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Prodromal, prophylactic therapies; blarcamesine and Anavex 3-71.
Right now, it appears that about 20% of American Alzheimer's patients have genetics (or other innate factors) that preclude effective therapy with blarcamesine. Current evidence suggests the drug will be effective for only about 4 out of 5 Alzheimer's patients. Any hope for the others?
Two things, presently, lack evidence (in humans). Could blarcamesine provide useful therapy, keeping Alzheimer's from progressing to any stage of debilitation if it were administered prodromally, before any frank, obvious symptoms appear? As noted before, there are several new tests to determine the prodromal presence of, or susceptibility to eventual Alzheimer's disease. With those tests, middle-aged individuals could be tested in their annual health checkups, and if indicated be treated with blarcamesine before symptoms set in. Yet untested is the notion that early, prodromal administration of blarcamesine could actually slow or prevent the onset of Alzheimer's, even in people with genetics otherwise unfavorable to blarcamesine. The concept of prophylaxis.
Secondly, perhaps even more significant — yet to be tested — will be how Anavex 3-71 might work as both a prodromal prophylactic (pre-symptomatic preventative), or, for the 20% with genetics unfavorable to blarcamesine therapy. Might this other Anavex sigma-1 receptor agonist not be restricted to only the 80% with blarcamesine-favorable genetics. Anavex 3-71, at least as to effective doses (in micrograms, not milligrams; doses lower by a factor of a thousand) is very different from blarcamesine. For Alzheimer's of all genetics, perhaps more effective than blarcamesine.
Important matters yet to be checked in clinical trials.
My pricing powers.
I was delighted to be able, once again today, to push the AVXL share price higher in the afternoon, closing at nearly the high of the day.
Today, my brokerage received the new funds I had my bank send to them, from my savings account (from my discretionary funds; can afford to lose these if it happens). I was eager to buy a few more AVXLs.
But, being an astute student of typical share prices during recent days, I noted that for some time, on most days, the AVXL share price ascends before noon, then settles back in the afternoon, sometimes lower than the previous day's close. Seeing that, I intended to buy my new shares in the last hour of trading today.
But, nope, the market perceived my plan and thwarted it. The price kept ascending all afternoon, presenting no desired, lower-price buying opportunities.
Be advised, next week I'll continue with his buying strategy; looking for a late-day sell off. If that doesn't work, I'll simply congratulate myself on how this strategy actually powers the share price ever higher.
At some point, in desperation, I'll take my new position, after which the market will then drive the share price back to around $5 or so.
No matter. In a few months I'll be way ahead with all of my AVXL purchases. In the interim, what pricing powers I have!
Not so.
But, this wasn't one of them.
BIG ERROR. Disregard my previous post. I had the wrong number of outstanding AVXL shares. Those are 60,191,000, not 60,191.
So, lets run the numbers again, but with the real outstanding share count.
Because Anavex may soon gain authorization to sell blarcamesine as a recognized therapeutic drug, what might be the involved numbers? With recognized and inherently questionable suppositions (but now with actual number of outstanding shares), ponder these projections (which are offered for only the sake of curiosity; not in any form as investment advice).
First, let's select the number of patients that, in some time, will be taking blarcamesine. Let's take that total number to be 10 million patients each year, some time in the future.
Good enough. Very reasonable.
Now, big question. What will be the daily cost of blarcamesine therapy? I'll presume Anavex Life Sciences Corp will sell the drug for $2 for each day of treatment. For a year, that's $730, from each treated patient.
10 million patients each spending $730 each year on blarcamesine brings to Anavex Life Sciences Corp a total annual revenue stream of $7,300,000,000, $7.3 billion.
Presently, there are 60,191,000 AVXL shares in circulation. If that number holds into the future (likely will be higher), each share would represent $121.28 of the total annual corporate income.
Now, for those of us who hold an AVXL position, owning some of those shares, the big question is what fraction of that 121 dollars ends up as an annual dividend? Each reader must decide.
Then, from that presumed dividend, extrapolate a likely AVXL share price. A good number of zeros to keep track off.
