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Anavex Discussion Topics
As a close reader, and not infrequent poster on this board, I note with some curiosity the general topic categories or themes the postings here take.
Here’s my quick list, in no rank order:
1. Efficacy and Safety of Anavex 2-73.
2. Diseases Anavex drugs might treat.
3. Mechanisms of Action of Anavex drugs.
4. Likelihood of a Big Pharmaceutical buyout.
5. Patent protection concerns.
6. Short-term share price variations and projections, particularly as “revealed” by technical analysis (“charts”).
7. Performance of corporate officials, particularly Dr. Missling.
8. Non-release or masking of clinical Anavex data.
9. Corporate announcements and event participations.
10. Potential drugs in the Anavex pipeline.
11. Past and future Anavex clinical trials.
12. Application of new Cures Act and expedited FDA Anavex drug approvals.
Those are my Dandy Dozen.
What other general topics are discussed here?
What topics, per chance, have we neglected?
That's a Good One!
Listened to the Anavex YouTube. Same as Here.
I listened to the YouTube presentation, where the presenter told why he recommends the taking of an AVXL position. He is an investment advisor focusing on low- and mid-capitalization young companies with anticipated growth prospects.
Simply, he merely stated most of the positives that have been stated so many times here on Ihub. I’m rather certain he didn’t derive his bullish Anavex sentiments from reading the postings here; rather, like a good number of us, he’s done rather detailed examination of all the available information on Anavex Life Sciences Corp and came to the conclusion, as so many of us here, that AVXL will be a rewarding investment, based upon the solid Anavex science.
I anticipate more such advisor recommendations when the Anavex science is more clearly affirmed by the three upcoming Anavex 2-73 clinical trials.
With the hard data from those, anticipated safety and efficacy outcomes will no longer be speculations or conjectures.
Gonna be fun to watch.
(And, by the way, I “reconsidered.” Thought long and hard— well, intently, for about five seconds, and never did liquidate my AVXL position this morning. Still in. Still strong. Still long.)
My Knowledge, and Experts' Presentation of Anavex Data
Doesn’t Anavex Threaten Alzheimer’s Experts’ Careers?
Is the frustration sensed?
Very Close! A Paucity of Negative Expert Testimony
You are telling us all that the Anavex story is phony, flawed, or contrived. Your expertise in relevant neurological matters is unknown. You base your contentions rather narrowly on the fact that neurological drug developments have, so often, proven to be failures. Therefore, Anavex, too, should necessarily suffer this fate.
None of us taking the time to read or post here on Ihub are ignorant of the record of drug development failures, particularly the many Alzheimer’s drugs that have failed.
Nor are we so ignorant as to effortlessly lump the unique, proprietary Anavex drugs in with the very different previous failures. We know better. We’ve scrutinized the evidence for the existing and failed Alzheimer’s drugs (and their untoward safety profiles), and compared that info with the large body of Anavex 2-73 data.
I contend, once again (un-rebutted), that were this the case, that were there gaps, smudges, or dirt in the Anavex story, as laid out in the several corporate announcements and the many pre-clinical studies on the Anavex molecules, one would expect to find others, more expert than you or me, to be sounding the alarms you post.
The paucity of expert testimony against Anavex is altogether telling.
I don’t recommend anyone take or dispose of an Anavex equity position based solely on any of my posts, whatsoever. Instead, peruse the postings and quotations from any number of authentic experts in related fields who have conveyed useful due-diligence information.
If Dangerous for Us, Why Not the Mutual Funds?
Negative Evidence Evermore Flimsy
The first leak of positive trial results from the short Rett or Parkinson’s Anavex 2-73 trials this winter is going to change the tone and themes of Anavex postings on this board. More importantly, the Anavex stories will ascend to national and international prominence, given the magnitude of the social and economic problems Anavex Life Sciences Corp will so successfully address. Imagine the headlines, yourself.
The desperation in posting negating “information” about the “untested, probably unsafe” Anavex drugs on this board will be ever more tenuous, if not, then, ludicrous.
Even as now, the due diligence of the many AVXL investors scrutinizing all of the Ihub Anavex postings will continue to suppress share sales and promote new, larger, stronger equity positions.
Those few with short positions, or those supporting such, really can’t be sleeping better each night. There simply has not been the expected, growing consensus, by any group, that the Anavex story is a flawed or contrived one. Just the opposite. Not a single PhD has been quoted claiming such. Many tens of thousands of shares continue be held and purchased by mutual funds. Professional organizations, such as the Rett Foundation and The Michael J. Fox Foundation (Parkinson’s Disease) are supporting Anavex trials.
