therapeutic, even prophylactic.
As a biologist, I’ve studied these closely. I, personally, have one of the diseases.
The family of diseases are those included in HSP, hereditary spastic paraplegia (of which there are a wide diversity of genotypes and phenotypes), and primarily lateral sclerosis (PLS).
In all of these, neurons fail to function properly. Most often, neurons controlling muscles (motor neurons) become hyper-excited, firing often, strongly, or continuously. That causes the spasticity, the continuing contraction in various muscles.
Personally, I have a very mild, late-onset version of HSP—which, in fact, was not hereditary. Many cases of HSP are actually spontaneous, not genetically inherited; merely an incidental mutation. Neither of my parents had HSP, and neither of my children inherited it; thankfully. In my case, the motor neurons controlling the adductor muscles of my legs (and a few other, minor ones, especially in the bladder—now have a suprapubic catheter) are continuously taught. I can walk, with a walker; am able to drive a car very safely and effectively; but couldn’t operate a stick-shift car. Can no longer ascend stairs.
For those with more severe HSP, a rubber bladder is surgically implanted the spinal column. It exudes into the nerves controlling the legs gamma-aminobutyric acid (GABA). This is the chemical missing in the affected motor neurons. GABA is an important (well, crucial) suppressor of nerve over-activity, hyper-excitability. When deficient, nerves fire too easily, causing all sorts of end-of-nerve anomalies.
My case of HSP is not bad enough to prompt the intense surgical procedure of implanting the rubber bladder in my spinal cord, thankfully. My case does not seem to be advancing, thankfully.
Here’s where blarcamesine will come into play with probably all forms of both HSP and PLS. In virtually all cases, neurons are lacking proper, effective concentrations of GABA; hence the over-excitability of the nerves. It was noted in the early findings of blarcamesine against Rett syndrome, in the early safety/tolerability study, that levels of GABA were dramatically increased, normalized by the drug; yielding increased normalization of motor neuron function.
Many years ago, there was a small study of blarcamesine included in the drinking water of lab rats with HSP genes. Like myself, they had reduced control and function of their spastic rear legs. Then, after they drank water with some blarcamesine in it, they rather promptly (in a week or two, as I recall) regained complete motor control of their leg muscles and twirled inside the exercise wheel like normal rats. Blarcamesine (Anavex 2-73) completely obviated the GABA deficiency, allowed normal walking. A cure, dare I say.
(Two years ago, my computer hard drive crashed; I lost the copy of that report; which I believe was in France. I’ve been unable to find it on the internet. If anyone can retrieve it, please post.)
A rare disease? Yes. “The HSP incidence rate in the United States is about 20,000 people.” But for many, very tragic, in the most severe cases:
https://sp-foundation.org/understanding-pls-hsp/hsp.html
When available, I’ll be one of the first to take blarcamesine, off-label, for my HSP. Will be rather expensive, my health insurance won’t pay for it. May have to liquidate a few AVXL shares, then.
Blarcamesine does this.
My Schwab Account Says I Gained
Schwab says my several thousand shares of AVXL ended the day, up 2.61%.
Which “Precision Medicine?”
Wall Street Week and Nova, on PBS
Thanks. Perhaps so.
Impact of new AVXL share sales.
Ok, Anavex is announcing that it intends to raise $150,000,000 by selling new, created AVXL shares. This, of course, will reduce the relative value of each existing, earlier Anavex share. More shares against which any sort of value must be divided, whether in eventual dividends, or any other calculation.
Pretty distressing, yes? I’ve got a few thousand AVXLs in my brokerage account. After Anavex collects it’s targeted $150 million dollars, what might that mean for the value of my shares. Let’s see. (Spreadsheets wonderfully allow these calculations.)
The first number to enter, at the top left cell, is the number of existing AVXL shares, in trade. My Schwab account says there are 75,710,000 of them right now. To get it’s $150 million new dollars, Anavex will increase the number of shares in trade. How many will that be?
