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Yes. I am expecting a very large payoff for my investment. And btw, the 25k shares today only adds to my total...which is well over 100k shares now.
But there's more to my investment than the expectation of wealth...
I firmly believe that Anavex is going to help a lot of people with neurological problems...including my wife - who suffers from TLE.
And who knows? In a few years I might need it for my own mental health...and so might you.
If it's one thing we've learned about TGD...it's his methodical approach to everything.
Rather than show the P2b/3 trial piece-by-piece, he has chosen to wait until everything is fully analyzed before showing his hand.
The fact that he wants to "surprise" the public with our full results, shows that he knows how to play the game...and frustrate the shorts in the process.
I'm really starting to like this guy! (Hence my additional purchase of 25k shares today)
Another excellent post. Thanks CKent.
1) Anavex has been approached by companies interested in either partnering on or licensing Blarcamesine. The fact these were unsolicited shows they are watching and paying attention to the Anavex's MOA, results, and peer reviews. There will be some competition to get a jump to secure access to Blarcamesine before their competitors, resulting in more aggressive up front offers.
2) Kun Jin coming on board may finally be bearing some fruit. The possibility of using the OLE as a confirmatory trial would surely expedite the AA process and eventually full approval. Hope more ripe fruit comes from him being on team asap.
3) Good to hear Missling state he wanted to "surprise the market" without projecting a more definitive timeline like CTAD. I know it's frustrating not knowing more definitively but this works to our benefit. There's more uncertainty for shorts to play games since they don't know when the rug will be pulled out from under them. "Surprise" has two meanings here. First, getting caught off guard for the shorts, and second, it projects very positive results. Afterall, he did state at the ASM that we will like the results.
Excellent post, bas.
I would also add the "digital 'Healthcare Sales Marketing' pharma platform" which could play a very important role in promoting Blarcamesine throughout the U.S. (and worldwide) once it is approved.
Very excited about this new AI technology.
Just purchased 25,000 shares. Most got filled at $7.90
LOL...I put that person on ignore last week. What took you so long?
Um...no. I'm sure he understands that perfectly. The purpose of putting you on ignore is to read the posts that really matter.
And frankly, he's right. Your posts don't contribute anything to this board...so I too am putting you on ignore.
Hope you enjoy talking to yourself.
Ciao
Once A2-73 is approved for Rett, Anavex can repurpose the drug for Alzheimer's Disease...which will expedite the approval process. (See explanation below)
Drug repurposing, or repositioning, is a strategy aimed at identifying new uses for already approved drugs, which fall outside their original medical indication. This strategy has led not only to the successful preclinical and clinical testing in multiple neurological disorders, but also to the reevaluation of disused drugs, epitomized by the remarkable case of thalidomide.
In recent years drug repurposing has covered a wide range of neurological disorders, from neurodegenerative and neuropsychiatric to drug abuse-related disorders.
Alzheimer’s disease and Parkinson's disease, for example, are the two most common neurodegenerative diseases, for which only symptomatic therapies are available, while neuroprotective drugs are still an urgent unmet need. They are therefore in the top list of neurological disorders for the investigation of repurposed drugs, targeting both the disease neuropathology and symptoms.
**************************************************************************************************
The FDA can approve an NDA (New Drug Application) with one successful P3 trial and the repurposing of an FDA-approved drug.
So, if the FDA approves A2-73 for Rett, that would qualify for the first half of our Alzheimer's application. The other half would be our P2b/3 AD trial.
IMO, this is the main reason why Anavex wants the FDA to approve Rett first. Once it is approved, they can expedite the entire process for our Alzheimer's application. (Qualifying for the $100M voucher is a bonus)
Our FDA guys know what they're doing...especially Dr. Jin.
I'm just sitting back and enjoying the ride.
Cheers.
Can you clarify your comment...because it begs the question as to how many "drinks" you and Dr. Grimmer had while discussing Anavex?
Can you recall what motivated Dr. Grimmer to volunteer that information?
Thanks
Anavex Life Sciences to Present at the BTIG Virtual Biotechnology Conference 2023
NEW YORK, Aug. 02, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer's disease, Parkinson's disease, Rett syndrome and other central nervous system (CNS) disorders, today announced that Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, will participate in a fireside chat at the BTIG Virtual Biotechnology Conference 2023, taking place on August 7-8, 2023.
The Fireside chat will take place on August 7, 2023, at 12:30 pm ET. A replay will also be available through the BTIG Virtual Biotechnology Conference platform.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX(R)2-73 (blarcamesine), has successfully completed a Phase 2a and recently a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients with Rett syndrome. ANAVEX(R)2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX(R)2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX(R)2-73 for the treatment of Parkinson's disease. ANAVEX(R)3-71, which targets sigma-1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX(R)3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter,Facebook, Instagram, and LinkedIn.
