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Alzheimer’s Article in Today’s Science
As a biologist and member of the American Association for the Advancement of Science (AAAS) I receive and read each week’s edition of Science, a major science journal. Today’s edition had an article titled “At last, modest headway against Alzheimer’s.”
Of course, all of us await the publication of the promised journal article that will validate blarcamesine’s clinical efficacy in the treatment of Alzheimer’s disease. Each issue of Science has a number of important science research articles, all peer-reviewed, but very unlikely the Anavex paper will appear in Science. Most likely, it will appear in a journal dealing specifically with medical research.
Still, I was interested to learn what Science was posting about “headway against Alzheimer’s.” Inasmuch as Science is the premier American science journal, its readership includes science policymakers at all levels. Anything in the article related to Anavex and it’s molecules?
Nothing specific. The article focused only on the “headway” being made with two monoclonal antibody drugs, noted in this excerpt:
Past, or Present? Prophetic, or Real?
Ok, which, then. was it in the patent? First, the patent rules state:
Closed at High of the Day
Haven't seen this happen for some time. AVXL closed at the high of the day, at $8.45, with a 7.10% gain for the day. Any reasons?
Did someone try to read the new Alzheimer's paper but thought it was a report on Anavex's clinical trial; after the first few sentences of the abstract could be read on the pay-walled snippet? If so, what happens when the real peer-reviewed journal report gets released, showing stat-sig positive clinical results?
What? Board Members Don't Know?
"Blarcamesine turns into the homestretch, pulling away...."
A Message Board, of Diverse Perspectives
The End is Coming ... Maybe
Thanks; But Sarcasm was Fractional
We Can Understand. So Sadly Frustrating.
New Anavex Executive's Education
According to the info on the LinkedIn webage, Dr. Edwards’s degrees were these:
Ph.D., Toxicology
University of Kentucky
1997 - 2004
Bachelor of Science (B.S.), Chemistry
James Madison University
1991 - 1994
What Could This Guy Be Thinking (or Know)?
So, after several others recently, another experienced drug science professional, one Dr. Jeffrey Edwards, signs on with Anavex Life Sciences Corp, as Vice President of Clinical Pharmacology. From LinkedIn, here are Dr. Edward’s previous drug company positions:
Vice President of Clinical ScienceVice President of Clinical Science
Acer Therapeutics Inc.
Vice President of Clinical Science
Madrigal Pharmaceuticals
Executive Director of Clinical and Preclinical Pharmacology
Intercept Pharmaceuticals
Director of Clinical Pharmacology and DMPK
Intercept Pharmaceuticals
Principal Investigator
Amylin Pharmaceuticals
Associate Director, Senior Scientist, Scientist II, Scientist
Arena Pharmaceuticals
https://www.linkedin.com/in/jeffrey-edwards-07b0844a/details/experience/
Before Dr. Edwards signed on with Anavex, any chance that he first demanded to scrutinize all of the data Anavex has relevant to the potential approval of their candidate drugs? If those clinical results data are as bad as the Anavex naysayers tell us on this message board, why would he then decide to sign on to a sure-to-fail start-up biotech?
Who’ya gonna believe?
Not merely lifesaving therapy; quality of life preservation.
“Imagination” will fail. Knowledge will succeed.
Ok, 2.4% Instead of 5%
Yes, a 5% Dividend Dropdown is Very Conservative
Eventual AVXL Share Price and Dividends Estimation
At 11:48am today the AVXL share price hit $8.18; an 8.06% gain for the day. What’s driving this steep share price ascent? “The market” or “the street” seem to be taking on new perspectives concerning Anavex Life Sciences Corp.
Here’s something that people with both potential and existing AVXL positions, just for fun (presently) should try. I just did it, and in every one of my iterations the final numbers were, well, phenomenal.
What are the potential values related to the holding of AVXL equities? What might future dividends and share values be? More importantly, what could be the actual ranges for these metrics? Here’s how I determined those.
On a spreadsheet, or with a calculator and a sheet of paper, try setting down various values. Here’s the ones I plugged in (but I won’t give the numbers I assigned to each –- that’s something for each AVXL investor to do).