In a new column I entered potential share prices for the new sales. In the first, top cell I entered $20. Next cell, $25, etc. These were the new share sales prices I punched in:
$20
$25
$30
$40
$50
$75
$100
$125
$150
$175
$200
Then, how many new shares, at each of these prices, would be sold (to yield $150 million)? These:
7,500,000
6,000,000
5,000,000
3,750,000
3,000,000
2,000,000
1,500,000
1,200,000
1,000,000
857,143
750,000
Lastly, what would be the percentage increase of total shares, at each of these sales prices:
9.91%
7.92%
6.60%
4.95%
3.96%
2.64%
1.98%
1.58%
1.32%
1.13%
0.99%
In summary, at the worst case (at a new shares sales price of around $20), there will be an approximate 10% increase in the number of Anavex shares in trade. If they can be sold at $200, the increase will be about 1% of new shares.
For my AVXL position, of little or no impact. I’ve only a few thousand shares. For Anavex CEO Dr. Missling? How many hundreds of thousands of shares does he own? Is he jeopardizing the value of his holdings by this proposed sale of $150 million worth of additional shares? I think he’s got it covered, that overall, both the company and its shareholders will eventually benefit.
Another Anavex Clinical Research Week Has Passed
Of course, no announcements or data from any of the three on-going clinical trials that will ultimately demonstrate blarcamesine's safety and efficacy for a) girls with Rett syndrome (this is not sexist; boys who inherit the disease’s genetic anomalies die before birth), b) people suffering from Parkinson’s disease dementia, and finally, c) a statistically sufficient number of people with Alzheimer’s disease.
No results data yet that we can see. But those data are continuing to accumulate, nonetheless. None of the three clinical trials have been halted; patients continue to be dosed with blarcamesine, and the clinical results of the drug continue to be accurately and precisely assessed. When each of the clinical studies are complete, and their therapeutic result data points are properly crunched (with detailed statistical analyses) the information will be made public; to be seen and considered by one and all.
First, with profound consideration of the clinical results, will be both the blarcamesine patients and their families and care givers; revealing whether or not the drug will continue to be available.
Next will be both medical science and investment news writers. These “smart people” will have to interpret for the general public just what the blarcamesine results might mean; whether or not they hold any promise.
Lastly (but quite importantly) will be us; those of us who have taken and hold AVXL equity positions. What we’ve been expecting for these many years will, finally, start to become reality.
Until then, everyone must just wait. Biochemical processes can’t be hastened by external mental hopes or imaginations. Blarcamesine-activated sigma-1 receptor proteins will function at their own pace.
The putative SAVA/AVXL share price linkage.
Why I don't day-trade.
Ok, around 10am this morning, after seeing a nice AVXL share price rise, considering what I've seen so often before, I made the claim, "Time for the day-traders to start selling off their trading positions. Will have a nice one-day profit."
Sure.
Then, of course, the share price continued right on up, from the 6% gain around 10 am on up to the gain of 9.41% at the close. Had I cashed in a few hundred of what would have been my "trading shares," I would have missed another 3% gain --- and if the share price continues to rise (very likely), I'd never be able use my 6% profit to allow me to take an expanded, new position.
I'm better off having just sat all day, watching the day's momentum move.
This confirms: I'm not, should not try to be, a day-trader. I'll let others play that game. I'll just watch them. My best wishes.
Stock Advisor Recommendations Now At Play
As always, a very informative posting, RedShoulder.
These are just the first investor advisory postings more accurately telling both the sound science of the Anavex drug, and how it will treat large numbers of people. There will be more and more of them.
I, too, use the Charles Schwab brokerage, and was delighted to see this headline on my Schwab screen this morning: --BTIG Starts Anavex Life Sciences at Buy with $35 Price Target.
I notice also that Schwab now posts a B investment grade on Anavex, meaning "Outperform." Formerly, none was posted (the Schwab grade scale: A, B, C, D, F).
The word (of the Anavex science) is finally getting out, being understood and applied to understandings of how it will work for the AVXL share price.