AVXL is the only stock in my portfolio that is green.
Does this mean the shorts are getting a little nervous?
Probably the best NDA roadmap I have ever seen. (Take special note of pages 16 and 26/27)
https://www.fdli.org/wp-content/uploads/2021/04/Mulkey-Elizabeth.pdf
Makes me wonder if this had anything to do with it? (Read both headlines below)
FDA Selects Ariana's KEM Platform for Biomarker Signature Validation
FDA has chosen to implement Ariana Pharma's KEM® (Knowledge Extraction Management) decision-support platform to facilitate data analysis for the validation of biomarker signatures. The technology will be used by FDA's reviewers to analyze pharmacogenomic and other data submitted through the agency's Voluntary Exploratory Data Submission (VXDS) program.
Ariana claims the collaboration will help FDA more systematically identify potential genomic fingerprints and develop recommendations relating to the analysis of genomic data prior to the submission of biomarker signatures. "We are looking forward to this collaboration to help the agency systematically analyze all equivalent signatures combining both genomic and phenotypic data, thus increasing chances of selecting the best biomarker signature," comments Federico Goodsaid, Ph.D., FDA's associate director for operations in genomics at the Center for Drug Evaluation and Research's Office of Clinical Pharmacology.
Ariana provides data-mining solutions and decision-support services for clinical and safety studies, drug discovery, diagnostics, and biomarker development. The firm's KEM platform is a rules-based method developed to mine data and systematically extract and manage all consistent hypotheses. Ariana claims the technology can be applied to biomarker discovery to identify the best subset of markers in order to maximize patient coverage, through the ability to evaluate heterogeneous information, including genomic, proteomic, polypharmacology, and clinical data. The firm also suggests that unlike existing numerical methods, KEM can generate and prioritize hypotheses, carry out more exhaustive analysis, and handle missing data. [From September, 2010]
https://www.genengnews.com/topics/omics/fda-selects-arianas-kem-platform-for-biomarker-signature-validation/
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Anavex Life Sciences and Ariana Pharma Collaborate to Accelerate Timelines and Improve Efficiency
October 5, 2016
[You see, one of the first things Dr. Missling did was to follow the FDA's lead in AI technology...so now both the FDA and Anavex are using Ariana's KEM technology to analyze data. (Not bad for a German, aye?)]
https://www.anavex.com/post/anavex-life-sciences-and-ariana-pharma-collaborate-to-accelerate-timelines-and-improve-efficiency
Great Story.
A House of Sticks Won’t Save You from the Big Bad Wolf
by Jay Martin
Picture this: a gym class, eighth grade. A line of students standing against the wall, waiting their turn to be measured. I was there, too, and when my turn came, the tape measure stopped just shy of 5 feet. That day, I earned a nickname that would stick with me for years: “Four foot eleven and a half.”
I was a late bloomer, a fact I came to terms with early on. I knew I would eventually realize my dreams, but it would take longer than I, or anyone else, wanted. This realization has been a constant companion, a prophecy that's unfolding just as I had expected.
Now, let's shift gears for a moment. Imagine a cold water fish.
Researchers at the University of Las Palmas de Gran Canaria, Spain, have been studying the effects of temperature on growth rates across a variety of species. Their findings are fascinating: when an organism is raised in colder than natural temperatures, its growth rate lags behind the average. Warm temperatures, on the other hand, have the opposite effect.
Consider the humble goldfish. If you raise one in warmer than natural water, it will grow at an astonishing pace. But its sibling, raised in colder water, will grow more slowly. Yet, when both reach maturity and are placed in water matching their natural habitat, they revert to the mean, and become indistinguishable.
There's one key difference, though: the fast-growing fish, raised in warm water, has a life expectancy reduced by up to 16%. The slow-growing fish, raised in cold water, lives up to 30% longer.
Why does this happen?
Warm temperatures speed up metabolism, leading to higher calorie consumption. It's a simple equation: more input equals more output. But the issue of life expectancy is more complex. As an organism grows, it uses its energy and resources for various activities - cellular replication, repair, and maintenance. If the rate of replication is so high that it demands resources that would have been applied to repair and maintenance, the organism grows with an abundance of tissue damage.
A slower-growing organism, however, has a more balanced distribution of resources. This ensures a strong and healthy foundation, reducing mutant cells, inflammation, and tissue damage. While these conditions may not cause trouble at a young age, as an organism ages and becomes more prone to disease, their vulnerabilities are exposed.