The Anavex ship may still be docked in the harbor. But it’s not sinking by any means. It’s being loaded, and when it sails in 2018 it will both reward AVXL share holders and revolutionize 21st-century medicine.
Clearly, that guy from Texas doesn't know much about what he's talking about. All the posters here, do. We've got more collective knowledge about Anavex 2-73 safety and efficacy than any university professor studying Alzheimer's.
Just who'ya gonna listen to?
The real stories are here, from our real experts, aren't they.
So good to keep in mind when reading the complicated posts.
Then, What of the Political Pressures for Anavex?
Yes, a number of very moderately effective drugs have been approved to treat various cancers. I have noted the “fine print” disclaimer in small typeface in one cancer drug’s advertisements on the evening TV news, something to the effect, “This drug is not a cancer cure, and will only slightly delay the disease’s lethal outcome.”
I also contemplated (but did not actually determine) the surely very high cost of this drug. FDA approved a drug with giant, short-term treatment costs, with assured lethality. No cure; very poor treatment.
Ponder then, if you will, what might be the public perceptions and comments should it “leak out” early in the new Anavex 2-73 Phase 3 study that about half (figure out which that might be) of the Alzheimer’s patients in the trial were now sleeping well and had stabilized or improved thinking (cognition) abilities. Family members and care-givers would be telling friends about how Aunt Millie, after just a few weeks taking this new pill, is feeling so much better; talking sensibly to everyone, and no longer having problems getting or staying asleep each night.
“Hey, why can’t my husband be on that pill? We are gonna have to put him in a nursing home. I can’t take care of him any more? Why is the government keeping this drug from us?!!”
The social and political pressures for early, compassionate approval of Anavex 2-73 for Alzheimer’s (and also for Rett and Parkinson’s Disease) may be strong.
I will not be surprised if FDA is pressured (by you know whom — it would be YUGE), or congressional members, to terminate the trial and grant immediate compassionate use, once Anavex 2-73 performance levels leak out of the study. If they are anywhere as good as what happened in the Phase1/Phase2 Australian study, there will be no possible way to hide or mask the data. The word will get out; with, perhaps, some remarkable and early FDA approval outcomes.
Are the Aussies Still Getting Anavex Benefits?
Important question, but if negative not a game-ender.
Perhaps after an extended period, longer than the original quantified Phase1/Phase2 safety & tolerability trial, those continuing to take Anavex 2-73 fail to maintain baseline or increased cognition. Perhaps the drug works exceptionally well at the start, and for some good period thereafter (many months, to a year or more), efficacy then fades and the disease symptoms resume. If so, so unfortunate.
But even if this were the course of Anavex 2-73 Alzheimer's therapy, it would not negate or prevent FDA approval of the drug. As noted in a previous post, to get approved for Alzheimer's treatment, Anavex 2-73 must do two things: have superior efficacy compared to the few approved Alzheimer's drugs on the market, and have a superior safety profile.
The latter was well-demonstrated in the Aussie trial. And already, those continuing to successfully take the drug in the post-trial period demonstrate a superior efficacy profile. Existing drugs work for but a few weeks or months.
Our best hope, both for AVXL shareholders and future Anavex users is for perpetuating, continuing suppression of Alzheimer's symptoms. All existing evidence, both murine (rats and mice) and human, points in this direction.
But even if efficacy eventually fades, the drug will be superior to anything presently on the market. It would be approved.
FDA approval, of course, hinges upon the conduct and database from a proper Phase 3 study, to begin later this year.
A Conjecture: Selection of Those Vulnerable to Alzheimer’s
A study just published tells of ways to assess vulnerabilities to ensuing Alzheimer’s:
Important Point: Randomness of the 25
The Reality is This: Unique Efficacy and Safety
Fact is, no other Alzheimer's drug, approved, in testing, or failed, has the unique dual combination of outcomes matching or exceeding Anavex 2-73:
a) profound efficacy, where Alzheimer's patients either remain at baseline cognition levels, or actually increase cognition,
and,
b) profound safety profile, absent any Stage 4 and 5 adverse events (side effects), with the lesser adverse events mild and non-disqualifying (headaches, upset stomach, and the like).
Really, Which?