As I've contended before, the first giant, irrevocable thing that will propel the Anavex share price will the article in the New York Times, "New Drug Shows Promise for CNS Diseases." That should be right after the FDA approves blarcamesine for Rett syndrome; based upon all of the existing safety and efficacy data, that will surely happen.
For AVXL shareholders (and CNS disease patients), 2022 is going to be quite a year.
Basis for taking an AVXL position.
Interestingly, there are a number of divergent, otherwise unconnected reasons, I see, that equity buyers have or might decide to take an AVXL position.
1. The Investment Advisor Recommendation. In this case, a recommendation in some investor newsletter, blog, or webpage prompts an AVXL buy. The particular reasons the newsletter or investment advisor states are not as important as the recommendation itself. It comes from “someone who knows,” or has “a good record.” Good enough. “I’ll buy some of those.”
2. The FOMO (fear of missing out) Buy. In whatever way, an equity buyer discovers that, at least for the nonce, the AVXL share price is on a steep ascent. The person wants to catch that rise, so “buys low, to sell higher.” Few or no other data or information come into play.
3. The Day-Trading Play. It is noted that the AVXL share price tends, at times, to sharply ascend, then more slowly drop back to some “base price,” Day traders, expert in spotting and playing these moves, go in an out of AVXL positions, making a few percentage points of gains with each buy/sell trade pair.
4. The Technical Analysis (TA) Play. Those confident in TA see and act on various TA buy or sell signals. Trades are based solely on the AVXL or market TA charts and metrics; nothing else.
5. The Anavex Science and Potential Markets Play. AVXL positions taken with these criteria take into consideration the accuracy, validity, and potential applications of the existing, known ANAVEX science, as revealed in scholarly papers, informed postings, research, and corporate and institutional announcements; while also considering the potential markets for the ANAVEX drugs, once they might gain regulatory approval for sales and therapeutic uses.
Each of these will prompt varying time frames in which AVXL positions might be retained.
In Number 1, Investment Advisor Recommendation, positions may be held for some time, contingent on when the recommendations are to play out. Those are likely months or years.
In Number 2, the FOMO Buys, rather short term, for most. When the price ascent levels, time to take the gain and find another equity moving up rapidly. Of course, for some, the AVXL position is then retained for longer-term gains.
Number 3, Day-Traders, are in and out, often within minutes or hours. Nothing long-term here.
Number 4, TA Analysis plays, are probably a bit longer than day-trading. The charts decide.
Number 5, the Anavex Science and Markets plays, are decidedly long-term. Buy, and hold. Wait. Payoffs somewhere in the future; but particularly rewarding when they eventually happen.
Personally, my few thousand shares of AVXL have been purchased, and are retained, because of Number 5, the science and potential markets of Anavex Life Sciences Corp. I utterly reject all of the others, find nothing useful about them at all. But, I dully respect the many individuals who post messages on each of these. I read, and consider them all (but don’t act on any except the science postings). All good people, here; making this one of the most informative iHub message boards.
Time for profit-taking.
It's 9:59am, I see the AVXL price at $18.70, up 6.01% for the day.
Time for the day-traders to start selling off their trading positions. Will have a nice one-day profit.
Don’t want to “pump.”
Spilled beans not on the investor’s menu.
Keeping track of the zeros.
Detection? Prophylaxis? Or Treatment?
There continue to be, from time to time, reports of new methods or procedures that promise to accurately detect Alzheimer's dementia before gross symptoms conventionally reveal the disease. Well and good; except....
Except for the fact that presently, such a diagnosis can offer no useful consequent therapy. Presently, there is very little that can be done to slow or minimize the onset of Alzheimer's disease. Simply (tragically), an Alzheimer's diagnosis is lethal. No one, ever, successfully stops the disease's lethal progression. Yes, Aricept, one of the very few drugs approved as an Alzheimer's therapy, can, for a time, slow the disease's progression. Nonetheless, at some point (sooner than desired) the disease's dementia progresses severely. A morbid death always ensues.
