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Your Arithmetic Is Wrong, Unchecked
The Whys of the New Employee
Today, Anavex Life Sciences Corp “announced the appointment of David Goldberger, RPh, MLS as Senior Vice President Regulatory Affairs.”
https://www.anavex.com/post/anavex-life-sciences-appoints-senior-vp-of-regulatory-affairs?mc_cid=f501bfbc9b&mc_eid=39975e48cc
What questions can be asked about this new employee?
1. Why did Anavex hire the fellow?
He’s not any low-level bloke of moderate skills or responsibilities. He’s an experienced medical/pharmaceutical professional, with “over 40 years of pharmacy practice and pharmaceutical industry experience.” He’s being paid an executive-level salary. Not cheap for Anavex.
Consequently, Anavex must think its money will be well-spent on this new employee. He is expected to bring useful competencies to Anavex’s efforts to get drugs approved for sales and clinical use (and not just in the US).
2. Why did this fellow choose to align the rest of his professional career with Anavex?
Why would he choose to sign on to a start-up biotech that has no sales revenues nor any product approved for sale? Would appear that he’s risking the rest of his professional career. If he and Anavex fail to gain sales and use approval for any of Anavex’s candidate drugs, what, then, will be the remainder of Mr. Goldberger’s career? “Well, that Mr. Goldberger tried his best at Anavex, but he made a big mistake. Anavex’s candidate drugs were simply failures, right from the start. Sad story. He shoulda known better! The rest of us did.”
This question has been asked when pondering other new Anavex high-level employees: What, exactly, might Goldberger have known or learned about the deep science and incompletely-revealed clinical evidence for blarcamesine and Anavex 3-71? Does he know only what posters (pro and con) on this message board know? Or, after an NDA (non-disclosure agreement) was signed, has Anavex taken Goldberger behind closed doors to scrutinize yet-unrevealed clinical data; information that prompted him to sign on with Anavex; information that obviated any subsequent risks for the rest of his professional career?
Selective reading of posts.
Thanks. We are all here to learn.
Thanks for posting. The totality of results.
Probably much longer than a month.
Maybe even better in humans.
The continued no-dose efficacy factor.
In the new journal article, the authors made this statement:
Key will be Anavex's NDA background data.
Anavex 3-71 Succeeds Again, Now, as a Prophylactic!
To accurately discern the findings of the new journal article, telling the findings of Anavex 3-71 in the treatment of early-stage Alzheimer’s disease in transgenic rats (with inserted genetics mirroring those of humans with Alzheimer’s), I pulled up the publicly available article preview here:
https://www.sciencedirect.com/science/article/abs/pii/S0197458023002257?via%3Dihub
The paper appeared in Neurobiology of Aging, Volume 132, December 2023, Pages 220-232.
Here are key points in the paper.
Of course, there have been previous journal articles telling the findings of blarcamesine (Anavex 2-73) and Anavex 3-71 (AF710B) in the treatment of human CNS disorders genetically inserted into the genomes of murines (lab rodents). Each of those studies revealed positive efficacies (treatments), along with profound safety (lack of obviating or severe side effects).
But this study was new, investigating the ability of Anavex 3-71 to prevent or minimize the onset of Alzheimer’s-like symptoms. Simply, can Anavex 3-71 provide prophylactic, Alzheimer’s disease prevention outcomes? If so, this therapeutic modality would be greatly favorable to therapies that first require the presence of full-stage Alzheimer’s symptoms. Prophylaxis (prevention) as opposed to treatment (after the disease has caused CNS damage).
The authors stated: “We tested whether daily oral administration of AF710B (10 µg/kg) in 7-month-old, preplaque, McGill-R-Thy1-APP rats for 7 months, followed by a 4-week washout period, could prevent Alzheimer’s disease-like pathological hallmarks.”
At this point, one very important observation. The transgenic rats were dosed with 10 micrograms per kilogram of rat body weight. The largest lab rats weigh no more than 500 grams. If the study’s rats were large, they were getting 5 micrograms of Anavex 3-71 each day.