Those numbers too big? Ok, presume that only one million patients will take the drug worldwide. Then, to be really safe, presume Anavex charges just a dollar for a day's dosage. With those extreme low-end numbers, corporate revenues would be only 365 x 1 x 1,000,000 = $365 million in annual corporate revenues. Spread among the 60,161,000 shares, each would be allocated $6.06. At that, what would a share of AVXL be valued at? How much of that $6 would drop down as a dividend?
Presently, about five bucks gets a share. In the future, might a share cost a bit more?
OOPS! It's them zeros.
Why yes, I'm off by a factor of a thousand, in the number of outstanding shares.
Disregard my posting. It's in error. I'll re-write it, correctly.
Thanks for spotting this. This will make the number more real, and accurate
--Falconer
One Set of Potential Anavex Income Metrics.
Because Anavex may soon gain authorization to sell blarcamesine as a recognized therapeutic drug, what might be the involved numbers? With recognized and inherently questionable suppositions, ponder these projections (which are offered for only the sake of curiosity; not in any form as investment advice).
First, let's select the number of patients that, in some time, will be taking blarcamesine. Let's take that total number to be 10 million patients each year, some time in the future.
Good enough. Very reasonable.
Now, big question. What will be the daily cost of blarcamesine therapy? I'll presume Anavex Life Sciences Corp will sell the drug for $2 for each day of treatment. For a year, that's $730, from each treated patient.
10 million patients each spending $730 each year on blarcamesine brings to Anavex Life Sciences Corp a total annual revenue stream of $7,300,000,000, $7.3 billion.
Presently, there are 60,191 AVXL shares in circulation. If that number holds into the future (likely will be higher), each share would represent $121,280.59 of the total annual corporate income.
Now, for those of us who hold an AVXL position, owning some of those shares, the big question is what fraction of that 121-thousand dollars ends up as an annual dividend? Each reader must decide.
Then, from that presumed dividend, extrapolate a likely AVXL share price. A good number of zeros to keep track off.
Those numbers too big? Ok, presume that only one million patients will take the drug worldwide. Then, to be really safe, presume Anavex charges just a dollar for a day's dosage. With those extreme low-end numbers, corporate revenues would be only 365 x 1 x 1,000,000 = $365 million in annual corporate revenues. Spread among the 60,161 shares, each would be allocated $6,064. At that, what would a share of AVXL be valued at? How much of that $6k would drop down as a dividend?
Presently, about five bucks gets a share. In the future, might a share cost a bit more?
I'll be in, bigger.
My spreadsheet calculations are similar.
I'm pretty competent in using the arithmetic functions of a spreadsheet to visualize all of the potential financial metrics of my rather moderate AVXL position. But, try running the numbers yourself.
To begin, there is only one rather solid number to start with, the number of outstanding AVXL shares. As I have it, it's 60,191,000. But for broader safety, I've presumed the eventual outstanding (in trade) shares total to be 100,000,000. Nice, safe number.
Then, in different cells, enter the number of people that will be treated with blarcamesine each year. I limited myself to just the US. Find a candidate disease and look it up on the internet. Enter the number of annual cases.
Now, in adjacent columns, enter potential sales prices per day of blarcamesine doses. From those, calculate annual Anavex revenues. I always presume a year to be just 300 days. The missing 65 days can account for various sales costs; taxes, etc.
With all of that, at any assigned daily drug cost, from $1 to $10 per day, there will lots of zeros in the corporate annual revenues columns.
Then, divide those annual revenues by the number of outstanding shares (100 million). That gives a revenues per share datum. For example, if 5 million Americans with Alzheimer's get treated with blarcamesine, at a dollar a day, that's 5,000,000 patients x $1/day x 300 functioning days in the year = $1,500,000,000; $1.5 billion of corporate revenues.
If there are 100 million outstanding shares, that's $1,500,000,000 of revenues / 100,000,000 shares = $15/share.
Of course, the price of blarcamesine, at least at the start, will probably be several dollars a day.
Then, Parkinson's disease. One source says about a million Americans have the disease.
