Anavex Life Sciences Corporation (AVXL) Quote

Money dammit!!! All we want is more and more MONEY!! Arent you aware its not about patients getting better or approval just give the hungry market more gratification through profits!!

All sarcasm of course but true unfortunately.

This doesn’t make sense to me. Why, and how, would the CHMP conclude, before the application is completed/accepted, that the substantive results are not good enough? Any perceived deficiencies in the application, it would seem to me, would be procedural/technical as opposed to substantive, no?

Barring some clearly fatal flaw in the trial methodology or the validity of the data, or a fatal error in the statistical analysis, the agency will accept the application and decide based on substance, right?

There was more buying volume than selling today and the last few candles were green also. Yet the stock closed down 6%+. A neat trick but not unusual. I suspect they may be running out of ammo. Not literally. Of course they have more funds, if they choose. I mean they may be getting antsy from a risk-reward standpoint. No guarantees. Such are the whims of the mm-hedge fund traders. Although one of their backdrops is time. So the equation is really “risk-reward-time”. This is why, when they see a presentation with nothing new, and no firm prediction of imminent news, they move the stock down. They think they will get out of the trade later, while they to try to play on investors’ patience.

As the hedgie agents like to say, “kick the can down the road.”

None of this has any bearing on actual substance. It’s a game.

I don’t exclude that no MAA will be filed, but more a question of when. To me it is more likely Anavex could fail to respond satisfactorily to clock stop 1 requests, simply because the P2b/3 results are not good enough once scrutinised by CHMP.

Because he lies.

the Anavex clinical program is very much alive

That is not the belief of the marketplace which has now reduced AVXL's enterprise value by 74% since November 2022. My post was about the market's perception of AVXL's clinical program and the stock price is the reality at hand. If you want to believe AVXL's 2-73 AD and Rett clinical programs were successful and on the verge of regulatory approval, then you be you but that alone will not cause the stock price to recover. Under the best of circumstances, substantial delays are being seen and and additional trials may be required. The reality is that AVXL's stock price is declining daily because of marketplace perception and that's the yardstick that measures returns to shareholders--just the hard facts at hand. As a CPA, I am a numbers guy and I do not get bogged down with hope and wishful thinking. I do agree with you that AVXL's cash position will enable to company's life raft to drift along for quite a while. When I see applications for regulatory approvals moving through the agencies' timelines toward approval in AD and/or Rett's, I'll perk up and gladly recognize that the business fundamentals have improved. Until then, the stock price rules and the negative perception cannot be denied.

These posts are so much more stupid than anything the so called “pumpers” put forth. Oddly (?) nobody ever complains about this. Surely you could come up with something more intelligent? Or are you relying on repitition?

TGD has no strategy and plan to bring this drug to the market, he is just using kick the can strategy. Today's presentation was worst, he kept his eyes closed for so many times and he was keep rocking back and forth, it looks so bad on zoom. Guy is a CEO and MBA from Kellogg, he should know how to talk and convince the audience.

I don't know how you come to your conclusions about the Anavex trials.

1. The AD trial prospects are looking better than ever, given (1) the CHMP go ahead for filing an MAA; and, (2) the draft FDA guidance pretty much obviating the need for an ADL endpoint win, validating Kun Jin's .025 ADAS-Cog/CDR-SB choice.

2. The Rett trial was not a drug fail; it was a trial design fail. Not good, of course, but not at all a repudiation of 2-73's efficacy in this indication.

3. As for schizo, we are dealing with a 3-71 trial.

Whatever your perception of other people's perception, the Anavex clinical program is very much alive, with a solid cash position for the upcoming AD regulatory season.

