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NORMAL TIMING: "The study is set to conclude in November, with topline assessment results available by the end of the year, the company said. "
yeah, given Rett is pretty much the same as the previous trial, would like to see Topline data out by end of August.
As for alz, full data dump ASAP
This stock is pure dogschitt. Amy gain is immediately given back. Short with IMPUNITY on ANY 20 cent pop.
Do we really think that the powerful biopharma industry and their fellow travelers will just step aside, letting tiny Anavex waltz in and be greeted by an unbiased FDA
all the deep state bureaucrat types that frequent this board swear on a stack of Bibles that the bureaucrats are all 100% honest and only care about what is good for DC, er, America.
and with 3 elite FDA bureaucrats on our team, fast track to approval is guaranteed.
Full Presentation for AVXL P2b/3 top line results at CTAD 2022 Dec. 1, 2023
"The study is set to conclude in November, with topline assessment results available by the end of the year, the company said. "
Wow....They must have a baker's dozen ex-FDA'ers working for them to commit to release results within a month or two.
Good thing they are not waiting on a peer publication to inform their shareholders.
As I understand the current system there is no mechanism available to prevent rehypothecation i.e. relending out shorted shares.
To solve that problem will require a tag or a serial number to be associated with every share that follows that share as it is traded. That way a short created share can be identified and not reloaned.
That is something blockchain technology is good at.
The level of shorting for Anavex is not out of line with other developmental biotechs.
Anavex Life Sciences (AVXL) Outperforming Other Medical Stocks This Year
https://finance.yahoo.com/news/anavex-life-sciences-avxl-outperforming-134008140.html
Good luck and GOD bless,
Do we really think that the powerful biopharma industry and their fellow travelers will just step aside, letting tiny Anavex waltz in and be greeted by an unbiased FDA ...and on the grade-school-playground basis of "fairness", get approved to effectively destroy the multibillion income streams they've worked so hard to create for themselves??
Right, my only point was that systems should have been set up to prevent that kind of hold up from happening. Data should have been collected all along, validated all along, and when the last patient data is available then the whole data set should be release-able.
Nidan.....Biogen and Eisai appear to be a step closer to complete approval of liqembi despite adverse effects. One would think that this a good president for 2-73 and its outstanding safety record....Biogen and Eisai have lowered the bar and the public should opt for the "better" efficacy and safety of 2-73.
https://www.biospace.com/article/fda-indicates-potential-full-approval-for-eisai-and-biogen-s-leqembi-ahead-of-adcomm/
no way to know if the game is rigged, or just that the desperation for an alz treatment is high. . ????
NO? With The Supremes being offered. and accepting luxury gifts, private plane trips, stays at isolated private villas to talk with American business tycoons, smoking Cuban fat ones and drinking booze we've only heard of...
If they walk, talk, and quack like a duck.....they're ducks![
The December AD problem wasn't a matter of systems. One CRO site in Germany for some unknown reason was absurdly slow to go through their data and permit the data to be locked. It wasn't Anavex's fault and it was far out of line for that CRO to be so slow. I don't anticipate it happening again.
Hoskuld, I'm sure you knew all that. So maybe I missed your point.
In a rare, for me, complaint, everything is taking "too long".
I believe it's the frugal mindset which is sometimes good and sometimes bad, but I believe the rate of progress will accelerate in due time.
Remember Biotech isn't for everyone.
shorty will have a bad days ahead of them.JUST HOLD ON TIGHT LOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOONGS
NO kidding
Good results for Alzheimer’s with peer reviewed and good results for Rett should reprice the stock
Overnight to a higher level
Shorts covering will help
So where will shares for investment pools come from and what will be the new base where this occurs? 40 or 80?
What will be the value assigned to this company xxxxx and why would anyone sell because if results are good there won’t be much of a pullback for a while before company reaches fair valuation
Joseph, the AD results took way too long to get: that they received the data (and did the computations as you described) just before their december presentation timeslot was...crazy! Will the PD results also be subject to the same process? Today, electronic systems are usually set up to avoid that delay and confusion. Did Anavex use electronic data gathering tools for the Excellence trial?
ANVS running ahead of AVXL again.
get that PD trial going, Dr. M
get those p3 alz full results out
get the top line Rett excellence data out
by the end of the 3rd quarter.
URGENCY REQUIRED
Agreed, but.... I had incorrectly assessed the state of the industry as it applied to short stock, as did everyone except the "stonk marketeers", when the Meme stock short squeeze happened. It was honestly among the freaking coolest market events I've watched unfold.
Not to go too off topic, but that event put a microscope on the industry and revealed just how flawed the margin rules of hypothecation, rehypothecation and the back end accounting by the DTCC and ex-broker clearing systems allowed to be created extreme levels of short stock to remain in the system and the fact in practice over 100% of the float be shorted. I'm doubtful reforms will be made to correct the system at this back office level as there is too much money to be made, but there are some proposals currently being reviewed that create more disclosure and reporting. IMO most current proposed changes to short disclosures are weak.
Bottom line is that this flawed system remains in effect and COULD make for upside fireworks should any positive binary event for $AVXL occur and of course would be nice, but short market participants learned from the past and hedging strategies have been implemented and adjusted so I think a squeeze effect will be tempered. Regardless of the details and of hedging, on the most basic level the shares shorted represent pent up buy pressure should the stock move against the shorts position.