Then, consider the entire Western world. Triple or quadruple the numbers.
Finally, for great fun, punch the numbers when it is determined that virtually everyone over age 50 needs to take an Anavex pill every day, to prevent the onset of a variety of geriatric disease; to maintain a degree of healthful youthfulness in the last third of life.
And, none of this considers the possibility of any of the Anavex drugs successfully treating or preventing other, non-CNS diseases.
I won't share my actual calculations. Too big to be believed. In reality, time and events will tell.
Yes, why the late-date inclusion of Anavex?
Then, Mr. Fox is contacted.
Better than the first announcement.
For sure, the release of the Parkinson's disease dementia(PDD) study at the big Alzheimer's conference is significant; will result in all sorts of new things.
Earlier, Dr. Missling's mention of "statistically significant" data in the PDD trial sealed the deal for me; before today's announcement. Missling has a PhD in science; knows what stat sig means and implies. He didn't arbitrarily speak of it. It was deliberate, real, as are, now, the therapeutic outcomes blarcamesine evokes.
But, today, having the PDD results revealed at a big Alzheimer's conference is even bigger. People who want to dismiss Anavex and blarcamesine, whether on this board, in doctor's lounges in hospitals, or over lunch tables in research labs, are, now, going to have a hard story to tell. The drug actually works, safely and effectively. The diehard naysayers can continue to lay out all of their objections, but, now, they are utterly irrelevant.
Can't beat actual clinical success. Detailed understanding of biochemistry involved in the MOA (mechanism of action) is no longer relevant. "Wait a minute. Is this 'blarcamesine' stuff safe? Can it really turn off or prevent dementia?" After the CTAD event, the Anavex case is closed. For CNS diseases, a new therapeutic era is about to start.
I doubt it. But...
In a few years, blarcamesine an Alzheimer's prophylactic.
A new study finds new ways of detecting early, asymptomatic Alzheimer's disease:
https://www.eurekalert.org/pub_releases/2020-10/wsu-rdm101920.php
In a few years, perhaps, middle-aged adults will have this test with their annual medical checkups. "Mrs. Smith, our tests show that you will develop Alzheimer's in the next few years. Fortunately, we can now slow or stop that from happening. Here's your prescription for blarcamesine. So glad we were able to catch this before Alzheimer's set in, and now have a drug that can slow or stop it's appearance."
Perhaps none.
Parkinson's Info at an Alzheimer's Conference?
So, Anavex is going to be releasing results of their clinical study of blarcamesine to treat Parkinson's disease dementia at, of all places, a major Alzheimer's conference. Does that make any sense? Parkinson's and Alzheimer's are two, distinctly different diseases. Ostensibly, this is a gross error. The results should be presented at a Parkinson's disease conference.
Of course, it's not a mistake. Anavex is taking advantage of the CTAD conference to present the Parkinson's results before a multitude of Alzheimer's experts and researchers, all of whom will quickly understand the presented data, and more importantly, grasp their applications for the treatment (or prophylaxis) of Alzheimer's.
Once and for all, this clever maneuver will validate and confirm the blarcamesine mechanism(s) of action, facilitating favorable activation of the sigma-1 receptor protein. The Alzheimer's people are going to see the quite favorable Parkinson's results, and then have to explain to various Alzheimer's stakeholders why they haven't taken this approach to Alzheimer's. "Wow, look at what that drug did for people with Parkinson's. And Anavex is testing it on people with Alzheimer's. No doubt, blarcamesine is now in the Alzheimer's game."
After the CTAD conference, everything discussed and written about blarcamesine will be different.
In a few years....
The prophylaxis factor.
Makes no sense to us, but....
Some unknown chemistry factor?
Better, because of tiny concentrations.
Attention will come.
Yet to be determined.
At near the low of the day.
Quite the opposite.
Eventual Headlines
The vast retail stock investor market (individuals) isn't going to know about or care about today's announcement until a report of it appears on the evening news or in major city newspapers.
What happens if an article in the New York Times or Washington Post has a headline, "New Drug Gives Hope for Parkinson's Disease?"
