Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I'm Not Impressed
Eventual Off-label Anavex Prescriptions for Anti-aging Prophylaxis
Again, the Anavex Prophylaxis Factor
External Drug Manufacturers Conduct No Anavex Trials
Quite Distressing
AVXL had its low of the day just after the market opened today, at $3.78. But, so distressingly, it didn’t appear that many buyers or sellers of the equity read or paid any attention to the smart people who posted all day here (and days and months previously) telling that Anavex is and will be a loser as a no-revenues, no products biotech start up.
So inexplicably, after the day-long straight line ascent AVXL closed at near the high of the day at $4.29. What was the all-knowing market thinking? A 12.3% share price gain for the day.
A European Drug Manufacturer
Read the company's website. They are a major European drug manufacturer. Their making of blarcamesine, with their new, patented processes fits perfectly with Anavex's desire to gain approval to sell the drug in Europe for Alzheimer's.
New, Patented Forms and Manufacture of Blarcamesine
The patent reads:
United States Patent Patent No.: US 12,018,005 B1
Szokol et al. Date of Patent: Jun. 25,2024
https://ppubs.uspto.gov/dirsearch-public/print/downloadPdf/12018005
The patent was granted to an Hungarian firm, which uses and acknowledges Anavex’s ownership, intellectual property rights to all forms of blarcamesine.
Here's the company that did the work:
https://int.egis.health/company-profile
The patent document makes these claims:
Thanks. Now have the 5 in the right column. The maximum acceptable p-value for statistical significance is 0.05, not 0.50.
The ADL Non-factor.
Blarcamesine Didn’t Fix Patients’ ADLs. Does It Matter?
Yes, the trial results from blarcamesine being tested in early-stage Alzheimer’s disease showed significant statistical significance for three of the four matters being assessed. Meaning, that for those three Alzheimer’s problems the drug provided significant therapeutic outcomes. For them, the drug works, safely.
But blarcamesine didn’t achieve, even closely, statistical significance on the “ADL” test. It had a reading of p=0.234. To be statistically significant, meaning that the result was authentically therapeutic, not some random-chance result, the p-value had to be p=0.05 or less. The blarcamesine against early-stage Alzheimer’s ADL factor failed miserably; way too high, nowhere near 0.5 or less.
Should this matter? Does blarcamesine’s ADL treatment failure indicate that the drug should not be approved as a treatment for early-stage Alzheimer’s? It’s important to consider what, in medical practice and research, “ADL” is: “activities of daily living.”
Consider them:
Blarcamesine Achieves Validity
In a recent posting I expressed my opinion that Anavex quietly had a lot important things happening and very positive developments should soon begin to be announced. The first of those just appeared, at the URL in the previous message.
On Sunday, July 28, 2024, that paper will be presented at the Alzheimer's Association International Conference in Philadelphia. This will validate both blarcamesine’s safety and efficacy in Alzheimer’s patients with early-stage Alzheimer’s disease.
The ability of blarcamesine to successfully treat four recognized Alzheimer’s disease severity metrics were assessed. The paper made this claim:
Big Things Developing, About to Happen
Well, the information presented, apparently from a person who physically attended the Anavex annual meeting, and took detailed notes, should be considered.
For the Anavex naysayers, who seem to put up the majority of postings on this message board, what can be read in this personal annual meeting report will be utterly and completely discounted. Just another deceived “we got this” bloke.
But, for those of us who have scrutinized all of the information on Anavex Life Sciences, especially in understanding the company’s unique and proprietary medical technology science, all of what the poster presented from the annual meeting makes sense.
In this regard.
Dr. Missling and his colleagues at Anavex Life Sciences Corp have a great number of on-going, soon to be revealed projects and developments that will transform the company, from a no-revenues biotech start-up to a major global pharmaceutical; whose drugs will transform 21st century medicine as well or better than did antibiotics in the last century.
We’ll all be watching. Some of us will be profiting.
The Anavex Autophagy Factor
A Key Anavex Process
No Change
At 10am, at the meeting opening, the AVXL share price was $2.70.
That's what it is right now. That's "sideways."
No Share Price Change
Doesn't look like anyone at the Anavex annual shareholders meeting ran out of the meeting place and made any big AVXL buys or sells. AVXL share price going sideways.
Check to see. The Anavex proposals are WAY out there.
Blarcamesine Will Come Out Way Ahead
To download the PDF, try this:
https://downloads.regulations.gov/FDA-2013-D-0077-0092/attachment_1.pdf
This downloaded the PDF for me, in my Downloads file.
The Anavex FDA Alzheimer’s Trails Proposals
It should be noted (read carefully) that Juan Carlos Lopez-Talavera, MD, PhD, Executive Vice President, Head of Research and Development, of Anavex Life Sciences Corp. has provided “additional comments on the FDA's revised draft guidance for developing drugs for the treatment of early Alzheimer's Disease (AD).“
Access the PDF here:
https://downloads.regulations.gov/FDA-2013-D-0077-0092/attach0ment_1.pdf
Dr. Lopez-Talavera has made six specific new proposals to the FDA on how drugs treating Alzheimer’s (such as his company’s blarcamesine) should be evaluated in clinical trials.