In cell 1A, enter “Number of Barcamesine Patients.” In cell 2A, write in the number of patients you think will be treated in a given year.
In cell 2A, enter “Daily Drug Cost.” In cell 2B, enter the dollar amount you estimate a day’s treatment with blarcamesine will cost.
In cell 3A, enter “Annual ANAVEX Revenues.” In cell 3B, enter the formula =b1*365
In cell 4A, enter “Dividend Dropdown %.” In cell 4B enter the percent of annual revenues that you estimate will go out as dividends. If you think 5% of annual revs will go out as dividends, enter “0.05.”
In cell 5A, enter “Total Dividends Distributed.” In cell 5B, enter the formula “=b3*b4.”
In cell 6A, enter “No. of AVXL Shares.” In cell 6B, enter the number of AVXL shares in circulation. In my calculations, I used “100,000,000.” Presently, there are 81,950,000 AVXL shares.
In cell 7A, enter “Annual Per-share Dividend.” In cell 7B, enter the formula “=b5/b6.”
In cell 8A, enter “Owned Shares.” In cell 8B, enter the number of AVXL shares you own or will purchase.
In cell 9A, enter “My Annual Dividends.” In cell 9B, enter the formula “=b7*b8.”
In cell 10A, enter “Estimated P:E Ratio.” In cell 10B, enter a number you think is the price to earnings ratio number. A “20" will indicate that that the share price will be 20x the dividend.
Finally, in cell 11A, enter “Value of My AVXL Holding.” In cell 11B, enter the formula “=10b*8b.”
***********
Personally, I’ve accumulated over the years several thousand AVXL shares, presently with an 83% value gain. If Anavex is able to treat only a few hundred thousand patients a year, with very moderate $1000/year drug costs to the patient or insurance company, I and my beneficiaries are going to be very comfortable.
Are you considering the taking of an AVXL equity position? Plug in these numbers and see what a $500 dollar purchase of AVXLs might be worth in five years, when blarcamesine will actually be treating millions of people with CNS and other diseases.
Blarcamesine Prophylaxis Won't Be "Proven" But Discovered
And, eventual prophylaxis.
Now it’s getting to be something of a pattern.
Another PhD with extensive drug company experience bales from his position with an operating pharmaceutical and elects to sign on with a small biotech startup that has no manufacturing facilities, no sales force, and no revenues because the company has no approved drugs.
Like all of the other new, recent drug-expert employees hitching their careers to the Anavex train — which is still at idle in the station — what could this Dr. Jeffrey Edwards, Vice President of Clinical Pharmacology and Science at Anavex Life Sciences, know or believe about his new employer? Might he have some information none of us have learned yet?
Wait! The Real Reason Dr. Kellerman Signed On.
Another Drug Development Specialist Signs On
Terrie Burrell Kellmeyer, PhD
Senior Vice President Clinical Development at Anavex Life Sciences
So, another drug-science professional signs on with Anavex. What could she be thinking?
Employment history info here:
https://www.linkedin.com/in/terrie-burrell-kellmeyer-phd-77657613/
Here’s what her former employer, Acer Therapeutics, told about her qualifications:
Anavex Surely Has Aging Data Already
What If An Anavex Drug Gets Widely Used?
First, stop reading if you are looking here for useful investment advice. That’s not the intention whatsoever of this off-the-charts posting. Merely for curious contemplation....
What happens if, in, say, five or ten years, it is discovered that the homeostatic restoration properties of either blarcamesine or Anavex 3-71 markedly and safely slow normal aging processes in neurons and other cells or tissues; that those taking an Anavex drug safely gain prolonged good health after the age of 40 or 50?
As a result, either of the Anavex drugs can be taken as can aspirin, and those taking a daily Anavex drug have long, disease-free lives. Application of the Anavex anti-aging prophylaxis factor.
Let’s next presume that a daily dose costs the individual taking it a mere $1.00 each day. Not at all unreasonable. The drugs are small, not overly complicated molecules; of inexpensive manufacture. Anavex holds patents on their efficient manufacturing processes.
Next, in my spreadsheet calculations, I’ve presumed that, eventually, 500 million people across the globe will be taking an Anavex drug each day of each year. At a buck a day, that would be $182,500,000,000 in annual revenues going to Anavex Life Sciences Corp.