Then, a bit later, "New Drug Works for Rett Syndrome, Too."
Then, finally, sometime next year, "Long Trial Gives Solid Hope for Alzheimer's Patients."
Waiting now for three things.
The clinical trial results are positive, with validating statistical significance metrics. Now, a matter of time and events for useful impacts.
Just how (or if) the news and broadcast press announces today's news will be interesting. How will that news affect the public's perception of Anavex in general, and blarcamesine in particular? That's the first thing I'm waiting to learn about.
The other thing is how this gets discussed by family members with PDD. My brother in law has Parkinson's; but the dementia has not yet appeared. Very good chance blarcamesine, if taken soon, can slow or stop the appearance of that disease's dementia. I've already emailed my sister about today's news. She and her husband are in contact with others suffering from PD. How will the Parkinson's disease community receive today's news? Will Parkinson's stakeholders bring new pressures on the FDA, etc.?
But the real seal-the-deal info will be what appears at a Parkinson's disease conference, or appearing in a peer-reviewed journal, when the minute details of patient responses will be presented.
Nonetheless, Big Pharma Now Knows
For "them," not enough.
Anavex Science Is Real
Although more precise data of the Parkinson's disease dementia (PDD) study aren't yet available, the corporate announcement that blarcamesine demonstrated both safety and efficacy in a legitimate double-blind clinical trial now validates Anavex science. Until now, it had been demonstrated only in animal models of CNS (central nervous system) diseases. Now, in real humans, with a debilitating CNS disease.
Results are claimed to be statistically significant. Adverse events (side effects), if any, were inconsequential. Blarcamesine is safe at doses 30 to 50mg.
Inasmuch as there is no truly effective treatment of PDD, other than some antipsychotics, things are aligning for eventual FDA approval of blarcamesine. For that, three things must happen: 1. The new drug must have been proven safe in humans. That, now, has been done. 2. The new drug must have been proven effective in treating targeted disease symptoms. Now so proven. Lastly, 3, the new drug must match or exceed the efficacies of existing treatments. Accomplished.
Next will be similar results from the Rett syndrome trial. Then, finally, the results from the long-term Alzheimer's study.
The Anavex sigma-1 agonist mechanism(s) of action have been fruitfully demonstrated now in real humans, with statistical significance. Chance results and placebo effects are no longer in play. The Anavex science is real. The Anavex drug pipeline has no leaks.
Will be interesting to see how the general news press tells of this.
Watching, waiting.
Merely from vapid curiosity (and no press of time), I continue to read and ponder the plethora of messages appearing. I'm not seeing anything about Anavex science; only thoughts about the impacts or or implications of "missed" revelations of trial data.
"Real" AVXL share investors are welcome to those perspectives, pro or con. Surely, until some trial data appear, it'll be more of the same. For most, nothing else to talk about.
This is a start-up biotech, without a saleable product (no revenue stream). Even "worse," the science is new, and not much known or understood. Three on-going clinical trials in humans; but when they might actually conclude and reveal their results is unknown.
I am a biologist. I've conducted research projects myself; am a leading team member of a federally-funded research project right now. We had stated, believed, that we would present our findings in three years. But, nope. Won't happen. Will take two or three years longer than we claimed. COVID-19 intervened. And ours is a field-biology, ecology project. What are the chances that a viral pandemic that can impact all humans might complicate and slow the progression of a human clinical trial of a new drug?
I've pondered the probabilities of Anavex success at each of my several AVXL purchases. I've always targeted 2023 as my year of decision. If Anavex has gained approval to sell any of their drugs by then, I'll be grinning. If not, I will have lost my money and life will continue. Biotechs involve biology which can be vagrant, variable, and blurred. To presume that clinical results can be affixed to desired or even projected calendar dates is an error. It's not an error that fogs my vision on out into 2023.
Hopeful patience....
Speculation. At least as to share price.
'Dead money,' is it?
Barchart (https://www.barchart.com/stocks/quotes/AVXL/interactive-chart) plots the share prices of AVXL shares since they appeared, in January 2007, when it opened around $12.33. Shot to about $22 in February 2008. In February 2011 around $17.23.