The Masking of Current Anavex Trial Data
Could it be that continuing results from those continuing with Anavex 2-73, following the formal closing of the Australian Phase1/Phase2 trial are being masked, unrevealed, for a very important reason?
Could it be that those post-trial results continue to be profoundly positive, that, perhaps all have experienced significant or total suppression of their Alzheimer’s symptoms, and because of this, the company wishes to keep these data hidden for now, for this reason.
If it became widely known that all of the Australian trial participants experienced profound relief from their Alzheimer’s symptoms after the extended dosage periods, would not this information taint pools of prospective Alzheimer’s patients for the upcoming Phase 3 double-blind clinical study?
Right now, very few know of, or believe, the famous (here, at least) Australian Phase1/Phase2 “graph.” But what would happen if the entire worldwide Alzheimer’s community discovered that several dozen Australians, continuing to take an Anavex 2-73 pill each day, now lead perfectly normal lives? Would that make it difficult to enlist properly naive trial participants, people (and their care givers) who have no pre-conceived ideas about the efficacy of the drug being testing in them?
Could the hiding of post-trial results keep Phase 3 trial critics from claiming that any positive results were, in fact, “placebo” effects, prompted by participants’ knowledge of and belief in the very positive outcomes Down Under?
A proper, valid Phase 3 trial is to be double-blinded. Neither patients (and their care-givers), nor medical people are to know whether or not the daily pills they are taking are real or shams. That way, the results are “pure,” untainted by human hopes or perceptions.
The hiding of any current Australian trials data may simply be a way to assure a valid double-blind Phase 3 clinical trial. Very well, and good. Intervening AVXL share prices have no standing in this matter. The long-term outlook and results will matter most.
Of Course Not
This is the world premier announcement of this new drug, never released to the public before just now, by me!
Watch for all of the upcoming announcements of the many other new,
revolutionizing drugs in the Antivex pipeline.
Wait until you hear about THEIR unique mechanisms of action.
Probably Not Helpful
Please, Substantiate Anavex 2-73 Results Worse Than Existing
Once again, to get FDA approval, Anavex 2-73 must show that its efficacy (symptom suppression) is at least as good as any drug on the market, and also that it has fewer side effects.
Show us, please, just how the existing drugs surpass Anavex 2-73.
In the Australian study, cognition was either maintained or improved over the period of time.
With current drugs, cognition is maintained only for short periods of time, ultimately with reversion to lethal progression. Every one of these drugs state emphatically that favorable treatment results are only for a period of time, with universal resumption of disease progression.
Can you show us an on-the-market Alzheimer's drug (approval competition) that matches or beats the symptom suppression profile of Anavex 2-73?
Can you show us a current Alzheimer's drug with a superior side effects profile?
Exact names of the drugs are requested.
Of course, in the absence of any of these, you will state that the Australian trial data are either incomplete or bogus.
Those of us holding our AVXL positions are confident the upcoming Phase 3 trial data will confirm the Australian data, and FDA approval will be forthcoming.
Those with alternative perspectives, respectfully, should not buy or own a single share of AVXL.
A matter of one's due diligence, of course.
Anavex Has Weak Competition
The Food and Drug Administration will not approval a new Alzheimer's treatment drug that fails to eclipse the "standard of care" drugs currently in use.
To be approved, any new drug must do two things.
A) Have equal or surpassing suppression of disease symptoms.
B) Have superior adverse events occurrences and severities.
It's got to work as good as what's on the market, and be even safer.
Peruse the characteristics of current Alzheimer's drugs:
New Cell Science for Big New Drug
Newly-published information in three peer-reviewed science journals gives a much fuller understanding of just how cells really function. And this relates directly to a new multi-phasic treatment drug, Antivex 7-23.
In animals, (rats and mice) Antivex 7-23 remarkably restores full function to dysfunctional neurons whose midichlorians no longer efficiently convert fats, sugars and salts into adenoseen trifrustrate (ATF).
Midichlorian-mediated oxidative stress causes cardio-myopathy in Type 2 diabetics. Therefore, Antivex 7-23 promises to be a cure for both Type 1 and Type 2 diabetes.
Midichloarian dysfunction is associated with any number of diseases, well-known and obscure, from cancers and heart disease, to Dorglemyer’s Hyperextensive Pedosis and Frumtpton’s Non-conjunctive Osteoneosis.
Antivex 7-23, if ever thoroughly tested and approved by the FDA (new clinical testing approaches will make this likely some time in the next decade), will revolutionize medicine, treating a host of diseases as never before.