This is significant. Most of the other Anavex studies in murines have tested blarcamesine, Anavex’s leading new drug candidate for CNS diseases. But in those studies blarcamesine was dosed in milligram multiples, not tiny microgram amounts. Simply, Anavex 3-71 is far more active than blarcamesine. It requires doses in tiny micrograms. Blarcamesine requires doses in milligrams, generally an order of magnitude greater than Anavex 3-71. The authors of the study elected to test Anavex 3-71, instead of blarcamesine. They had reason to believe, then authenticated, that Anavex 3-71 would be the more favorable drug. I believe that, eventually, Anavex 3-71 will supplant blarcamesine and become Anavex’s lead pharmaceutical.
But, did the new drug actually work? Here’s what the authors claimed, “Long-term AF710B treatment prevented the cognitive impairment of McGill-R-Thy1-APP rats.”
Now, if this could likewise operate in humans, which would be the preferable clinical approach to Alzheimer’s? Presently: “We’ve done the clinical tests, and you, indeed, have Alzheimer’s. It’s now time for you to consider taking any of the existing new Alzheimer’s treatment drugs. They are expensive, and work only for a certain period of time, but they might give you a few years with symptoms where they are now.”
Or, “You are now entering the period of older age, after the age of 50, when Alzheimer’s first appears. We recommend that you now start taking a daily tablet of this new Anavex drug. Without any severe side effects, it will prevent or stop any Alzheimer’s symptoms.”
Questionable treatment after Alzheimer’s has set in? Or, prophylactic prevention, to keep the disease from ever occurring?
Of course, the Anavex critics will contend, once again, that mice (or rats) aren’t men; that murine studies are not useful in predicting new drug treatments in real humans. Of course, those with that perspective needn’t read or consider anything I or the company or the journal article have presented. But, in fact, the morphology (structure) and physiology (function) of murine nervous systems of murines parallel those of humans. This is not a matter of brain size or relative cognitive abilities. Those are different. But the distinct neurological structures and processes are the same.
Here’s a key finding. The drug produced a “reduction in the number of amyloid plaques in the hippocampus and the levels of Aß42 and Aß40 peptides in the cerebral cortex.”
No better biomarker for Alzheimer’s treatment efficacy. Amyloid plaques are almost universally regarded as the functional cause Alzheimer’s cognition-loss symptoms.
Additional positive outcomes, too: “AF710B treatment also reduced microglia and astrocyte recruitment toward CA1 hippocampal Aß-burdened neurons compared to vehicle-treated [non-dosed] McGill-R-Thy1-APP rats, also altering the inflammatory cytokines profile. Lastly, AF710B treatment rescued the conversion of brain-derived neurotrophic factor precursor to its mature and biologically active form.”
The authors made this bold claim, “Overall, these results suggest preventive and disease-modifying properties of the compound.”
Succinctly, Anavex 3-71, when used before Alzheimer’s sets in, in a prophylactic mode, actually works. It prevents the onset of Alzheimer’s symptoms. In this case, of course, only in transgenic lab rats. But, as any future trials in humans will prove, the same prophylaxis will occur. Eventually, Anavex 3-71 will be Anavex’s prime drug.
Sorry, no mice.
Could this happen to Anavex?
Earlier today someone posted on the day’s explosion of the TPST (Tempest Therapeutics, Inc) share price. I clicked around to see what was up (beyond the share price).
Tempest, like Anavex, appears to be a small biotech start-up presently with no product revenues. The company, founded in 2017, focuses on innovative (proprietary) cancer treatments by “...developing first-in-class small molecule therapeutics to treat cancer through mechanisms that directly kill tumor cells and activate tumor-specific immunity.” Another small start-up biotech with no products to sell; just some “innovative” disease treatment concepts, centered on cancer and the immune system.
https://ir.tempesttx.com/
In a news release this morning the company announced that data analysis of a “Phase 1b/2 clinical study in which TPST-1120, Tempest’s PPAR antagonist, shows clinical superiority in multiple study endpoints when combined with atezolizumab and bevacizumab in a randomized comparison to atezolizumab and bevacizumab in the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma (“HCC”).