Perhaps the trial should have been much longer, but better still, make it shorter, give all the drug and observe the larger number of patients on the drug.
Gary

And 93% of those in the trial continued in the "OLE" Open Label Extension. So far no reports that I know of but those 93% are still on the drug. In Time it is the same as an extended trial. They either continue to get better or else they don't. One would think that one of these days we should hear something from the company. I have watched some of those interviews with the parents of some of those young girls. They seem hopeful. Some have stated their child has improved. Less "episodes" some physical things the child wasn't able to do prior to receiving 2-73.

John k9uwa

The end of session questions were excellent. A few notes from them:
- When discussing the brain shrinkage, Missling said they were very excited to see (show) it in the "the full data in the paper, or a presentation, however it will come first." The company may not await formal publication but push to present the paper at a conference after the peer review is completed.
- There was "signal" in pTau data. Though no mention that it was stat-sig. So likely it was not but shows some correlation to amyloid signal.

When someone asked pointedly for Missling to clarify the ADCS-ADL % change, Missling finally states it wasn't stat-sig.

Only, the world's drug agencies will decide a drug's pass or fail. IMO, 2-73 will pass!

When 2029?...plenty of buy opportunities before then...

What if 202?...same

What if next year?....same

No submission this year even if given green light to file...

Sorry for your loss...You will feel much better in the days ahead..

Funny, you only show up on beat-down days for this stock, along with several others.


Perhaps you need to do a time stamp on my posts and look at the share price at that time and then compare.


Check my post from January...calling sub 4.....https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173546029

What is funny is your continued belief there is something here and Chris is holding it tight to his vest.

News for you...The only thing Chris is holding tight is his sphincter and very soon he won't be able to hold it much longer...


Cuss me all you want....Ive been right since August when I first suggested its time to bail.


By the way, how is that mystery rare disease trial doing?

Going to be down day tomorrow. Futures are falling

Yep. They are manipulating it to an inflection point. And they will be laughing over their martinis at Harry’s about the dupes who held for years only to sell at the low right before “Thank you for playing, we have a lovely door prize for you on your way out. You paid for our drinks.”

Thank you!!

As far as a bounce tomorrow...Perhaps, maybe 4.25 and back down next week.

I just don't feel confident getting back in with Chris "running" the show. All he is running...Is the share price into the ground.


There was a lot of hope. Not anymore. I just don't believe a word he says...

I'd like to ask a question. Why does everyone blame Missling for problems with trial design or accomplishment as though he designed them himself. Looking at his background, his expertise is financial in the industry, not the medical side of the house at all. With 4 years of funds available, I would say that he's doing a good job on the financial side of the company. He's okay at presenting the science they've developed, but I doubt if he really developed any of it, or had much to do with trial design.

Ultimately he's the Capt. who's responsible for the ship, but with four years of funding, I believe he has the time to gain approval for their products in multiple indications and from several regulators. In more than one occasion I've seen the approval of products that failed to meet all trial requirements without further trials immediately. In some cases confirming trials were required, but the product could be sold while the confirming trials were being done. On more than one occasion it was the placebo's doing better than anticipated that resulted in the failure. I'm a believer that trials should be run against historical data so all who enter the trials gain the benefits, I suspect if the RETT's trial had been run that way we'd be openly sure of approval. The improvement noted in the placebo side appears to have been caused by observers hoping that they were seeing improvements, it's hard to overcome hope even if it's not real.

Placebo effects are real, and that's a problem, they're real, but they don't continue indefinitely, the drug will. As I understand it, observers who viewed placebo patients as improving over time realized it wasn't being sustained, but that was after the trial concluded. Perhaps the trial should have been much longer, but better still, make it shorter, give all the drug and observe the larger number of patients on the drug.

Gary

If I say it is the contrarian, (short and bad boy) expression of this concept, does it make sense?

Could also say "last ditch effort" of the shorts?

Good explanation. What would be common reasons, if any, that the interested parties would decline participation in the trial?

The difference, last time around the company hadn't released half-ass data.

I am with you on the manipulated part of the market. Forgive my lack of understanding but do not get what you mean by contrarian expression. Please help.

