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10 years after published paper release
Quote: "Once the 2-73 MOA is proven they will all take notice."
That day is coming - within the next 5 months - when the NDA is filed and the peer-reviewed journal is announced. THAT will not only confirm the MOA of A2-73, but it will send a message throughout the biotech sector that Anavex is for real.
And make no mistake, BP will be knocking on our door wanting to partner in every which way they can. Why? Because we have just filed our NDA...and everyone knows that that is the final step before approval is granted.
The clock starts ticking in everyone's head...and they start asking themselves: Does Anavex really have enough data to be approved for an NDA? Oh wait! I better read that peer-reviewed article again. Holy smoke. I had no idea that A2-73 was this effective in preventing brain atrophy...and look at all of the benefits of autophagy! This drug is incredible. I better buy some stock before it breaks the $100 mark.
Now that I've bought some stock for me, I better call my family and friends...because if their NDA is approved, the stock could easily break $300/share.
Of course, this is just my opinion but I'm betting that this scenario plays out exactly as I've said.
Cheers!
Very good data from the adult Rett trial?
No that Avatar Rett trial should have told Anavex to not go with a 2:1 dose:placebo design!
LOL!!!
So if Missling had said first half of 2024 you would have marginal excuse to gripe...
But "mid-2024" is a generalized term that could apply to months or weeks either side of the date that marks "mid-2027"
What is the middle day of the year 2024?
This is the latest accepted revision, reviewed on 2 July 2024. July 2 is the 183rd day of the year (184th in leap years) in the Gregorian calendar; 182 days remain until the end of the year. In common years, this date marks the midpoint of the year, as 182 days both proceed and follow it in the Gregorian calendar.
July 2 - Wikipedia
Wikipedia
https://en.wikipedia.org › wiki › July_2
That outcome was unexpected due to the very good data from the Adult Rett trials and the expectation that treating Rett patients earlier in the disease process would yield even better results.
Wasn't the improvement in RSBQ better than that of Trofinetide P3?
I think that setting a pretty low bar,holy cow
Exactly why was that outcome unexpected?
“If the Rett trial had not had the unexpected outcome Anavex would be $40+ stock and Missling would be viewed as a great CEO.”
That is except of course from the perspective of biotech ‘investors’ operating with an irrational 99% chance of approval based that Rett trial.
I for one has yet to see Missling take qualified action that will see $AVXL be a $40+ stock. Talk doesn’t do it for this investor, but who knows maybe it will change if we wait long enough such as for additional well designed confirmatory trials.
But 99% chance, no not even then.
It's a holiday week. What did you expect for trading?
XBI was down and Anavex was up. That is against the usual trading pattern.
XBI -1.87% AVXL +0.5%
AH AVXL +5.52% For whatever that's worth.
Early on, Merck, Lundbeck and Takeda were willing to join Anavex in the Consortium as each perceive some value in 2-73..
Those three companies (and others in the Consortium) will be rewarded for their foresight in the long run.
Let me know when wall street and most investors here believe or trust missling
Check ANVS CEO; she is open and straightforward in her communication to shareholders, unlike the clown who said mid-2024. Now we are in the second half of 2024, but still no PR on the Rett trial and AD RNA data.
Unfortunately it doesn’t look like Missling is going anywhere (except on vacation).
Biogen looked at 2-73 for MS and that was years ago before much of the positive data was developed.
All of the major BPs are watching Anavex to see what finally happens with the MAA and NDA. That will have a direct bearing on AD research going forward and as such their drug pipelines.
Whether they want to buy out Anavex, partner with Anavex, or continue to pursue their chosen research/drug development direction will be an individual BP choice.
Once the 2-73 MOA is proven they will all take notice.
If the Rett trial had not had the unexpected outcome Anavex would be $40+ stock and Missling would be viewed as a great CEO.
FDA Roundup: July 2, 2024
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
Today, the FDA approved Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease.
“Alzheimer's disease is a devastating disease for the person diagnosed and their loved ones,” said Teresa Buracchio, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “The trial data demonstrated, convincingly, that Kisunla reduces the rate of cognitive and functional decline in patients in the mild cognitive impairment and mild dementia stages of Alzheimer’s disease. Today’s approval is evidence of the FDA’s commitment to helping more safe and effective drugs to treat Alzheimer’s disease become available.