In combination with other drugs, the Tempest drug was shown to work for this particular cancer.
https://ir.tempesttx.com/news-releases/news-release-details/tempest-releases-new-data-demonstrating-superiority-tpst-1120
Obviously, the “market” liked what it learned (as though markets are personalities). At the close yesterday (10 Oct) the TPST share price was what it has been for some time, in the narrow range of $0.23. Then, this morning the news release was read and the share price ascent went up at a steep angle all day. At a good number of times during the day, the stock got a trading halt; apparently to cool things down.
At 4pm Eastern, the share price closed today at about $10.00; was varying drastically. Who knows where (or if) the share price will settle when after-hours trading finally settles on a price?
The day before, the closing TPST share price was $0.23. In 24 hours the share price increased and closed at, shall we say, $10.00. $10.00/$0.23 = 43.47826. In 24 hours, the TPST share price increased in value over 43 times; a percentage increase of 4347.83%.
If Anavex were ever to have a similar press release, announcing similar results for blarcamesine against Rett and/or Alzheimer’s, and the “market” responded accordingly, with an Anavex start price at a mere $5.00, the next day’s closing share price would be $217.39.
With even a fraction of such an Anavex share price increase, it would seem that a lot of wives of husbands betting big on Anavex failure, holding uncovered AVXL short positions, would like to learn just why this explosive price increase could never happen with Anavex. Please, tell us why the shorties and their wives are not at risk with such a scenario.
A "prevention trial" won't be needed.
Even more; much more.
Genetically-modified murines are central in the Anavex story.
A mouse model with GBS.
New Anavex Drug Patent — What else?
Well, Anavex filed for a new patent; to treat the seizures of epilepsy. How could this have happened?
Only by actually conducting experiments and studies of murines (lab rodents) utilizing Anavex’s proprietary molecules A19-144 and A2-73 (also known as blarcamesine).
Understand, Anavex simply is not revealing what the company is actually working on, with new molecules or new applications and indications for those molecules. All sorts of innovative experimentation going on at Anavex. Because of these closed-door studies, Anavex knows the deep extent and broad range of results their new drugs will yield in new therapies; for a widening diversity of indications.
In five years, the Anavex story will not be only blarcamesine for Rett and Alzheimer’s. Lots, lots more....
The new Anavex professionals tell the real story.
"SAP" is a clinical trial's 'Statistical Analysis Plan'
https://www.kolabtree.com/blog/how-to-develop-a-statistical-analysis-plan-sap-for-clinical-trials/
Diligent academic publication caution.
In the press release, Anavex states:
Pretty impressive. Anavex has won.
What could this guy be thinking?
The economic forces of Blackrock vs health insurance.
Dates count, do matter. My error.
Wrong year. Someone's original posting error.
Do Conference Planners Know...?
Is Dr. Klamer risking his professional career?
https://www.discoveryontarget.com/CNS-Neurodegenerative-Targets
It is interesting to note that at this conference (26 September, in Boston) Daniel Klamer, PhD, MBA, Vice President, Business Development & Scientific Strategy, of Anavex Life Sciences Corp, will physically appear and present his presentation’s information. Among many other things, the announcement noted that Dr. Klamer will contend that “ANAVEX 2-73 is an orally available drug candidate that restores cellular homeostasis by activating the sigma-1 receptor.”
Just who, do you suppose, will be in Dr. Klamer’s audience at this medical research professionals conference? Stock message board hacks off the street? Or medical professionals who conduct medical research? Might anyone in the audience challenge Dr. Klamer’s claims regarding blarcamesine (Anavex 2-73)?
It would seem that if, as many here contend, that Anavex doesn’t actually have substantiating safety and efficacy data from their clinical trials Dr. Klamer will have to offer some embarrassing equivocations on the topic.