No more BS

SHOW ME NDA
SHOW ME PARTNER
SHOW ME APPROVAL
SHOW ME COMMERCIAL

The pediatric Rett syndrome EXCELLENCE trial using Anavex's blarcamesine was NOT a failure.

Great!!! When is the expected commercialization date when revenues start to pour through the door, Georgie? The FACT is the trial failed to meet multiple prescribed endpoints per the AVXL press release and the stock price declined significantly upon the release of the trial results. But, by all means, you continue to be you--a shameless pumper.

With the amount of corruption in "the market" you must allow for a manipulated contrarian expression.

It's all smoke and mirrors.

I don't really think most companies reveal even a small fraction of the meetings they have with the regulators, so I have no idea who they have, and haven't spoken with. I really don't know if the FDA is the best regulator to begin with on RETT's, in AD they clearly chose Europe because much of the trials were done there. I know the FDA is considered the gold standard, but they're also thought to be in the pocket of the BP's. I don't know that approval elsewhere wouldn't be smarter. As an American I've never liked the way the FDA operated, they have delayed numerous products that were clearly worthy of approval, and every such product that I considered worthy was eventually approved as long as they could afford to go the additional mile demanded by the FDA. Sadly I believe millions of patients lose the benefits they could have received if the FDA had approved, and perhaps removed any doubts with a conformational trial. I think they've gotten a little better, but still aren't the dynamic agency I think they should be.

Gary

Already have sizable position and if we keep on dropping will continue to buy. Same thing I did last time around. Normal is each buy the same dollar amount. As it drops the # of shares increase. One mistake I made for sure. I saw the first posting from Korsinsky and it had Adam listed as their "Biotech Journalist" Same law firm same jerk as last time. I should have SOLD and waited but didn't. In the end it will be all OK. I did post it to I Hub that the lawsuit was ON.

John k9uwa
have been here since 2015. Not likely to be leaving anytime soon.

Anavex replay from Noble Capital Markets Healthcare Conference - April 18 2024

The pediatric Rett syndrome EXCELLENCE trial using Anavex's blarcamesine was NOT a failure.

THAT IS A FACT!!!

Good luck and GOD bless,

the way I'd show what I had is by applying for approval to the regulators. I believe that even in RETT's they have sufficient data to take a shot

My opinion is that AVXL will certainly not proceed with an NDA for Rett approval based on a technical trial failure to meet endpoints without the FDA's encouragement. By the way, has AVXL even requested a meeting with regulators to discuss the EXCELLENCE results? Nearly four months have passed since the top line data was released. Will we see full data by mid-year 2024? It could easily be late 2024, or later, before shareholders see any additional clarity about any path forward in Rett Syndrome.

“If they are committed then I think the medical staff can order whatever meds they want, no?”

As long as they dont delay the trial from those damn covid requirements. They probably still have the i patients walking round with masks.

Ohh just the thought!

Good assessment of the conference Skitahoe. I agree with it and might add that they are not waiting for approval before thinking a out commercialization. I find it in stark contrast of many negative posters here the fact that a company who is so crooked in producing illusionary trials data has spent much of their last 3-4 presentations highlighting the commercialization aspect “ ahead” of approval. He even mentioned utilizing Amazon this time around , which I had envisioned some months ago, as a reliable source for delivery. This drug, its partnership (s), and its access to market is going to revolutionize the way medicine is practiced in the not too distant future.

Along those lines too he is very upbeat about the Fda and their new endpoint acceptance qualification for AD. Couldnt happen at a better time, for a better drug, for a top notch company.

I say pound sand to all those who are looking for tree branches high enough with ropes in their hands. I also had a vision/reflection of a time long ago when another person was trying to share something revolutionary with the world. He also went to another group instead of the first group for acceptance and still, the powers to be were overly concerned about their wealth, status, and power so much so they had Him killed. The more things change the more they stay the same.

Blessings

Tred

there is a very good possibility that AVXL will rally based solely on news that ANVS is successful with their AD and/or PD trial.

I seriously doubt that so we respectfully disagree. It's doubtful that AVXL would participate in any such rally when its lead drug is perceived to have failed in both a AD and a Rett trial. Unless Missling can file an MAA in Europe and have it advance toward regulatory approval, it will be left with 2-73 in a small Phase II schizophrenia trial and Rett in total limbo.

I feel bad for all the people that Clint has strung along for years and lied to.

We don't even know if the promised journal article has been accepted anywhere.

The April 2024 Corporate Presentation states "Data from the blarcamesine Phase 2b/3 ANAVEX®2-73-AD-004 trial to be published in an upcoming peer-reviewed journal". To me, that certainly implies that an article has been accepted. I suppose a more cynical view is that the statement only expresses AVXL's intentions. The SEC filings don't address a journal article at all so far as I remember.

Misleading has con his WGT crowd, now he is telling AD trial didn't meet all end points. What a crook! he sold his last options at $5.11, he knew this will keep sliding down to penny land. Sketchy company with sketchy employees; ceo, accountant, model and IR. WGT still believe in this, keep providing example of another scam company NWBO.

Yes, I agree. Thinking any big drop down into that zone in the coming weeks ,3.00 to 2.00 area might be a quick plunge and sharp bounce back up. The kind of spike that gives traders one hour (or less) to catch it on that day, gotta be watching the market open and stay focused. Catch the falling knives.🗡️ 🎯

Powerwalker, I agree, but the way I'd show what I had is by applying for approval to the regulators. I believe that even in RETT's they have sufficient data to take a shot and potentially they could gain an approval that requires a conformational trial. The development of an NDA is a major issue, but committing to get it done should be a big shot in the arm. I know that these things take many months, not days or weeks, to do, but to be successful they must be done.

Gary

You can also bring up any time frame wanted on Yahoo Finance as well. Select Advance chart. Down on the bottom pick your time period wanted. If we go the way of the previous drop to $1.56 which I doubt this time around. For sure it won't be as long coming back up as last time around.
John k9uwa

power walker[quote]1) The members of the Board know the plan and the strategy going forward; you nor anyone on this board knows that.
2) The Board members have seen the full results of all the trials. They agree in principle with 1).
3) They are well aware of TGD's short-comings. His management of 1) and 2) over-rides that concern.
4) Tom Skarpelos is not afraid to pull the plug on a floundering CEO (see Missling's predecessor, Cameron Durrant). He is still in Dr. Missling's corner.
5) Naysayers' success of scaring posters to sell 10K, 50K or 100K over a week's time, is a win for lower prices and its benefactors and indicates a drug's failure. Only, the world's drug agencies will decide a drug's pass or fail. IMO, 2-73 will pass![/quote]

Excellent post. Thank you , I needed that on this darker then normal day.

If your S. Korean connections have lost
peanuts since $12 has your haircut been less painful?
At least there is the equity in Huntington Harbor.

Quote: "It doesn't take a rocket scientist to know that AVXL's stock price will continue to go lower without a positive fundamental news event."

I respectfully disagree.

As I stated before, there is a very good possibility that AVXL will rally based solely on news that ANVS is successful with their AD and/or PD trial. If you recall, Anavex rallied to $30/share based solely on the success of SAVA's AD results...so we could easily duplicate that scenario if ANVS is successful. (See below for ANVS trial results date)

Clinical Updates

Announced Last Patient Last Visit in the Phase III Study of Buntanetap in Parkinson's Disease (PD)

On December 5, 2023, the Company announced the last patient last visit for its PD Phase III study of buntanetap and reported a substantial level of participation with patients enrolled at record pace. Out of 616 total patients screened, 523 were enrolled and 471 completed the trial across 67 sites (43 in the United States and 24 in the European Union). The Company confirmed screen failure (15%) and drop out (9.9%) rates that were below projections.