Downhill from there to a low of about $0.33 in December of 2014. Let's see the 'returns' (paper numbers) for an AVXL purchase in January 2015 at $0.75. Today, AVXL closed at $4.46.
It's about 94 months from January 2015, to now, to October 2020; 7.83 years. In that period, an AVXL share has increased from $0.33 to $4.46, a 13.51x increase. That's an increase of 1351%.
I'll take that kind of "dead money" any day. If anyone can find another equity that will increase that much in 7.83 years, let me know of it. I'd be delighted to let my dollars be 'dead' for that time, with that final value.
Of course, what will AVXL be worth two years (not 7.83 yrs) after regulatory approval for sales and therapeutic usages for is gained for the ANAVEX drug? Let me punch this in.
Imagine that someone, today, bought $1000 of AVXL shares, at $4.46. Then, in seven years, in 2027, the share price value has increased 13.51x. That's a value of $13,510.00; at a share price of $4.46 x 13.51 = $60.25.
Anyone think that when Anavex is able to sell blarcamesine to tens of millions of people across the globe (in, say, five years) the share price will be around $60? Ha. Add at least another digit.
AVXL is "dead money," right? I'm glad to own a thousand 'dead' shares or so. They'll 'liven up' some day. For me, worth the wait.
They'll know.
Let me think...
Even better....
The Name. What will it be?
When approved for sale and therapeutic use, "blarcamesine" will not be the name on the pill bottle label from the pharmacy. Prescription drugs actually have three names. First is the actual chemical name. Blarcamesine, among chemists, is tetrahydro-N,N-dimethyl-2,2-diphenyl-3-furanemethanamine. Not too many will call it that.
Then (and now), the generic working name of the drug is blarcamesine. But when approved for sale, it will have another name assigned, the commercial product name.
For example, ever heard of anyone taking atorvastatin? How about clopidogrel? Oxycodone? Those are the generic working names of Lipitor, Plavix, and Oxycontin.
Some clever marketing people engaged by Anavex will come up with a new, final commercial name for blarcamesine. It will have just a few syllables; be easy to pronounce and remember.
In a few months after the name is assigned and the new drug is prescribed, it will be heard often in news reports; for all of the obvious reasons.
Of no consequence whatsoever.
Just a canoe.
Anavex, to the heart of a problem?
A very interesting new study (https://pubmed.ncbi.nlm.nih.gov/33010304/). Thanks for posting this.
In summary, treatment with a sigma-1 receptor agonist, fluvoxamine, produced favorable treatment outcomes in rats that had myocardial infarctions, heart attacks from decreased blood flow through the heart. For Anavex, this presents another, new disease target. Until now, most of those have been in the central nervous system. Now, the cardiovascular system — heart attacks. Are those a problem for anyone?
The sigma-1 receptor agonist in this rat study was fluvoxamine, an on-the-market selective serotonin re-uptake inhibitor, SSRI drug, used mostly as an antidepressant and anxiolytic, for depression. In comparison to the Anavex sigma-1 receptor agonists, fluvoxamine is not as active or strong. Don't you suppose Anavex right now is arranging for a replication of this study, but using blarcamesine or Anavex 3-71?
Another Anavex what-if. What if, indeed, chronic (continuous) dosing of either blarcamesine or Anavex 3-71 does in humans what it did in the rats? Might there be a market for such human therapies. How many Americans have myocardial infarctions (heart attacks) each year? How many might benefit from prophylactic (preventative, before it happens) dosings of an Anavex drug?
Cardiologists are eager to prophylactically prescribe any of the several statin drugs to those they think at risk of having a heart attack. Fine and dandy. But given the extremely tiny fraction of heart attacks actually prevented by statin dosings, if those are the SOC, standard of care, in regard to pharmaceutic prevention of heart attacks, what are the chances that the Anavex drugs could beat it?
Will an Anavex drug replace the statins? Pfizer, with it's Lipitor statin, took in $1.9 billion last year. https://www.statista.com/statistics/254341/pfizers-worldwide-viagra-revenues-since-2003/