I’m awaiting the company’s IPO. I’ll be buying as many shares as I can afford. I might even volunteer to be a moderator on a new Ihub board for the new company, Antivex Living Sciences Corp.
For those interested, scrutinize the profound new science here:
https://www.livescience.com/59927-midi-chlorians-paper-accepted-by-journals.html?utm_source=ls-newsletter&utm_medium=email&utm_campaign=20170726-ls
I’m Here, Will Stay, Will Post
Thanks. I’m not offended, angered, or frustrated with any of the posts questioning any of mine. Have had years of experience with such.
I spent 30 years teaching science, in my last 18 years to honors high school students who loved to question and assail the college-prep biology I imposed upon them.
In fact, I actually encouraged prying, scrutinizing, and leveraging questions. “Hey, Mr. Biology, you just said this, but that’s not what the textbook says. They gotta know more than you do. What’s up with all of this?”
Now, imagine, just how did I respond to this piercing challenge to my intellectual integrity?
In every such case, I said, “Well, Sam, you really questioned all of the information on the subject, just as a real biologist or scientist does. Because of that piercing question, you just got five extra credit points on your next test, next Wednesday. Good thinking, well said. Now, here’s my answer to your very good question. On this point the textbook has old, out of date info. Here’s the real story....”
Yes, a number of us are having delightful and informative, if not authentically contentious “discussions” on a number of important Anavex topics.
I wouldn’t (and won’t) be here when a broad diversity of perspectives don’t appear. It’s all good, for all of us. Let it all continue.
And I’m But an Ignorant Retail AVXL Bloke.
What do these owners of tens of thousands of AVXL shares know? Perhaps it’s the same info I know, from which, I, too, took an ever more confident but flawed AVXL position.
Our shared ignorance of the failed science and fraudulent reports of Anavex clinical trials is going to be interesting to follow.
Perhaps I’ll take some notes as we go along. Could be a book in the waiting, telling how both ignorant retail blokes like me out here in flyover lands, as well as top-level financial institutions got hoodwinked by some clever Anavex principals.
Stuff they should be teaching in the schools of business administration.
Inconsequential.
Now, come on. Just how could the apparently near-universal request for Anavex 2-73 dosing after the clinical trial ended by trial participants and their care givers be of any consequence?
After reading the multitude of so-helpful, definitive reports on this board, everyone knows that the extended post-trial Anavex 2-73 dosing requests were either a) plainly bogus, didn’t actually happen (more misinformation from the company or its supporters), or b) Australians simply have a stronger hope that something being tested on them might eventually work.
Here, we know for sure (Do we not?) that Anavex 2-73 simply did not and cannot produce relief from Alzheimer’s symptoms of any kind—no different from any of the dozen or so other candidate Alzheimer’s treatment drugs that have all failed.
Not only that, several posters here have questioned the exceptionally low incidence and weakness of the Anavex 2-73 adverse events (side effects) reported in the Australian study. Aren’t those Aussies hard to figure out? They had frequent and severe side effects (which Anavex conveniently didn’t properly report, using fragmentary statistics, it is supposed), but still, the Aussie trial participants universally begged the company to continue with the pills after the study anyway.
“Doc, during the study, I really felt like I was going to get better. I had lots of tummy and headaches after popping that pill each day, but I can handle it. Please, please, give me another 3-month’s supply. This is gotta work, somehow, someday. Now, where did I put my car keys?”
Just can’t figure out the Australian mind set, can we?
Or was this a very clever and devious selection process Anavex used, to enlist in their study only weak, easily-controlled minds, who could be subtly and surreptitiously persuaded to continue to beg for the pills after the trial.
Pretty clever, them Anavex clinical researchers. What a clever way to make blokes like us here think Anavex 2-73 really did suppress and reverse Alzheimer’s symptomatic progression.
Just like with the sneaky symptoms plot, we’ve been fooled again.
My Understandings of Mechanisms of Action Incorrect, Too?
My incompetencies in statistical analysis have been clearly laid out. That matter is settled.
Understand, however, I took my small AVXL position not by statistical validation of early human trial data (as flawed as they were); rather, by my (very competent, dare I say) understanding of cytology, intracellular molecular reaction pathways, enzyme-moderated cell chemistry, etc.
Most impressive to me have been the detailed explanations of the unique mechanisms of action of Anavex sigma-1 receptor agonists, telling, in any number of the peer-reviewed technical papers I’ve scrutinized, exactly how the Anavex molecules do what they do in dyshomeostatic cells, particularly neurons.