This principle isn't limited to goldfish. It applies to most mammals, reptiles, fish - and yes, humans.
This lesson, I believe, is universal.
Fast-growing trees produce soft, airy wood. Slow-growing trees yield hard, dense timber. As German forester Peter Wohlleben puts it in The Hidden Life of Trees, "A tree that grows quickly, rots quickly, and therefore never has a chance to grow old."
I see this principle at work among my friends, many of whom are entrepreneurs.
One friend, a software company owner, is always on the cutting edge of every emerging industry. He pivots with remarkable agility, captures market share, and is often recognized as a pioneer. Yet, his business hasn’t grown in the ten years that I have known him. He has had some phenomenal years, followed by some remarkably insolvent ones. Ten years later, there has been no actual growth, just a relentless pursuit of shiny objects.
Another friend built a seemingly mundane, blue-collar service business. For twenty years, he stayed focused on exceptional customer service and slow organic growth into new geographies. He eventually sold to a strategic competitor for a life-changing sum.
He was the cold water fish.
I appreciate concepts like this because I believe there are certain natural laws that govern us.
Investors seeking the quick win or the easy trade are the ones who get wiped out.
Entrepreneurs who fixate on shortcuts always face their day of reckoning.
Even my kids understand that a quick house made of sticks won’t save you from the big bad wolf.
So take your time. Be patient, and trust your process. Be the cold water fish.
Great post, tred.
Quote: "Dr. Kaufmann has played different roles, including site investigator, Principal Investigator, and DSMB member/chair, in almost 20 drug trials for neurodevelopmental disorders. In this context, he has been involved in virtually all neurobiologically-based drug trials for Rett syndrome."
Now THAT is impressive.
Thanks for sharing.
You have to have a market that will pay for your drug before you can make any money...and there's not too many people that can afford $3.2 Million for treatment!
$3.2 Million Gene therapy per patient. Initial market reaction is based on price shock and questions about reimbursement.
Some of the issues highlighted in article below.
https://www.investors.com/news/technology/srpt-stock-halted-sarepta-wins-fda-approval-for-duchenne-gene-therapy/?src=A00220
Looks like AVXL is taking a breather before it moves up another 50 cents.
I follow several other biostocks and they're not doing so well.
ANVS...........up a penny
BIVI..............down 25 cents after getting a nice pop a few days ago
BIIB..............down 75 cents but that's nothing for a $270+ stock
NWBO..........down a penny which is significant for that stock
SRPT............down over $1 and keeps falling. Heck, it's lower than before the FDA approved their drug a few weeks ago! The trend is definitely down for this stock. Watching its downward spiral is like watching death with a thousand cuts. You have to wonder what will it take to turn this around if it can't appreciate after FDA approval? (ouch!)
Quote: One can make a reasonably strong argument that having 2-73 approved for Rett improves the chances of approval for AD.
Yes. The FDA has two specific pathways for NDA approval.
1) You must submit two successful Phase 3 trials - but there are a few exceptions; or
2) One successful Phase 3 trial and the submission of that same drug (A2-73) for an already approved disease...which, in this case, would be Rett.
And frankly, I believe that was the original plan that Dr. Missling intended. So, it wouldn't surprise me if Dr. Missling follows through with that strategy. Especially if it increases his chances for approval and expedites his submission timeline.
This is where Dr. Jin's expertise and experience is most needed.
Will be over $9/share tomorrow if we get another day like this.
Would like to see more volume...but hey, I'll take it!
As you already stated, he could've used some boiler plate verbiage that is typical for incoming executives...but he didn't.
Read the words carefully:"I believe I can make a substantial contribution at this very important time in the Company’s transition towards commercialization.”
Doc,
What's your opinion on the recent insider purchase by Dr. Missling of 232,000 shares...with a current value of $1.9MM?
He already had 1 MM shares in his personal account. In all practicality, he should've sold those shares and reinvested into other "less-risky" investments. But he didn't! Instead he held onto those shares and added them to his stash.
IMO, a nice vote of confidence for the future of Anavex.
2H 2023
Again, that was "old Anavex" talking. Dr. Jin wasn't hired until Jan/Feb of this year.
Things change.
If you don't adapt to the new changes, you'll be stuck in the past...and miss the opportunities that lie ahead.
IMO, he's basing his (Feb-ish) prediction on the "old Anavex" that was under-staffed and overworked.
With all of the new hires, Dr. Missling now has Anavex running like a fine running machine.
We still have a few key positions that need to be filled...but we're very focused on what's on our plate now...so we should easily attain the goals that are set for 2H 2023.