Or — make your choice — Dr. Klamer knows full well that Anavex has the substantiating data, which will be revealed some time in the future. Although not likely to be revealed by Dr. Klamer at this Boston conference, he can confidently state that when the time is right, the clinical data from blarcamesine trials will substantiate all that he will be claiming at the conference, and will allow FDA approval.
Or, he will just have to make up answers to questions about blarcamesine and hope that all of the contentious issues fade quietly from discussion.
If you were this Dr. Klamer, would you put yourself before a roomful of medical research professionals knowing that the points in your presentation about blarcamesine simply lack evidence-based substantiation? Professionally pretty risky. Actually, career-ending.
What, then, might you suppose Dr. Klamer actually knows about blarcamesine? Is he risking his professional career by making this appearance and presentation? Or....
Who knows more about blarcamesine? Doc238 or Dr. Hagerman?
Another Valid Animal Model for Sigma-1 Receptor Biology
Down Under
Estimating Potential Gains from an AVXL Position
Have an AVXL position, a holding of the shares of Anavex Life Sciences Corp.? Or considering the acquisition of one?
It would then be useful to calculate estimated or potential values of such an equity holding. As I do about once a year I punched my AVXL numbers on a spreadsheet. Same numbers as before. No changes. All are estimations of potential values. If Anavex goes bust, the values will all be zero (except for the negative value of my sunk costs in acquiring my modest AVXL position).
I’ll give only some starting numbers; not my final number runouts. I’ll let each determine those for himself.
I presumed two different scenarios for Anavex. In the first, I presumed that at some time in the future blarcamesine would be prescribed and allowed as an anti-aging prophylactic; where a certain number of people would take a tablet of blarcamesine each day, to preserve health in the last half of life.
Of course, these numbers are only rather arbitrary estimates. In practice (should this all play out) the numbers could be larger or smaller. For prophylactic purposes I presumed that people taking blarcamesine would pay a dollar a day for the drug. Of that, I presumed that 10%, ten-cents, would end up going out to AVXL shareholders as dividends.
To be conservative, I then presumed just 300 days in the year; a total of $30 annually going out in dividends for each blarcamesine prophylaxis patient.
I won’t reveal the total number of patients who would be taking blarcamesine each year for prophylaxis. Estimate your own number.
At the same time, I estimated that there will be a total of 100 million (100,000,000) outstanding AVXL shares.
With those estimates, one can calculate the total amount going out in dividends. Divide the total funds available for dividends by 100,000,000; which will reveal the annual per-share dividend.
Then, multiply the size of your AVXL position by the per-share dividend. That’s your yearly AVXL dividends total.
The other calculation I made involved blarcamesine as a treatment for Alzheimer’s (some day). Same run-through. For this, I presumed each Alzheimer’s patient taking blarcamesine would yield to Anavex $1 per day that would drop down to dividends payouts. Again, to be conservative, I presumed only 300 days in the year. For each Alzheimer’s patient taking blarcamesine, $300 each year would go out in dividend payments.
Then, estimate for yourself how many Alzheimer’s patients would be taking blarcamesine each year. Multiply that times 300 and that’s the estimated dividends total for the year.
Divide that by outstanding shares, 100,00,000, and you have the size of the per-share dividend.
Lastly, multiply that dividend number times the number of AXL shares you have or will purchase. Your annual dividends number.
It’s clear. If blarcamesine gains sales and use approval, and it is used either as a cheap prophylactic, or as the standard of care (SOC) treatment of Alzheimer’s, just a tiny AVXL position will be very profitable. I have a very moderate AVXL position, acquired incrementally over many years with discretionary budget funds. I was astonished at the number of digits needed in my calculations.
Run your own numbers. Be aware of the eventual dollar-value potentials for an AVXL position, of any size.
Yes, Teachers Change Lives
Was I Like Someone's Biology Teacher? Apparently Not.
Anavex/Missling Have the Strong Hand
Well, you don't know. Others of us do.
Both cognition restoration and persisting cognition maintenance.
The Recent Share Price Trend
But, the FDA will be wrong with blarcamesine.
Not just the FDA; the broader market, now?
Lunchtime Talk at the FDA