Steady--" Is he perfect? No."--appreciate your comments--curious-when did you buy your first shares of Anavex ????
Xena, I believe you know about NWBO's suit for spoofing against 7 MM's. If this ever reaches court I feel certain it will show that the MM's are helping the shorts and hedge funds to keep the share price down. Some believe the naked short position in NWBO could exceed 1 billion shares. I don't believe this will ever go to court as the MM's won't want the way they do business to be exposed, I'd not be surprised to see it settle shortly after the judge dismisses their last MTD motion, which could come any day.
I would hate to see more companies have to pursue such actions, but if the regulators just keep ignoring naked shorting it may come down to that.
Gary
You keep claiming Missling is a failed CEO and pushing that story day in and day out.
I, for one, disagree with you on that. Is he perfect? No. Has he managed the company finances well? Very well.
If the Rett trial had not had the unexpected outcome Anavex would be $40+ stock and Missling would be viewed as a great CEO.
And as far as missing out on a bull market, not me. I am quite happy with the position I have amassed in Anavex over the years. It is my high risk money so it in the unlikely event that Anavex fails my life style will not change a bit. If it succeeds my life style will change.
Missling has Anavex well positioned with no debt, multiple drugs in the pipeline and the approval process started for one of the biggest diseases in the CNS space.
So keep pounding on that drum. It isn't going to make a lick of difference. Missling has gotten Anavex to the point that trial results are all that matter.
Wish I were qualified to comment on this PR:
FDA and Endpoint Clarification: Recent questions regarding the primary and secondary endpoints in MDS-UPDRS scores warrants additional explanation. Initially, Annovis chose MDS-UPDRS Part II+III as the primary endpoint. However, based on FDA feedback, MDS-UPDRS Part II alone was deemed more appropriate for reflecting clinically relevant changes (Goetz et al., 2023). Consequently, we adjusted our primary endpoint to MDS-UPDRS Part II, with MDS-UPDRS Part III as a key secondary endpoint. Our results met both primary and secondary endpoints in the specified subgroups.
Something must've leaked because they had almost 40 Million shares traded with an average ~$9.00/share = $360M (That's almost half a billion dollars)
That's a lot of money trading hands for not announcing any p values.
Another riveting day of trading in Anavex—up 2 cents. It sure doesn’t feel like we’re on the cusp of anything—other than falling off a cliff.
Wouldn’t it be wonderful if the BOD decided, in recognition of Independence Day, to declare its independence from DM as CEO of Anavex.
One can only hope.
It is obvious they don’t like Missling and his antics.—can’t say I blame them!
Nope nothing, my original comment I retracted, to triple check.
Nada.
Maybe investor knows what's going on with such abnormalities??
Wolf, I read this AM and did not see any "p" values. That is why I was not surprised ANVS was down early. Non-event, it seemed.
WS and MM's must have pushed it for new financing coming.
Did you see a "p" value?
Lmao, imagine AVXL.
Announces that PR with no p values lol
What a movie this is.
RWE-RWD.works every time.....(Buntanetap showed dose-dependent and statistically significant improvements in cognition in the overall enrolled PD population. Parkinson’s patients with substantial cognitive decline exhibited a very pronounced improvement.
Even the FDA understands and is OK w/that kind of old time hard core evidence-proof.
NO MORE MAYBE_PROBABLY_SOMEDAY. FIGURE IT OUT.
Things that make you go hmmmm!
Nice, George. This post will spur an emergency strategy meeting amongst the Fudsters. Keep up the good work.
AVXL should move up today and tomorrow in conjunction with ANVS.
Good luck and GOD bless,
Apparently the CABAL & MMs are letting ANVS run a bit.
I guess we’re the only company in the CNS space that gets no love from the MMs.
Do you think the people over at anvs are happy with Maria running the show seems to be just a little bit better than misleading here
So then why are you in the stock market? There are other ways to invest, like Treasury bills, commodities, or real estate.
FYI:
$AVXL is holding above 50 day but still below 200 day
$ANVS broke both the 50 day and 200 day.....today!!!
Woulda, Shoulda, Coulda
Maria Macchecchini is one hell of a CEO....straightforward and direct to her shareholders, I like that! Even when the news is bad or good.
Does the "short crew" dare to hit the stock tomorrow on the very early close (I think the market closes early....1pm and closed for the 4th....???? Also, the premium early this morning was only around $1.60 ANVS over AVXL, then jumped way up!