(I know this personally. My father, an accomplished and successful public accountant, had early-stage Alzheimer's; was admitted as a patient in the clinical trial that eventually allowed the approval of Aricept. Whether he was in the control arm of the study, taking a disguised starch pill, or Aricept itself, was never known. Didn't matter. He declined rapidly; was committed to an Alzheimer's care center, where many month later he died.)
I tell, once again, that probably blarcamesine's greatest therapeutic utility will be not just to treat existing Alzheimer's cases (very successfully) but, in fact, to prevent the disease's onset; used as an Alzheimer's prophylactic.
Interestingly, the recent Anavex patent for blarcamesine (Anavex 2-73) patented a dosing regimen where the drug would be given to potential Alzheimer's patients (meaning anyone and everyone in their forties or fifties), for prophylactic, preventative purposes. But it was noted that this proposed (and now protected) dosing regimen would be intermittent. The drug would be taken for short periods of time, say, for several days; followed by an equal or longer no-doses period. This is a new on/off dosing schedule. Anavex must believe, have evidence, that this will be successful.
It makes sense, because when blarcamesine binds, as a ligand, to the sigma-1 receptor protein, it can then remain attached for some time, modulating and promoting the many propitious things that happen when that protein is properly activated. No apparent need for continuous, uninterrupted dosing. Blarcamesine pills on, say, Mondays and Tuesdays of every week may be fully prophylactic.
Instead of new early Alzheimer's detection protocols or methods, as good as those will be (very much invited), the biggest Alzheimer's story, when it can appear, will be news that intermittent dosing with blarcamesine soundly prevents the onset of the disease.
The other, earlier Alzheimer's news will be the clinical realization that blarcamesine can actually reverse and stop the progression of Alzheimer's.
No other drug, or pharmaceutical company, will be able to exhibit these two profound Alzheimer's therapies: a) effective prophylaxis (prevention) of the disease, for people who don't yet have it, and b) effective treatment for those who do.
A new era in neurological medicine.
Thanks.
I did a quick scan-through of the paper; couldn't find any references to the sigma-1 receptor protein.
How, do you think, this paper involves or might be affected by blarcamesine?
Very definitive. Blarcamesine is safe, and works.
Woke up this morning, turned on my desktop computer to see what appeared this morning. Saw that Anavex has put up a new presentation. Clicked on it, and, wow. Pages of data (didn’t see a single datum from a mouse or rat).
I wanted to check the following:
A) Solid evidence of efficacies against listed, targeted CNS diseases — lots of it.
B) Are the efficacy data points statistically significant (p = <0.05) — p-values all very low; profound statistical significance; results not by chance or placebo effects.
C) What diseases and conditions are being targeted — nothing new there; just a broad range of giant CNS diseases, of expansive, global importance and occurrence.
D) What are the side effects of blarcamesine in any and all of the presented studies — virtually none; unique for a drug acting in the CNS.
Of course, most common retail equity investors couldn’t (or wouldn’t) parse out the confirming data. They are still in the dark about Anavex. They will wait to read of FDA approval in the New York Times. I’m not expecting any stout AVXL share price rise today.
Others? Well, anyone with even a low undergraduate level of biological knowledge should be impressed. The data speak for themselves. Blarcamesine is safe, is administered orally in low doses, and in a variety of CNS diseases facilitates, promotes, and causes very significant therapeutic improvements. The molecule works; like no other.
As always, contrary views of the presentation are warmly invited. Please tell, how does this fail to tell the Anavex story?
The biggest Anavex story: blarcamesine prophylaxis.
Placebo stuff again?
Won’t work; not a med-school professor.
Real price catalyst will be NYT article.
Let watch, by the end of 2023.
Oh, no new CNS drug can work?
Pretty generic hopefulness.
AVXL. Now, or later?
My numbers, too.
The other big Anavex application.
Such great potential, for a severe condition.
The errors were not Missling's.
Info errors. But data very promising.
This was a claim in today’s fragile X announcement: