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Australian Availability of Blarcamesine Now Assured
HL Pharma is pleased to announce we are working with Anavex Life Sciences Corporation to facilitate the ongoing supply of medication to patients post clinical trial completions for Rett Syndrome and the treatment of Alzheimer’s Disease.
At low of the day.
Very pleased. I picked up a few more shares of AVXL at the low of the day today. Had a few discretionary dollars available in my budget.
In 2023 I'll be making my final decisions about this and my previous Anavex share purchases. I regard this as a small investment, not a speculation.
Today, small in regard to the total number of shares I've accumulated. But by 2023, when Anavex is likely to be treating a number of CNS and other diseases with proprietary, authorized drugs (blarcamesine and Anavex 3-72, perhaps others by then), the value of my Anavex equity position will not be so small.
Parkinson's Research
A new report on some Parkinson's disease research includes these statements, which are related to Anavex:
...a disease that is the fastest growing neurological condition in the world, with no cure currently available. ... They discovered a series of misfolded protein structures that have never been observed before.
Could this really be?
Out of the hundreds of people involved in a trial, family members, caregivers, hospital workers etc, the word leaks out, and I’m sure it gets back to the company.
Example- a clinic worker overheard two family members leaving the clinic saying “ OMG Karen, I can’t believe the change that we have seen in Frank over the last few weeks, he has really made a huge improvement!”
Thank you.
Very much appreciate your technique and the content of your text.
Unique, favorable molecular architectures.
And the phenomenal biochemistry comes from?
Decidedly, Anavex is different, better.
Thanks for posting this. I read the article in a quick first-read. It was published a year ago, but refers, in the case of Anavex, to clinical trials then still in early progress.
The general perspective of the author was that there are, indeed, a number of drugs that bind to the sigma-1 receptor protein, and they may eventually show some level of efficacy against various CNS diseases. At this point, accurate.
But what the author fails to understand, or elects not to state, is that the sigma-1 receptor agonists of Anavex Live Sciences Corp, primarily Anavex 2-73 (blarcamesine) and Anavex 3-71, are not equivalent to the several other agonists he mentioned (fluvoxamine, donepezil, haloperidol, and pentazocine). In fact, no comparison.
Yes, a number of molecules can bind to the sigma-1 receptor protein, and to some degree activate it, allowing it to more formidably modulate a multitude of cellular processes. But, simply, the Anavex molecules do this far more strongly and effectively.
First, the drugs have to get into the cells to work. Cells have a variety of ways of keeping most molecules and ions out. The Anavex molecules are small, and have chemistries that allow them to diffuse into neurons. Not a simple task. One of the reasons the other sigma-1 receptor agonists are not as effective may be because few can gain entry into target cells .
Not a problem with the Anavex molecules. Importantly, blarcamesine is administered peroral, by mouth. Not by an injection that by-passes the gastrointestinal system to get adequate concentration into the blood stream. That happens sufficiently by merely getting the drug into the stomach, where it is not lost or digested. It diffuses into the blood stream, then into cells throughout the body.
This will be particularly true with Anavex 3-71, as preclinical murine tests have shown that dosages are measured in micrograms, not the milligrams with blarcamesine. That's a factor of a thousand less. One-thousand micrograms in a single milligram.
Therefore, Anavex 3-71 has at least two things going for it. It is apparently much better at diffusing into cells. Dosages are much, much lower. Then, at those tiny doses, profound therapeutic outcomes are induced. Lastly, because of the tiny doses, chances for side effects are minimized, if not altogether obviated.
So, no comparison between the Anavex sigma-1 receptor agonists, compared to the others mentioned in the article. Big, powerful Anavex apples, compared to shrinking, moldy oranges.
When clinical results appear from any of the three Anavex trials, it will no longer be accurate or appropriate to lump all sigma-1 receptor agonists together. Clearly, the Anavex molecules will be revealed as a separate, exemplary category — to begin to successfully treat CNS and other diseases.
No, just unique, phenomenal biochemistry.
As far as I know...it would truly be a miracle!
My sincere thanks.
Just wanted to say sorry Bout your Dad Falcon.
There is a higher-up to consider.
Is our FDA going to be so pompous as to not have high level discussions about 2-73?
No, just in Australia.
I doubt that this thoroughly back door route to Australian approval would move the FDA to approve 2-73 for AD without a blinded, placebo-controlled trial.
From a TGA insider:
...around 75% drugs eventually get approved after SAS, unless there are safety concerns while under SAS.
And many have severe, debilitating sleep problems.
...half the population of those nursing homes suffer from dementia.
Datum. A single quantity or number. Data, the plural; many quantities or numbers.
Properly and accurately, I used a single datum for each entry, such as the presumed number of Alzheimer's patients in the US in some given year. That number is a datum. A collection of numbers are data, plural.
One datum, many data.
On a spreadsheet, punch the numbers.
On my spreadsheet, I've entered all of the various data, to see the probable ranges of Anavex annual revenues, possible percentages of those that might drop down and be distributed as dividends, and probable share prices. I've done this for several of the targeted central nervous system (CNS) diseases for which blarcamesine might be therapeutic.
At every try-it-and-see entered datum, stunning results. Not hard to understand. The first two diseases, Parkinson's disease dementia, and Alzheimer's disease, collectively, afflict millions across the globe each year.
Stunning calculations, from the lowest to the highest starting figures (number of patients, revenues/patient/yr). But, no, I won't post any of those data. Those who have no competency with the elemental arithmetic of spreadsheets would question the accuracy or applicability of my calculations. Or, my baseline data would be questioned. "No, there aren't that many people in the US who really have Alzheimer's."
If you are unable to use a simple spreadsheet, connecting arithmetic calculations in each cell; or, unable to determine reliable CNS disease numbers in various populations, like everyone else you will have to just guess the numbers; thinking that guestimates derived from the abundance of postings on this message board will provide sufficiently accurate numbers.
Good luck.
One set of calculations I haven't punched in yet are my average annualized share value gains over the many years I've owned my AVXL position. My average base price is a good bit lower than the current share price range. I have a paper profit. But over the years, it's been a rather small gain for my holding. Had I invested those dollars in a general exchange-traded-fund (ETF) or mutual fund, I'd almost surely have a more valued investment position.
But, as I've mentioned previously, from the start I've targeted 2023 as the year to determine the relative value of my AVXL investment. By then, I have every reason to believe I'll have been rewarded with rather large share price gains — better than anything I could have gained in a mutual fund or ETF.
But my spreadsheet cells look into the many years after 2023. Then? Well, even with my rather moderate AVXL position I and my family will be "financially comfortable," dare I say
But far better than that, millions of people will no longer suffer from trying to live with Alzheimer's and some other CNS diseases. I should be one of those. Eventually, blarcamesine will be available for off-label prescription. I will take it to treat the spasticity of my legs, resulting from a gamma-aminobutyric acid (GABA) deficiency in the long motor neurons that connect to muscles in my legs; a trait of the hereditary spastic paraplegia (HSP) which I have.
But the "market" can't understand the MOA.
The market is speaking loud and clear to those who care to listen.
A rat?
falconer, I'm calling Anavex HQ tomorrow and volunteering for any trial it conducts on CV-19.
My error.
Thanks for the cogent posts. I was wrong. Anavex has very publicly described how their molecules might work against COVID-19.
But I doubt they will be mentioning any of their test results on murines with COVID-19, being treated with any of the Anavex molecules just yet.
I'd be delighted to see a journal article telling the details of an Anavex-sponsored research project on their molecules against murine COVID-19. If positive, that would change the game altogether. Hope it can happen.
Silence.
Anyone ask IR if they are working on covid19?
Then, Anavex 3-71....
Anavex 2-73 (blarcamesine) is a rather simple molecule. It won't be expensive to have synthesized by some chemical production contractor. Lots can be made, inexpensively.
But all of the murine data I've seen, in tests in rats and mice with human diseases, after eventual human tests, indicate there is a very high probability that Anavex's other main sigma-1 receptor agonist molecule, Anavex 3-71 will replace blarcamesine.
In fact, Anavex 3-71 is far more active (1000x) than blarcamesine. Blarcamesine dosages are measured in milligrams (thousandths of a gram). Anavex 3-71, however, is active and efficacious in microgram dosages; millionths of a gram.
Actual production costs for dosages of Anavex 3-71 may be in the pennies.
Also, in microgram dosages, commensurately reduced chances of adverse events, side effects.
Drug advertising in Australia.
Here are the laws and regulations governing the advertising of "therapeutic goods" (including medicines) in Australia:
https://www.legislation.gov.au/Details/F2019C00618
First, none of that applies to or restricts advertisements directed solely to health professionals, such as mailed or digitally-distributed info to professionals:
(2) This instrument does not apply to an advertisement that:
(a) is directed exclusively to health professionals; or
(b) is part of, or otherwise comprises, a public health campaign.
But after spending a few minutes in a cursory read-down of the regulations, it appeared that Anavex could, indeed, (should they decide to) run ads for blarcamesine. It appears they would have to tell the SAS requirements. But I discovered no prohibitions of advertising associated with the SAS regulations.
To create a market. No advertising costs.
Why would Anavex want to sell an unapproved drug at low prices or even at a loss?
PA-Lite?
Should we consider the Australian Therapeutic Goods Administration's new Special Access Scheme (SAS) approval for the confined prescription and use of blarcamesine as a reduced or fractional Provisional Approval (PA)?
Does Anavex now have a PA-Lite for blarcamesine in Australia?
More importantly, was this done by the TGA to slowly, incrementally ease into an eventual PA, allowing Anavex time to ramp up production and arrange for pharmacy availability? (Do Aussies follow the British terminology? Pharmacists are "Chemists?")
Will the sequence be: first, PA-Lite, then PA, then finally, full approval; all done in a slowed sequence that allows for full product production and sales? No complications of inaccessibility or unavailability.
Pretty smart, them TGA poohbahs.
Anavex and Microsoft
In the mid 1980s PCs (personal computers) became affordable and useful. I started doing my biology teaching work on (remember them?) a PC Junior. Compared to today's desktop computers, so slow, so lacking in features. With a rudimentary word processor and spreadsheet, I could construct tests, teaching materials, and record grades. As rudimentary as the technology was, it was nevertheless a great improvement over typewriters, pens, and on-paper records.
I taught advanced placement biology in a local high school. My classes had a number of really smart, computer-competent students; who so very helpfully guided my implementation of the then rudimentary computer technology into the preparation of course materials, etc.
I distinctly recall that one spring, in 1986, just a few weeks after Microsoft offered their IPO (initial public offering) for the sale of new stock in their company, one of my computer-competent students said that I should spend just a few hundred dollars with a new MSFT (Microsoft) equity position.
I thanked him, saying, "Well, thanks. Keep me posted how this company develops." He did. A few years later he was getting his PhD in advanced electrical engineering. By then share prices of MSFT were way above the price in the high $20's in 1986. Every time I looked, the MSFT share price had continued to climb. I would wait for a big fall-back, and get in at some "more reasonable" share price. Sure. Reasonableness never appeared. I never reaped any rewards from an early position in Microsoft.
Might Anavex turn into a pharmaceutical Microsoft? Microsoft achieved its success because it had products and services no one else had, and for which a multitude of buyers have continued to want. Could the new drugs owned by Anavex eventually, in many years, make the company a multi-billion dollar entity? Knowing the company's science, I believe this, ever slowly, will be the case.
But it won't happen in the near term. The company is not likely to be profitable until 2023 or 2024. Anavex won't have revenues in the billions until some time later in the decade. I understand that. For me, two considerations, regarding my moderate AVXL holding.
First, Anavex may not succeed, for any number of yet unknown reasons. Therefore, I've invested only money on Anavex that if lost will not in any way affect my larger personal finances. From the start, with my first AVXL purchase in 2016, I recognized it would be many years before the company would be successful. More recently, I've targeted 2023 as my sellout-or-hold year. If matters progress as I anticipate, I'll be holding my AVXL position for many years following; probably adding to it as new discretionary funds appear.
That's the second point. I haven't bet my ranch on the company. My lifestyle will be unaffected if the company fails. But just the opposite if it succeeds, as anticipated.
I mention all of this because the vast majority of posts here deal ever so ominously with daily or short-term AVXL share price trends. At this moment, it's up 6 cents "rebounding" from a larger several-day price slide. For me, no big price deal; up, down, or sideways. Like a number of other Anavex investors, my time perspectives are years out. Short-termers are welcome to present their perspectives, which for me sometimes are entertaining reads. But I'm looking out to 2023. I have an investment, not a daily share-price play. Different styles. We long-termers just sit back and watch. (And have noted that not a single event or clinical finding has appeared that could stop the progression of corporate successes. The science it both valid and good; and, I believe, will prevail by 2023.)
Best wishes to all who follow Anavex Life Sciences Corp. Very likely, Anavex will become a pharmaceutical Microsoft.
Lab rats with autism?
I'm assuming that Anavex is filing this new patent (for treating autism) based on successful studies using murine animals, correct?
How big will Anavex get?
AVXL gaining momentum in the CNS space. What will it take to get a competitive market cap to other bios?
A new Anavex disease target, autism.
Particular
reference is made to the treatment of autism spectrum disorder,....
Let's watch for new production.
Meaning all of the more than 342,000 Australians with Alzheimer disease can at some point be eligible for treatment with 2-73 after a, quote... "physicians request".
But, can Clint be believed?
Just talked to clint, yes it is approved for all AD patients in Australia.
Will this be in the general press?
We shall watch with interest to see just how or what parts of this new Anavex story get reported in the general press.
Option One. Nothing appears anywhere; neither in investment rags nor in newspapers or magazines. Story not regarded as worthy.
Option Two. Brief, short paragraphs merely repeating a few sentences of the Anavex announcement. Few would see or consider it. A matter of no presented consequence.