Hadn't read Kevin's comment before I posted last post. Both of us have like minds.
John k9uwa
"No surprise: FDA approves donanemab" Now the patients have a choice of which Brain Bleed Med they want to try. NOT. Read someplace that in Calif it was required to get TWO DOC's to prescribe a MAB. Your 100% correct The Bar is set VERY LOW!!
John k9uwa
Now patients will have a choice in which drug they want to use to cause brain ARIA and atrophy....
No surprise: FDA approves donanemab, Eli Lilly’s treatment for early Alzheimer’s disease. The good news is that the bar is set rather low...
Thanks Guzzi I bought some ANVS this morning shortly after the open. Sold it for +105%. Should have bought more.
Oh Well made for a nice day's gain.
John k9uwa
Sigma-1 receptor (S1R) is a unique multi-tasking protein……..
hmmm……..A2-37 might have multi-side effects: Good ones. : )
Xena.....what a service to Anavex holders....it highlights that the stockmarket is not solely the realm of the country's ownership in public businesses, but a mechanism for shady elements to separate the public from their hard earned money. Just where is the SEC and the Justice Department in insuring honesty at the highest levels of our national financial institutions!
I have represented some very dangerous people. But the worst crooks of all are the kind that will do anything for money. Scammers, hustlers, sociopaths, nuts, and very strange people, bizarre people.
You didn't finish your sentence. "The science is real (what?)...sh!tty, unproven, overhyped? Good, great, earth-shattering, miraculous?
Plex...my supposition is that our drug would have to be approved before prescribed prophylactically!!!!!
Not only have we not released full PDD (3 years overdue), but we haven’t even started the next PD trial.
Still haven’t released full ALZ data, not revealed the “top secret” CNS condition we are also trying to address, and just seem to be coasting along while Annovis is actually making progress.
Ten years and we continue to reward Missling for a job poorly done.
ANVS is almost 100% up, and this POS still in $4, soon and very soon.
Kind of surprised that $AVXL is holding up OK with the $ANVS presentation tonight at 4:30pm and today's PR which seemed favorable prior to that....BTW, they are touching the 50 day resistance on $ANVS....we are staying above it, so far!
“If you don't think that Biogen/Eisai joint venture won't take a run at us for license or buyout you are nuts.”
If you think that Biogen/Eisai joint venture will take a run at us for license or buyout you are nuts.
Biogen/Eisai are committed to the amyloid hypothesis and are putting many millions of dollars and hundreds of scientists into the process. They are not going to suddenly throw it all overboard for SR-1. It’s simply not in the cards. Besides, Biogen already got a good look at Blarcamesine and passed.
Enjoy your pre-holiday fantasy.
The article has nothing to do with Missling - it is about the mechanics of a broken system.
While “long” sales mean the seller owns the stock, short sales can be either “covered” or “naked”. A covered short means that the short seller has already “borrowed” or has located or arranged to borrow the shares when the short sale is made. Whereas, a naked short means the short seller is selling shares it doesn’t own and has made no arrangements to buy. The seller cannot cover or “settle” in this instance, which means they are selling “ghost” or “phantom” shares that simply do not exist without their action.
When you have the ability to sell an unlimited number of non-existent phantom shares in a publicly-traded company, you then have the power to destroy and manipulate the share price at your own will.
And big banks and financial institutions are turning a blind eye to some of the accounts that routinely participate in these illegal transactions because of the large fees they collect from them. These institutions are actively facilitating the destruction of shareholder value in return for short term windfalls in the form of trading fees. They are a major part of the problem and are complicit in aiding these accounts to create counterfeit shares.
The funds behind this are hyper sophisticated and know all the rules and tricks needed to exploit the regulators to buy themselves time to cover their short positions. According to multiple accounts from traders, lawyers, and businesses who have become victims of the worst of the worst in this game, short-sellers sometimes manage to stay naked for months on end, in clear violation of even the most relaxed securities laws.
The short-sellers and funds who participate in this manipulation almost always finance undisclosed “short reports” which they research & prepare in advance, before paying well-known short-selling groups to publish and market their reports (often without any form of disclosure) to broad audiences in order to further push the stock down artificially. There’s no doubt that these reports are intended to create maximum fear amongst retail investors and to push them to sell their shares as quickly as possible.
That is market manipulation. Plain and simple.
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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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