I next presumed that there would be a 5% dividend dropdown; that for each dollar of revenue Anavex would distribute $0.05 as a dividend out to each AVXL share in circulation. That calculates that Anavex would distribute as dividends a total of $9,125,000,000 each year.
I then presumed by that time there will be 100,000,000 AVXL shares in circulation.
With those metrics, the annual per-share dividend would be $91.25. I have a small holding of several thousand AVXL shares. Should all of this play out as described, this will be for my family and beneficiaries generational wealth. But even if I’m off by two orders of magnitude (100x too high), I’ll still be quite comfortable.
Now, back to today’s reality. For the above, I’ll check back in five to ten years.
The Real Story Will Be In the NYT.
Who’ya gonna believe?
No One Reads or Believes Other Journals?
Very Frequent Publication; Weekly
The Journal Article Will Be Definitive
In A Year, No More Controversies
A New Clinical Trial for Blarcamesine?
Blarcamesine First as an Insomnia Treatment?
Could it be that Anavex is now pressing for blarcamesine as a treatment solely for the agitation and insomnia of Alzheimer’s, instead of a treatment for the cognition pathologies of that disease? Might that approach be an easier route to commercialization of the drug?
The vast majority of those suffering with Alzheimer’s have agitation or sleep difficulties consequent to the onset of this CNS disease. The market is gigantic. And, of course, those being able to take blarcamesine each day or two for their Alzheimer’s agitation or insomnia will incidentally also experience improved cognition. Two symptoms are targeted, agitation and insomnia, but a third symptom, cognitive decline, is incidentally reversed. Three for the price of two.
Read the Examples in the Patent
Below are the examples cited in the patent. Read and assess the improved sleep in each case:
Example 1
Maintenance Insomnia Therapy
(49) A 48 year old female presents as suffering from maintenance insomnia for one year. She is started on oral A2-73 at 10 mg/day. Follow up at 30 days of daily dosing reveals she is sleeping well. She is currently maintained on 10 mg of A2-73 and is sleeping well.
Example 2
Anxiety Therapy
(50) A 51 year old female presents with anxiety of three years' duration. She is administered A2-73 at 20 mg oral per day every other day. Resolution of the anxiety is noted after two days of dosing. She is maintained on this dosing schedule for 60 days.
Example 3
Agitation Therapy
(51) The patient is a 29-year-old male exhibiting agitation. He is treated with 30 mg A2-73 oral daily for 30 days. Clinical evaluation reveals normal affect without agitation, depression, anxiety, or substance use. He is currently maintained at that dosage and is not anxious.
Example 4
Maintenance Insomnia Therapy
(52) A 68 year old female presents with MCI and reports maintenance insomnia for one year. She is started on oral A1-41 at 10 mg/day. Follow up at 30 days of daily dosing reveals she is sleeping well. She is currently maintained on 10 mg of A1-41 and is sleeping well.
Example 5
Anxiety Therapy
(53) The patient is a 52 year old female with diagnosed AD and reported anxiety of three years' duration. She is administered A19-144 at 20 mg oral per day every day for 90 days. Resolution of the anxiety is noted after two days of dosing. She is chronically maintained on this dosing schedule.
Example 6
Maintenance Insomnia Therapy in MIC
(54) A 66 year old male diagnosed with mild cognitive impairment presents as suffering from maintenance insomnia for one year. He is started on oral A2-73 at 50 mg/day. Follow up at 30 days of daily dosing reveals he is sleeping well. He is currently maintained on 50 mg of A2-73 daily and is sleeping well.
Example 7
Maintenance Insomnia Therapy in Alzheimer's Disease Related Insomnia and Agitation
(55) A 72 year old male diagnosed with Alzheimer's disease presents with insomnia/WASO and agitation and a systolic blood pressure of 145 mm Hg. He is started on oral A2-73 at 30 mg/day. Follow up at 30 days of daily dosing reveals he is sleeping well through the night and not waking up repeatedly and his systolic BP is 129. He is also less agitated. His results on all cognitive tests and HAM-D improve. He is currently maintained on 30 mg of A2-73 daily.