Consider this notion. The success of any of the several Anavex sigma-1 receptor agonists depends not upon precise statistics or analysis. The molecules simply have to biochemically restore homeostasis in dysfunctional neurons and their nerves. If that can happen (and it has been conclusively shown in both murine and human cells that they do this), the statistics of the matter are utterly irrelevant.
No one (even the experts scrutinizing the posts on this board) have ever presented any evidence-based or even theoretical evidence showing that the Anavex molecules don’t work in dysfunctional cells, that the putative mechanisms of action in restoring normalized mitochondrial/endoplasmic reticular connections, facilitating normalized Ca++ ion exchanges and adenosine triphosphate transport, allowing the rough endoplasmic reticulum to synthesize properly-folded enzymes, don’t actually occur.
I’m no longer interested in the statistics of the matter. It’s cell chemistry that will control the success of Anavex Life Sciences Corp. Not a fragment of evidence has ever been discovered or shown that the Anavex sigma-1 receptor agonists don’t or can’t work.
Our competition or deciding factor is not high-level, good statistics. Rather, Anavex is up against just two drugs. Memantine, a not very helpful drug useful only for moderate-to-severe Alzheimer’s patients for which acetylcholinesterase inhibitors have not worked or been tolerated; and Aricept (donepezil), an acetylcholinesterase inhibitor of limited efficacy and duration (with side effects).
Those are the Standards of Care for Alzheimer’s. If Anavex 2-73 can show even the slightest symptomatic improvement beyond the few weeks or months of Aricept, Anavex walks into every pharmacy in the Western world.
Now, of course, my critics will be quick to show I’m wrong on this, too; that absence of Stage 4 and 5 adverse events (disqualifying side effects) in the Australian study can’t be relied upon. Too few patients, no controls, all the rest.
But, I’ve read a dozen or so peer-reviewed technical reports where studies have assessed adverse events in variably-dosed rats and mice. Nothing of adverse consequence at therapeutic dosages.
Statistics aside, the Anavex science is solid and real.
[Eager to learn from other biologists just how the Anavex murine and human cells results could be in error, how the described mechanisms of action are in error.]
I’ll be keeping my shirt, after all.
It’s Settled; Noting Works. Everything Is Placebo.
So, I haven’t the statistical expertise to properly “interpret” what the Anavex graph so rather clearly shows. Somehow, that plot wasn’t real. Thanks for that so-helpful info. I’ll stop looking at Anavex data plots. They can’t possibly mean what they show, can they?
All previous Alzheimer’s drugs have simply failed in clinical trials, so therefore Anavex’s, too, must be a loser. That chart showing stabilization of cognitive assessments at the start, with a can’t-be-believed increase (plot line ascension) at the end. This somehow is either a statistical mis-representation (a corporate lie, SEC be aware), or the company, for purposes readers will have to determine, simply failed to provide a more advanced statistical analysis that would present the truth of the data. Anavex should consult and retain my critic (to his credit).
Once again, because of our collective inability to properly read graphed data plots, we are all at risk of losing our investment shirts, the ones with “AVXL” printed in big red letters on the back.
Still can’t figure out why the statistical analysis community has been so quiet on this matter. With many millions of dollars at stake, both in corporate coffers and in retail equity owners’ accounts, one would think that any number of statistically competent professionals would have, by now, pointed out the gross errors of the Anavex plots?
It’s now very clear. No drug, none of the many former failures, nor anything in the Anavex pipeline, can possibly treat Alzheimer’s. Any putative positive results must be merely artifacts of incompetent statistics.
I’m really mad. Those Anavex PhDs and MDs put that plot up on that slide, and they completely fooled me. So little did I know. I’ve been shown the fool I really am.
Pity me. My apologies to all I’ve so woefully misled on Anavex. I really got hoodwinked, didn’t I? So little did I know.
We can all liquidate our positions just before the open tomorrow, and then sit back and watch the insiders and institutional owners get their accounts cleaned when things start to fail this fall. They must know even fewer statistics than me.
Why Only an Anavex "Placebo" Effect?
Another Start-up Pharmaceutical Gets FDA Fast Track Designation
Slide 13 Error, Slide 26 Significance
https://seekingalpha.com/article/4080859-anavex-life-sciences-avxl-presents-jefferies-2017-global-healthcare-conference-slideshow
In a list of confirmed effects of Anavex sigma-1 receptor agonists, this is listed:
But, Once Again, Where are the PhDs?