Reported Full Enrollment for its Phase II/III Alzheimer's Disease (AD) Trial Exceeding Original Projections

On November 27, 2023, the Company announced full enrollment for its AD Phase II/III study of buntanetap. With over 700 patients screened, a total of 353 patients were enrolled across 54 sites in the United States, well above originally planned 320 patients, exceeding the initial projections. The Phase II/III study was a randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap in patients with mild to moderate AD. Patients received either one of three doses of buntanetap (7.5mg, 15mg, or 30mg) or placebo on top of their standard of care for 12 weeks. The Company recently declared a database lock and updated the timeline for top line efficacy data, now expected in April.

Issued Novel Biomarker Measurements in Plasma of Parkinson's Patients

On November 2, 2023, the Company reported new data of important biomarkers in plasma of PD patients, in addition to previously measured biomarkers in CSF. The data showed a statistically significant drop in the levels of TAR DNA-binding protein 43 (TDP43), one of the neurotoxic proteins which is correlated with impaired axonal transport, inflammation, and nerve cell death. To our knowledge, it is the first time that a drug has reduced TDP43 levels in humans. The data also supports the unique mechanism of action of buntanetap in that it inhibits more than one neurotoxic aggregating protein. Evaluating biomarkers in plasma rather than in CSF is a considerable improvement for patients as well as for the sites conducting the study. Plasma biomarkers allow for monitoring the progression of the disease, while making it easy on both patients and doctors.

Message from Dr. Maria L. Maccecchini

"During the fourth quarter of last year, we witnessed a remarkable momentum in our mission to bring novel therapeutics for neurodegenerative diseases, as both of our clinical trials for Alzheimer's and Parkinson's progressed significantly. In December, we completed the Phase III PD study, and we are currently in the process of meticulously cleaning the data. The AD Phase II/III study was completed in February, and we announced that we cleaned the data to our satisfaction and will release top-line efficacy results in April.


Annovis Announces Publication That Supports Understanding of Buntanetap's Mechanism of Action in Humans

MALVERN, Pa., April 01, 2024 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, today announced the publication of new data from an earlier study supporting buntanetap as a translational inhibitor of amyloid precursor protein (APP) in patients with early Alzheimer's Disease (AD).

Buntanetap is an oral molecule that selectively binds to an iron-responsive element in the mRNA of APP and other neurotoxic proteins and inhibits their translation. Through this mechanism, buntanetap was shown to decrease the production of amyloid beta (AB), a key hallmark in AD. This study, which was finished in 2021, aimed to assess pharmacodynamic effects of buntanetap on the translation of APP mRNA by employing Stable Isotope Labeling Kinetics (SILK). SILK measures the translation, steady state, and degradation of a protein in the cerebrospinal fluid (CSF) and is able to detect subtle protein changes, which cannot be measured in normal CSF sampling. Here, SILK was used to measure the kinetics of APP in early AD patients and to quantify AB40 in CSF.

In this randomized, double-blind, placebo-controlled study, participants received oral buntanetap (1x60, 2x60 and 3x60 mg per day or placebo) up to a 25-day period. At the end of the study, patients were catharized in the lumbar spine for 36 hours to accommodate the total time it takes for APP to be synthesized, processed into AB, and degraded. A total of 15 patients completed the study. Notably, the analysis of adverse events demonstrated no dose-dependent effect of buntanetap compared to placebo, affirming the drug's safety and tolerability. Furthermore, multiparameter modeling of APP kinetics provided additional evidence for dose-dependent lowering of APP production by buntanetap. A model that included the pre-drug lumbar CSF concentration as a covariate showed statistical significance between the placebo and 120, 180 mg per day buntanetap groups, suggesting a drug effect on lowering APP production. In general, buntanetap lowered the rate of translation, the maximum concentration (Cmax), lengthened the Tmax, and decreased the area under the curve (AUC). It is important to note that the results were not statistically significant (other than the difference between placebo and 120 and 180 mg mentioned above) due to a very small number of patients; however, the demonstrated trend fully mirrors the mechanism of action of buntanetap as a translational inhibitor of APP.