Example 8
Maintenance Insomnia Therapy in Alzheimer's Disease Related Insomnia and Agitation
(56) A 72 year old male diagnosed with Alzheimer's disease presents with insomnia/WASO and agitation. He is started on oral A2-73 at 100 mg/day. Follow up at 30 days of daily dosing reveals he is sleeping well through the night and not waking up repeatedly. He is also less agitated. His results on all cognitive tests and HAM-D improve. He is currently maintained on 100 mg of A2-73 every other day.
Example 9
Maintenance Insomnia Therapy in Alzheimer's Disease Related Insomnia and Agitation
(57) A 77 year old male diagnosed with Alzheimer's disease presents with insomnia/WASO and agitation. He is started on oral A19-144 at 50 mg/day. Follow up at 30 days of daily dosing reveals he is sleeping well through the night and not waking up repeatedly. He is also less agitated. His results on all cognitive tests and HAM-D improve. He is currently maintained on 50 mg of A19-144 daily.
Example 10
Maintenance Insomnia Therapy in Alzheimer's Disease Related Insomnia and Agitation
(58) A 77 year old male diagnosed with Alzheimer's disease presents with insomnia/WASO and agitation. He is started on oral A1-41 at 30 mg/day. Follow up at 60 days of daily dosing reveals he is sleeping well through the night and not waking up repeatedly. He is also less agitated. His results on all cognitive tests and HAM-D improve. He is currently maintained on 30 mg of A1-41 daily.
Yes, the Story Will Be Global
Things Coming Together for Anavex and Blarcamesine
So, as a first step in getting blarcamesine approved for sale and use in Europe, Anavex has opened exploratory discussions with the European Medicines Agency (EMA), the European equivalent of the Food and Drug Administration (FDA) in the US.
Might this, then, portend a similar maneuver soon to follow, Down Under, in Australia?
Soon enough, blarcamesine for Alzheimer’s can be in regulatory consideration in three major pharmaceutical markets, Europe, the US, and Australia.
Then, in the middle of all of this will be the promised appearance of a confirmatory article on the efficacy and safety of blarcamesine in a clinical trail(s) report in a major peer-reviewed medical journal.
Getting ever more entertaining to read the ever more vacuous postings of the Anavex naysayers. When blarcamesine gets approved somewhere and people with Alzheimer’s start getting improved sleep and cognition, there will be helpful postings that the drug is actually a toxin and everyone taking it will die. ‘Big mistake. We know better. Should never have been approved....’
What gets talked about here?
All who read each day’s postings on this Anavex Life Sciences Corp (AVXL) investor message board soon recognize that most postings fall within just a few general message categories. Here is a list of the message board subject categories I just created:
1. Announcement or comment on a corporate news release.
2. Comment on the performance of a corporate executive, good or bad.
3. Comment, projection, or conjecture on future AVXL share price.
4. Comment on the timelines of corporate announcements.
5. Posting on the details of the science of Anavex’s molecules.
6. Posting on the details of various clinical trials.
What are the others? What else gets mentioned, talked about?
When we get a full list of message topic categories, in my idle moments I intend to examine a week’s worth of messages and see how many fall into each message topic category. No, not a comparison of naysayings against Anavex enthusiasms; merely a percentage breakdown on what gets talked about here.
The Market for a Safe, Effective Insomnia Drug
Not sure about Anavex? Read the Examples.
Ok, then. Let’s see a big trial.
From the announcement:
Thank you. Good thinking!
Nidan, I was lax in considering the wider application this new digital technology, which accurately and precisely detects Alzheimer’s and Parkinson’s Diseases biomarkers. I was looking ahead to when blarcamesine and Anavex 3-71 become available for clinical uses; to treat and/or prevent those CNS diseases. Good enough; but not as good (at least right now) for the good purposes you proposed; to use the device to cheaply, quickly, and accurately determine the status of CNS disease biomarkers during clinical trials of Anavex molecules. So much better than existing biomarker analyses.
Yep, as you pointed out (thank you), the device could optimize the testing of Anavex molecules in patients in new Anavex clinical studies. Quick. Easy. Accurate. The clinical trial game changes. Instead of years; months.
Device to Facilitate Anavex CNS Disease Prophylaxis