Several recent postings have questioned management competencies, failure to present "hidden" data, and the putative mis-representation of released data.
If these, especially the mis-representation of data, are legitimate, why have there been no experts, real PhDs and MDs raising important investor questions?
Are AVXL shares sold or purchased only by lay retail people? Do physicians and research PhD types simply never take AVXL positions, so there are none with an interest to accurately assess the known Anavex data?
I marvel at just how the several Anavex-deprecating posters can so thoroughly tell us unknowledgeables all that exists behind Anavex doors, and what data sets they have that haven't been released. Moreover, they have told us just why the info is hidden, either because of corporate incompetence (for which the commentators are apparent experts in), or because of corporate skullduggery---for which the SEC should then take action.
I'm getting really concerned. I might sell my entire position at the opening on Monday. (Ha.)
Anavex Presentation at CNS Diseases Summit 2017
http://www.giiconference.com/gtc515394/cns-partnering-deal-making.shtml#day1
CNS Diseases Summit 2017
Date: September 11 - 12, 2017
Venue: Hyatt Regency Boston, Boston, MA, USA
"This meeting provides an interactive learning and relationship-building forum for all players in the CNS field. Colleagues from industry, academia, government agencies, and financing bodies will gather at the interface of research, partnerships, funding, and commercialization to find ways to move forward in a field that has been troubled with clinical failures.
The program will provide a comprehensive look at the current state of CNS, from research to commercialization. Above all, this event will provide networking opportunities in an intimate and accessible environment."
Abstract of Anavex presentation by Daniel Klamer, Vice President, Business Development & Scientific Strategy, Anavex Life Sciences
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded clinical stage biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders. Anavex’s lead candidate, ANAVEX 2-73, is an orally available compound that restores cellular homeostasis by targeting Sigma-1 and muscarinic receptors. ANAVEX 2-73, has demonstrated good safety, bioavailability, and tolerability in Phase 1 and Phase 2 clinical trials. In addition, data from an ongoing Phase 2a clinical trial in Alzheimer’s Disease demonstrates dose dependent cognitive improvements. The compound also exhibits anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat a broad range of CNS disorders.
ANAVEX 2-73 significantly improves multiple behavioral phenotypes in the Rett Syndrome mouse model in a dose-related manner. Based on these data, Anavex Life Sciences will start a U.S. multicenter Phase 2 clinical trial of ANAVEX 2-73 for the treatment of Rett Syndrome with the support of Rettsyndrome.org.
The Michael J. Fox Foundation for Parkinson’s Research awarded Anavex Life Sciences a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s Disease. Ongoing preclinical research in this therapeutic area demonstrates that ANAVEX 2-73 ameliorates motor deficits in spontaneous rotational activity and forelimb use asymmetry, and exerts significant neurorestorative effects on the damaged nigrostriatal dopamine system.
The scientific rationale, preclinical data, and clinical development path of ANAVEX 2-73 as a novel treatment strategy for Rett Syndrome, Parkinson’s Disease, and Multiple Sclerosis will be discussed in more detail. This presentation will explore the links between preclinical findings and clinical trial development trajectory in our ongoing translational research efforts.
Another Expert on Board. He Knows the Story
This new Anavex Life Sciences Corp advisor simply would not accept this position unless he knows all of the behind-the-lab-door info on the Anavex molecules.
Like the other Anavex professional advisors, this fellow certainly would not jeopardize his professional credentials by aligning with a tiny start-up drug company with "unproven" new drugs, unless, he was convinced of their validity.
He didn't sign on with Anavex without scrutinizing every bit of internal data the company has generated. He liked what he saw.
With "Gut Feelings," I Fight (Set) Wildfires, Too
Fireman, I connect directly to your "gut feelings" factors.
Here in Ohio I'm an Ohio Certified Prescribed Fire Manager, and plan and conduct many hundreds of acres of native tallgrass prairie and oak savanna prescribed fires each spring, to control brush invasion (with never an escape or adverse event).
You are so right. With the control of either prescribed fires or wildfires, nothing beats experience and a close discernment and perception of everything happening with the fire. Gut feeling, as it were.
Actually, superbly intelligent perception, diligence, and response are the factors of success. "Gut feeling" is just shorthand for all of that. Only a portion of that can be learned in books and training sessions. Experience, hard work, and comprehension in the field are the real factors of safety and success.