Option Three. A moderately detailed story touching upon the drug's new but restricted availability in Australia. No mention of the implications of the drug's availability, neither locally in Australia, or eventually across the globe. Readers would have a moderate interest in the article; but otherwise of no consequence.
Option Four. A many-paragraphs article tells not only that the drug will now be available in Australia, but that it portends or presages eventual availability across the globe, and with that Alzheimer's will finally be a treatable disease. When that becomes the public's perception, everything for Anavex Life Sciences Corp (and its shareholders) changes forever.
Tomorrow, let's see what starts to appear.
I'd be in.
Maybe we can also get 2-73 to be used here in the US under Right To Try....
Did Anavex, or TGA determine the date?
Some are claiming that Anavex decided to announce this today, putatively to offset negative information tomorrow.
Really? Do they control the Australian Therapeutic Goods Administration, controlling and directing when they announce their regulatory decisions down there?
Sure.
How will FDA regulators respond, if at all?
Ok, then, what happens when in a few weeks dozens of Australian doctors request permission from the TGA to prescribe blarcamesine for hundreds of their CNS patients? Think that might appear in the Australian press? Suppose reporters might start following the patients, reporting their blarcamesine-induced outcomes?
Then, what happens if in a month or two there are copious reports of, say, Alzheimer's patients who can now sleep well? What will their spouses be telling the news reporters? What sort of stories will they be writing? Might the reading of them cause lots of other patients to petition their physicians for "that new Anavex drug?"
With all of that, would Americans with Alzheimer's be asking their congressional representatives, "Hey, why can't we get this here?" Can you envision the FDA head squirming in his chair before a hearing of a congressional health affairs committee? Imagine the conversation.
What could the TGA be thinking?
More than the revenue, it is the fact that a government body has recognized that this drug can be prescribed post trial. This is a validation of the efficacy and safety of the drug.
Well, they breed like mice.
Don't you think the supply of these mice is incredibly limited compared to demand?
Another new mouse strain for COVID-19 drugs.
The Yale University School of Medicine has now developed a new mouse that gets COVID-19 disease; can be used for testing new COVID-19 drugs (such as Anavex 2-73, or Anavex 3-71):
"The [new mouse] model provides a vital platform for testing prophylactic and therapeutic strategies to combat COVID-19."
This is the second such mouse strain to be developed, and available to Anavex to test their sigma-1 receptor agonists as prophylactics (preventions) or therapies for the COVID-19 disease itself.
https://www.eurekalert.org/pub_releases/2020-08/rup-rdn080420.php
Thanks; but yes, I don't know much TA.
With my open $3.80 bid I'm playing with not much money; more for fun, to get the even, rounded off accumulated share total. (Can do that sort of thing, now that Schwab doesn't charge for trades anymore.)
I'll watch the prices closely tomorrow; will probably then make a purchase somewhere. Thanks for your perspectives. Were I a trader, I'd be much more studious of all that you present.
After my small acquisition, I'll be back entirely to Anavex fundamentals.
Ok, Got My Cheap Bid In....
...maybe 3.80...then a turnaround rally.
Very likely, very positive.
...what do you think the chances are for all three disease trials to go in one direction versus trials going in separate directions?
Will Be Rounding Up My AVXL Position
By buying a moderate number of AVXL shares, I can round up my position to nice, new, larger four-digit number. Will make it easier to quickly calculate potential, eventual AVXL account values (hee, hee). Always easier to do in-the-head calculations with lots of zeros and only a single integer. Works well with my eighth-grade math capabilities.
So, I'll be closely watching the AVXL share price this week; intend to acquire my new shares by close of business on Friday.
Will there be a corporate announcement before the market opens on Monday (tomorrow)? If so, I'll have to weigh closely what it says and guess how it will affect the share price, first at the open on Monday (tomorrow), or later in the week. Do I jump right in and ride the ascent? Or, wait and see if the share price drops later in the week?
Then, of course, there may be no announcement tomorrow morning; another week for the AVXL share price like all the others this summer. If so, I'll put in a way-low, good-til-cancelled bid and see if I can pick up my new shares at the lowest price.
Of course, these are discretionary dollars in my household budget. Haven't yet, and won't now bet the ranch on AVXL, even though as a biologist who understands the unique biochemistry and cellular physiology of the activated sigma-1 receptors, I believe the company (and its shareholders) are destined for great things. If none of the clinical trials turn out well, I'm not financially harmed. If any one of them is positive (the far greater likelihood), I will be nicely rewarded.
I'm making this share purchase as an investment, not a trading position. I've always had 2023 as my target, decision year. Don't intend to sell a share until at least then. If things develop as I expect, I probably will sell no shares. They will, in time, yield some dividends, but will be passed on to my children with my estate.