To be informed on the matter, read and consider the proposals. Understand, none of these would have been proposed without an understanding that they will facilitate the FDA’s approval of blarcamesine. Consider closely proposals 4, 5 and 6. Dr. Lopez-Talavera has information, understands that blarcamesine will favorably comply with these.
Because, as a biologist I understand....
Worth Waiting For?
For All, Great Blarcamesine Cost Advantage
Thanks for this posting.
Doubtless, once blarcamesine is approved for Alzheimer's, it will be far cheaper for both patients and insurance companies than any of the MAB drugs. It will become the Alzheimer's drug of choice, the SOC, the standard of care drug. First and foremost. No competition.
Could all of this be involved in the European drug approval agency's invitation to Anavex to submit drug approval data?
Put Up Your Numbers and Reasons
The questions of Anavex revenues, future share prices, etc., are commonly raised on this message board. The answers to these questions, with actual numbers and formation, are warmly invited; from all parties, pro and con. Take a few minutes and on a word processor page compose and edit a well-written posting. Then, copy it here so everyone can see your projected numbers, and the stated reasons they will be valid.
A lot more interesting and useful than generalized statements that "Anavex is gonna fail." Or, "With AVXL you'll be a millionaire."
More Wrongness.
Understand, All of the Following Is SO Wrong
I've Learned From the Expert
Still, I'll Sleep Well
But, in, say, three years?
A Future Donation
But some here are experts.
More Drug Development Processionals Destined to Failure
Rewarding Margins on Both Sides
Will Reconsiderations of Blarcamesine and Anavex Appear?
Anavex made this announcement:
Anavex Researchers Are At Work
Anavex Unknowns
An Analgesic Future for Anavex Life Sciences Corp?
Now, with the patent-protected potential of AV1066 being able to treat nociceptive and neuropathic pain, as with the other Anavex molecules entering human trials for other diseases and conditions, when they happen, we will watch closely the results of clinical trials of this new drug.
If the drug proves safe and effective in humans, would there be much of a market for it? How many suffer from "nociceptive and neuropathic pain?" Might AV1066 be free of the many obviating side effects of conventional pain drugs? How will it compare, say, to morphine?
So that all of the usuals won't have to, I'll diligently suggest that no one should buy a single AVXL share in speculative anticipation of Anavex revenues from this new analgesic. It may not prove effective or safe; may never be approved for sale or therapy. We'll have to wait and see.
But, if it proves to work in humans? Well, run your own numbers. A lota people have nociceptive and neuropathic pains.
Anavex 3-71 Treatment Periods Need to be Determined
The Outlook for Anavex 3-71 and Schizophrenia
Anavex’s initiation of early-stage proof trials of Anavex 3-71 for the treatment of schizophrenia needs to be seriously considered. What if these early trials show that the drug does show treatment efficacy, absent obviating adverse events (serious side effects)? A number of additional factors will then come into play, and must be weighed.
First, the size of the schizophrenia market for a safe, effective, relatively inexpensive drug that can be administered orally. For accuracy, do your own look-up on this market. It’s gigantic; a major unmet medical need.
Next, consider the difficulties in manufacturing, selling, and properly administering Anavex 3-71 for schizophrenia. There are none.
Anavex 3-71 is a small molecule, for which Anavex has demonstrated synthesis processes. The drug can be efficiently and inexpensively manufactured.
Then, unlike many drugs treating CNS diseases, for schizophrenia it will be administered per os, by simply swallowing a pill. No injections. No need for patients to go to medical facilities for intravenous, IV, procedures.
Therefore, the drug can be sold as conveniently as any pill-form prescription drug.
Run your own numbers. How many patients will be taking Anavex 3-71 for schizophrenia? Try running a range of patient purchase prices for the drug. Then, extrapolate those metrics to anticipated annual Anavex 3-71 revenues coming in to Anavex Life Sciences Corp.
Then, with the ranges of numbers you determined, ponder if some Big Pharma might be interested in acquiring the sales rights to Anavex 3-71 for schizophrenia. How much might they want to offer Anavex for the drug?
Or, if Anavex chooses to keep everything in-house, eventually, after a few years, after the company has developed (or contracted for) manufacturing and sales rights, what would be the range of annual 3-71 revenues to Anavex Life Sciences Corp.
Finally, as an AVXL shareholder, I’d like some reasonable estimate of the annual dividend dropdown (payout) from the 3-71 revenues.
For myself, on my own spreadsheet, I’ve punched all of these metrics (and their ranges). Should the Anavex 3-71 schizophrenia clinical trials prove successful by the end of summer or this year, my small AVXL holding will make the beneficiaries of my estate, my spouse, children, and designated philanthropies, well rewarded.
Simply, the Anavex 3-71/schizophrenia connection, alone, has the potential of making Anavex Life Science Corp a very profitable enterprise.
But, how come no warnings, here, for shorters?