So it is, I believe, in investing in a start-up pharmaceutical like Anavex. When I first read of the detailed scientific reports (from lab work on animals) telling the unique mechanisms of action of the Anavex sigma-1 receptor agonists in neurons, my undergraduate biological training (cytology, molecular biology, etc.) caused me to have a pretty strong "gut feeling" that, hey, this could be IT. Everything seemed to fall into place, and for the first time (not before, with the protein waste-clearing or acetylcholinesterase inhibitor Alzheimer's drugs) this new Anavex biology looked like it would work against Alzheimer's.
At the start, for me, only a "gut feeling." Now, several years later, after reading several dozen scientific papers on the Anavex molecules, my confidence in them is way beyond a mere gut feeling. The science is real, as the up-coming Phase 3 clinical trial will eventually substantiate. The shorter Rett and Parkinson's trials may prove the biology sooner.
And, as you know, much of the share price ascent of Chesapeake Energy derived from that company's extraction of large flows of natural gas and petroleum from the Utica and Marcellus shales fractured here in Ohio.
Wish I would have been able to get in when you did. My minor was geology, and knew of the embedded hydrocarbons in the Devonian Shales under Ohio and Pennsylvania. Just didn't have any free investment dollars at the time. Congratulations on that investment.
When you ship out to the West or to Canada, stay safe and in touch with your crew(s). The termination of the drought, with massive winter snow packs and spring rains, as you know, have caused explosive growth of vegetation, creating gigantic fuel loads. My best wishes. Stay safe.
AAIC Clinical Trials and New Alzheimer’s Drugs Report
An article on the 2017 Alzheimer’ Association International Conference (AAIC) in London states, “Twenty-seven Alzheimer's drugs in Phase III clinical trials and eight drugs in Phase II clinical trials may launch in the next five years,....”
https://www.eurekalert.org/pub_releases/2017-07/apa-2pi071417.php
Note these comments:
Sales Price Will Not Result from Production Cost
This is a big question. After FDA approval for any of the several central nervous system diseases Anavex 2-73 will treat, how much will Anavex Life Sciences Corp. charge for a daily dosing? Will that price reflect in any significant way the cost of the dose’s manufacture?
If that’s the major fraction of the drug’s sales price, it will be very low. With the greatest dose concentration of, say, 50mg, that’s 20 doses per gram, or 20,000 per kilogram. If it were to cost, say, $400 to make a kilogram of Anavex 2-73, each dose would cost $0.02.
At ten times that, a dose would be $0.20. And for some conditions, optimal dosing may be less than 50mg.
No drug is sold solely at manufacturing cost. Anavex will want to recover, over time, at least, testing costs, marketing (drug representatives going into doctors’ offices to explain the drug), etc.
No way to know with any accuracy the eventual sales price of Anavex drugs. Will be interesting to see how the company elects to price their products.
Interesting Ethnocultural Health Study, re Alzheimer’s
The NYT article tells of a researcher living with (and in) a tropical aboriginal ethnic group in a deep wild area in South America. He’s studying (among other things) the reduced occurrence of Alzheimer’s in this group of people. They have relatively high rates of infant mortality, but compared to Western populations elevated rates of aged people in good physical and mental health.
He correlates this to the putative incidence of tropical parasites in the population, where the parasites keep certain gene expressions from causing astrocytes, nerve-nourishing cells, from turning on nerves. With the presence of parasites, the astrocytes are focused on suppression of the parasite infestation, not inadvertently against functioning nerves.
I derived two points from the article.
First, should the researcher’s thesis be proven (not sure just how that could happen; will be no double-blind clinical studies with these people in this remote area), I don’t see how any Western population could or would be infected with a parasite for Alzheimer’s prophylaxis. The parasite, a worm or microbe, might, indeed, reduce or prevent the onset of Alzheimer’s. But the other health-deprecating effects of a parasite could be as bad as Alzheimer’s itself. The legal and ethical problems with the administration of an Alzheimer’s-preventing parasite seem overwhelming. I can’t see it as a solution in any realistic way.
The second, unrelated point I took from the article is this (I knew a bit about this before, further described in the article). Very important for the Anavex story.
A good number of elderly people, in normal mental health (without any Alzheimer’s symptoms), actually have brain concentrations of beta-amyloids and tau tangles equivalent to those with Alzheimer’s. Neurologists continue to ponder just why these folks had no Alzheimer’s, but had giant waste protein accumulations that are so closely correlated to Alzheimer’s.