Quote: "I get what your saying. I've been surprised at the dates I see on stories...2018...2015 .... So I get it. But I have a feeling we are hitting a new phase just now."
Yes. You hit the nail on the head!
We are definitely hitting a new phase. We have new people on board (like Dr. Jin - the top statistician from the FDA) that will expedite our data and present it with clarity.
And, with a staff of approx 40 employees it's obvious that we are now preparing for commercialization.
Been here since 2010 (with powerwalker and a few others) and I can assure you that we are definitely in a "new phase". The second half of 2023 will be the year that Anavex presents the TLR for the EXCELLENCE trial...and, even more exciting, the full data for the 2b/3 AD study.
Your timing is impeccable...especially with AVXL shares being pushed down below $10
Once 2-73 is approved, it will push the value of our pipeline to 10x...imo, of course.
AVXL is a Piece of SSSSSSS-SILVER!
LOL
Wow...AVXL is flexing its muscles today and will probably close in the green.
Even the XBI is clearly in the red.
LOL...it reminds of a quote by a famous golfer who had just made a very long 20-foot put.
Someone in the crowd yelled: That was pure luck!
The golfer looked into the crowd and said: The more I practice, the luckier I get.
Quote: "I think neuroinflammation is a great target for AD and drugs that regulate microglia/macroglia or promote M1 to M2 phenotype switching are reasonable to trial for this indication."
Wow...it's nice to see that you have finally accepted this MOA to address AD. (Very encouraging!)
Thanks for your perspective.
That's good DD. Thanks WM
Here's some additional history about Anavex and Dr. Missling's contributions to the company.
When Dr. Missling came aboard in 2013 the SP was about $1/share and the company was on the brink of bankruptcy. Below is the auditor's comments:
"The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As described in Note 1 to the consolidated financial statements, the Company had an accumulated deficit of $41,204,972 and negative working capital of $1,559,211 at September 30, 2013 and incurred a net loss of $3,700,046 for the year then ended. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Our opinion is not modified with respect to this matter."
/s/ BDO USA, LLP
New York, NY
December 30, 2013
https://www.sec.gov/Archives/edgar/data/1314052/000106299313006497/form10k.htm#page_33
Once they hired Dr. Missling in 2013, he successfully executed a plan to turn the company around.
Since then, the SP has increased 800%...now at $8/share...they have $150 MM in the bank and no longer in debt...the employment growth has exploded in preparation for the commercialization of their new drug, Blarcamesine. (See below)
2013...Dr. Missling is hired (Thank God!)
2014 = 4 employees
2015 = 7 employees
2016 = 10 employees
2017 = 10 employees
2018 = 13 employees
2019 = 16 employees
2020 = 20 employees
2021 = 25 employees
2022 = 38 employees
https://www.macrotrends.net/stocks/charts/AVXL/anavex-life-sciences/number-of-employees
I thought my post was pretty straightforward.
Confirmed... Missling exercised 500k shrs and sold 268k.
"Anavex Life Sciences Corp.'s President and CEO just picked up 232,000 shares"
I responded with the following...
Since Dr. Missling could've easily sold those 232,000 shares on the open market, I now consider them as a purchase...and thus, he's now invested $1.9 MM in AVXL shares.
232,000 shares x $8.15 (which is the closing price) = $1.9 MM
IMO, this represents a purchase from an insider. (Thank you Dr. Missling!)
That's very good news!
Since Dr. Missling could've easily sold those 232,000 shares on the open market, I now consider them as a purchase...and thus, he's now invested $1.9 MM in AVXL shares.
Welcome to the club.
Correct me if I'm wrong, but aren't most families with Rett children automatically covered by some kind of federal insurance program? (I can't imagine any family having to pay all of the special medical care that is required to raise a Rett child)
And if they are covered by a federal insurance program, wouldn't they automatically qualify to receive Blarcasimine once it is approved by the FDA?
Anavex has only one shot to get FDA approval for their P2b/3 Alzheimer's NDA...so they need to make sure they include all of the P1s, P2s and P3 trials.
Everyone knows that a successful P3 trial is worth its weight in gold because it's a double-blind, placebo-controlled study...and the FDA values P3 results over all of the other P1s and P2s trials.
And remember, our P2b/3 trial (with only 509 patients) is probably the smallest n that has ever applied for an NDA for AD.
Waiting a few more months to add the Rett P3 trial to our NDA portfolio is just common sense. TGD knows what he's doing.
Cheers.
abe
What are you smoking?
In light of today's PR, would you like to change your statement?
Quote: "Rett has a 20-25% chance of showing data later this year good enough for an NDA submission in early 2024 (potential decision Q3)."
Interesting. Thanks for that insight Raja.