About Buntanetap

Buntanetap (formerly known as Posiphen or ANVS401) attacks neurodegeneration by inhibiting the formation of multiple neurotoxic proteins - amyloid beta, tau, alpha synuclein, and TDP43 - thereby improving synaptic transmission, axonal transport and neuroinflammation. Dysregulation of these pathways has been shown to be the cause of nerve cell degeneration and ultimately death. By attacking these pathways, buntanetap has the ability to reverse neurodegeneration in Alzheimer's Disease.

About Annovis Bio, Inc.

Headquartered in Malvern, Pennsylvania, Annovis Bio, Inc. is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer's Disease (AD), Parkinson's Disease (PD), and other chronic neurodegenerative diseases. It is believed to be the only company developing a drug for both AD and PD designed to inhibit more than one neurotoxic protein to restore axonal and synaptic activity. By improving brain function, the company's goal is to treat memory loss and dementia associated with AD as well as body and brain dysfunction associated with PD. For more information on Annovis Bio, please visit the Company's website www.annovisbio.com and follow us on LinkedIn and Twitter.

Gary, thanks for your thoughts on today's presentation.

Maybe, it is time to throw away one of those four years of cash and do a stock buy back of 5 million shares at the 2024 high ($6.94). I know that sounds irresponsible, but if you believe that, within three years, approval will be received for one indication (which indicates approval for other applications, too), then the cash will be there for whatever need there is in the future.

It is time to show the market that Anavex has some cojones and that it believes in its pipeline.

Missling’s public speaking skills are HORRIBLE. Maybe he should have added Public Speaking 101 to his Chemistry coursework at Kellogg’s Corn Flakes University.

How many of your 137 are embarassed
they EVER read your post(s) let alone
claimed they followed you?

Actually, Doc, that is a good one. They know (and might be more worried about) that they can be sued for failure to perform their fiduciary duties, which means their options are worthless, there is no D&O insurance to protect them and they pay out-of-pocket $$$, big ones I might add, for legal defense ... and the friendships turn to hatred (personal experience on that one).

They aren't ready to ditch their friend because ... they know EVERYTHING that we DO NOT!

Blood (Money) is thicker than water (friendship).

Also, if a logic person had read all that the naysayers have written over the last few days and thought those posters were more correct than wrong, then s/he would claim that the BOD is stupid for not firing TGD. This BOD is not stupid ... they know the Anavex plan, 2-73 results and strategy ... and waiting for it to be revealed.

I was in IMGN for about 4 decades, much the same was true much of that time, but it ended well, but frankly not as well as I believe it should have. I do believe the company is advancing toward approvals, it may not be this year, though it still could be, but in time they will come.

Gary

I called the IR number about this a few weeks back and Clift told me he was not at liberty to say.

Nothing positive that I can see at least for the foreseeable future, no.

As I have previously said, I sold 90% of my shares in the high 20s during the irrational run up to $31. I bought a new Mercedes with some of the proceeds and invested the remaining proceeds in Nvidia, where I made another killing. My remaining position in Anavex is too small to make any difference in my life. At this point I’m here mainly for the entertainment value.

I think Anavex is in the early stages of circling the drain. Once in the drain there is no going back. The stock price tells us what we need to know. I’ve previously stated why I say that and I see no need to repeat myself. People can blame the market makers, Adam Feuerstein, or whatever. Suffice to say I have been right about Missling/Anavex all along. All the fumbles, stumbles, goal post moving, changing endpoints, fibbing, etc., are finally catching up with him. You can only get away with so much before the party is over.

Missling has indicated it has been accepted, but of course the time line isn't working.

I would consider this a more critical matter if CHMP hadn't already cleared an MAA.