The key point is this. Some people have normal brains and full cognition even with high concentrations of the waste proteins otherwise thought to cause Alzheimer’s dementia. What could that mean?
Waste protein accumulations are not the sole cause of the dementia of Alzheimer’s; there must be at least one other factor. Might that be (here it comes) neuron dyshomeostasis resulting from mitochondrial/endoplasmic reticular dysfunction, the exact thing Anavex 2-73 corrects?
Virtually all central nervous system diseases are recognized to be a result of or closely associated with mitochondrial dysfunction. The Anavex 2-73 sigma-1 agonist (among other good things) reconnects mitochondria and endoplasmic reticula, restoring proper, healthful, normal neuron function (homeostasis).
With this, the neuron can once again produce properly-folded, fully functioning enzymes, which control virtually all cell chemistry. It is apparent, then, that the enzymes to remove protein waste accumulations are not the only ones to facilitate healthful neuron and nerve function. There must be others, that allow normal synapse function, allowing normal nerve function — no dementia.
I’ve contended all along that the main reason Anavex 2-73 so wonderfully stabilizes or improves Alzheimer’s symptom profiles is because the drug’s restoration of neuron homeostasis allows production of waste-clearing enzymes.
Well, it might be something different or more. Now (with this new knowledge) there is the possibility that after Anavex 2-73 gives Alzheimer’s relief, the patients may still retain high concentrations of the waste proteins, but now without the symptoms they putatively always cause (well, not always, as noted in this article).
In short, Anavex 2-73 may suppress dementia by some mechanism other than the normalized facilitation of protein waste removal.
This might also be a hint (but unknown mechanism) why the drug and its analogues work against other CNS diseases not complicated or caused by beta-amyloid or tau protein wastes. Something bigger and better may be happening, more than waste protein clearing.
Anavex 2-73 may promote healthful astrocyte functioning, keeping these cells from attacking neurons or nerves.
Would like to learn of this. Link?
(NYT Alzheimer's article.)
I Will Continue to Post, But Not Respond
As a retired biology teacher, it is my delight to explain the biology of the Anavex molecules. I will continue to do so. I will not, however, respond to murky, lame, nebulous, or un-referenced questionings of my postings.
The following comes to mind.
The Race is about to begin. Three Anavex horses are being nudged into the starting gate, one racing against Rett Syndrome, another against Parkinson’s, and the final against Alzheimer’s — the three up-coming Anavex clinical trials.
How might this race go?
As some here have implied, all three will stumble and fall into the dirt, never approaching the finish line. The horses are weak and have no ability to run the distance. Their failures in each lane will be the end of Anavex and this board. Fortunately for those seeing this outcome, they had the good sense never to take an AVXL position. Instead, they kept warning of the impending doom of the company. They saved many from financial losses.
Or, might the race turn out as follows, in any one of these potential winnings.
The gate opens, and off they go. The Rett and Parkinson’s horses cross their finish lines first (they run on a shorter track, just 12 weeks long). The Alzheimer’s horse has to circle the track several times, a one-year trial. But it gets there safely and “wins,” too.
All three of these horses end up in the winner’s circle, and take their prizes, FDA approvals. Anavex is, so to speak, a Triple Crown winner.
And, still out in the lab “pasture” are other Anavex “horses” (molecules) of the same lineage, awaiting their race times. One, Anavex 3-71, in early “training” (lab work on rats) reveals it’s stronger and faster than Anavex 2-73, particularly for Parkinson’s.
Those of us who have taken an AVXL position have placed our bets already. We’re ready for race day. Those who see the Anavex horses as weak and lame won’t be at the track. They will read of results in the Wall Street Journal, or even perhaps on the front page of the New York Times. “New Drug Gives Solid Hope for Alzheimer’s.” “Rett Girls Can Now Be Treated.” “Parkinson’s Disease Can Now Be Fixed.”
And those who watch any of the Triple Crown races watch frequent interviews of the owners and trainers of the horses in the race. The Anavex trainers are world class. The head trainer, Dr. Missling, is top notch. I don’t expect to lose any of the three races. He doesn't enter races his horses can't win.
But after any one of those three wins, I won’t be cashing in my betting ticket for several or many years — if at all. My AVXL shares will stay in my possession while Anavex stud fees (dividends and share prices) continue to escalate.