My skills and knowledge are aging in this era of electronic trading but some things should remain true.
Side note, I appreciate all of your posts. Peace out!
Brain bleeds vs improvement of patients. The game seens rigged for big pharma
until we file an NDA, no way to know if the game is rigged, or just that the desperation for an alz treatment is high.
right now they are the only game in town
GET IT FILED, Dr. M. This year!
Thanks bigb11.
It was hidden on my mobile, but clearly visible in my browser!
ToeMind
Links seem to be hidden on the mobile IHub app. Go to a browser and log in to IHub to see them.
This is a fair understanding of the 2b/3 data, most here are in far better shape than they thought. Ignore the FUD, logical fallacies and firehoses of falsehood sprinkled into the Anavex narrative.
Link?
Thanks in advance,
ToeMind
Great video Piotr---thanks for all your work !!!!!!!!
Just ask the Gamestop shorters how that worked out. Not that Anavex will see a short squeeze of that magnitude. Even so It would be nice to a squeeze happen.
Newly available preliminary efficacy results of surrogate biomarkers from the ANAVEX®2-73-AD-004 study; allowing initiation of discussions with regulatory agencies for Accelerated Approval Pathway for ANAVEX®2-73 (blarcamesine) in Alzheimer’s disease with convenient oral treatment
Good luck and GOD bless,
Thanks to Piotr Peter work here.
I agree, mm can paint the tape a day or two but when the buy volume increases day three and four and selling drys up look out.
Learn:
They can maximize value by pricing blarcamesine so that it is affordable and profitable. Blarcamesine can be both affordable and profitable because the cost to manufacture a 50 mg blarcamsine pill is much less than $1.00.
PROFIT per year = Profit per pill times 365.25 times the number of people worldwide taking blarcamesine each day
Learn!!!
GOD bless,
Very interesting to watch i deed falconner. These days of “reach arounds” with share trading between the shorts/naked shorts will come to an end with really good news and quick. I tor one believe Dr. Missling has the goods and knows it. He also has a firm grasp on marketing and distribution. In other words he doesnt appear to be one to sit on his hands come approval for Rett Syndrome.
Just taking his lumps maintaining a low key strategy, get the hard work done lining up the ducks and then picking up steam once major milestones are met. True that the investment community/shorts will be given a heads up on NDA filings for Rett Syndrome and other but I think things can heat up pretty quick.
Good luck
Missling and the board have a fiduciary responsibility to maximize shareholder value. Missling should have stuck to commercializing Blarcamesine for rare diseases where Anavex could charge $150-$180K a year and avoided AD and PDD. Years ago, Missling spoke about modeling Anavex after Alexion, which became wildly successful for shareholders on approval of Solaris for paroxysmal nocturnal hemoglobinuria, a rare disease.
I made a ton of money on Alexion and it was Missling’s idea of modeling Anavex after Alexion that got me to invest in AVXL in the first place.
We all might be rich if Missling had followed through with that strategy. Instead, his ego got the best of him and he wasted a lot of time and resources on AD instead of going full tilt on rare diseases. By the way, selling Blarcamesine for pennies a day to a small subset of mild AD patients will preclude Anavex from charging high prices for rare diseases. I don’t care if he changes the dosage form from a pill to a liquid or vice versa.
Missling was right about being another Alexion but he strayed from that vision to the detriment of shareholders.
My hope is he gets approval for Rett and can match or exceed the price of Trofinetide and then get bought out. That would be the next best outcome for shareholders.
Good luck and God has nothing to do with it.
Plus more dilution and many dog and pony shows ;)
My negativity will have no bearing at all on whether Anavex succeeds or fails.
My advice would be to do some soul searching on the value of spreading uncertainty under the guise of presumed expertise.
I'm already a successfully retired biotech investor and have researched and learned much over my years. I wish you the best as an investor.
Yea, the 4th of July is less than a month away.
FIREWORKS VERY SOON.JUST HOLD ON TIGHT LOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOONGS
Excuse me ... frrol, you are sounding like Investor!!
All good advice.
Biotech investing is not for everyone.
A number to watch is Days to Cover.
https://www.nasdaq.com/market-activity/stocks/avxl/short-interest
I've managed risk during a few short squeezes in my day. They are quite exciting.
I've added to your sentence:
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Anavex®Life Sciences Corp. (the “Company”) is a clinical stage biopharmaceutical company engaged in the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including drug candidates to treat Alzheimer’s disease, other central nervous system (“CNS”) diseases, pain and various types of cancer. The Company’s lead compound ANAVEX®2-73 is being developed to treat Alzheimer’s disease, Parkinson’s disease and potentially other central nervous system diseases, including rare diseases, such as Rett syndrome.
Anavex®Life Sciences’ lead drug candidate, ANAVEX®2-73, recently completed successfully a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX®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. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation for Parkinson’s Research has awarded Anavex® a research grant to develop ANAVEX®2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX®2-73 into a Parkinson’s disease clinical trial. ANAVEX®3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions.
The Company is in preparation for ANAVEX®2-73 for a Phase 2/3, placebo-controlled trial in Alzheimer’s disease as well as a Phase 2, placebo-controlled trial in Rett syndrome, for which the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for ANAVEX®2-73 and a Phase 2, placebo-controlled trial in Parkinson’s disease.
Headquartered in New York, Anavex® Life Sciences is an American publicly traded corporation on Nasdaq quoted as AVXL
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