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I'm commenting on the papers listed the link.
Research costs money, and we all know $AVXL has an untapped S-3 on file.
I would not be surprised in the least to see a financing event upon a price increase. I think it's Cantor's turn to help fill the coffers.
You and Hosai are looking at the separate and ill stated Huey complaint.
The Blum case and their response to the motion dismiss is the one to focus on.
Exactly and after reading the Anavex reply, you can see why so many cases are dismissed due to the plaintiff's failure to meet the required elements to move forward. Also, both sides have lists of case law to back up their stances but this is not a "trial on the papers", this is about meeting thresholds. My guess is for full dismissal.
There is a reason why no new trial has been started, company preserving capital for eventual settlement of class action. Hope BOD makes wise decision and get rid of blabbering buffoon, otherwise this company had no future.
Misleading attending but not presenting? Which is good, otherwise stock would have tanked. Guy never misses any dog and pony show.
So far taking long for release of trial outcomes has meant a need for creativity results presentation, sometimes of the kind that can end in class action complaints.
Joe Rogan (and most others) understand it well...
We're being lied to on a daily basis.
“What the hell did Dr. missing do to piss off the wrong entity?”
He’s an incompetent boob who has enriched himself at shareholders’ expense, that’s what the hell he did.
When do we get the OLE top line data? Has been 3 months since it ended...should come out soon, right?
There was one person looking to put limits on executive compensation - in the event of a buyout, I think. The person that put it forward was passionate but not rude, I think. Their proposal was voted down by a large margin but it was a mechanical not emotional outcome (or that is the way I read it.)
There were people who wanted the stock price to be higher (who doesn't?) There was a physician at the table offering his opinions. There were questions about what happens next with Rett. There were questions about the 3-71 trial, There were questions about the pipeline.
No one, that I recall, was aggressive or directly critical of Christopher Missling. Did someone here report differently?
So far the motion to dismiss has not been granted. Also note there are now two separate cases and imo the Bloom case and that response to the motion to dismiss is the one we now wait to see the outcome of. Forget the Huey case.
There is no doubt, as I have pointed out way before this case, that AUC was a nonsense attempt to rescue the outcome of the AVATAR trial, which to date Missling has refused to reveal the Baseline to EOT RSBQ result with CGI-I anchored or not. From the data we have seen it is clear why Missling is not keen on showing that originally published primary outcome measure.
Any near term valuable future for $AVXL rest on the AD MAA being filed and approved. Without that plus a potential class action settlement is a disaster at least for current investors. Good to know that we have an 83% chance approval, right!
With the Bloom case the 40/60 chance of settlement vs. dismissal is at least as valid as your claimed 83% chance of EMA approval for AD.
We have no choice but to wait for the outcome of both and I hope Bloom lands in the 60% bucket and MAA approval in the 83% bucket.
No, I suspect this complaint won't survive.
You are giving too much credence to the filing of a complaint. Anyone can file a complaint, even if there is no case. A complaint has to survive a motion to dismiss or a motion for summary judgment before it has any meaning.
Your imagination seems fully functional albeit a little biased.
Missling was a lawsuit waiting to happen. The Board made some good moves, though a little late.
I can't imagine judges being overly keen on allowing people to sue whenever share prices don't go the way they wanted and and they choose to sell at a loss. However it will make a investing a lot more easy if this is allowable from now on as can limit the downside for us all.
This is Anavex' lawyers latest reply to the motion - https://storage.courtlistener.com/recap/gov.uscourts.nysd.617466/gov.uscourts.nysd.617466.40.0.pdf
Having worked for many years dealing with and working for bureaucracies there are many hard working competent people as well as many lazy incompetents. It creates inefficiencies and lots of fat and waste.
Having read through the "MEMORANDUM OF LAW in Opposition re: 36 MOTION to Dismiss" this morning, I am afraid that the Security Class Case does have merit and will continued.
As I have posted over the last few years, since the AVATAR readout, the RSBQ-AUC used to 'rescue' the failed trial is complete nonsense. I have done my best to explain why - and based on very simple fact that a biotech investor should/must understand. I have also shown in the written notes from Anavex slides that the FDA Guidance referred to is on anchoring a caregiver subjective score to a Pro-score e.g. RSBQ by caregiver scores anchored to the physician observed CGI-I score, as ultimately used in the also failed EXCELLENCE trial.
Hopefully Anavex does have sufficient D&O insurance, as I suspect an early settlement will be the appropriate outcome. After that I would think Missling will no longer be allowed to continue presenting the company's clinical trial communications. I could see him as a good CFO.
This case is now firmly in the 40% bucket of those that settle. Hopefully the EMA MAA submission for AD, if and when it is filed, will land in the 83% bucket to balance out this mess and get Anavex under management that can do a better job of leading the SIGMARCEPTER platform potential towards possible approvals.
I don't think Anavex, as some claim, is a deliberate scam just poorly managed.
It certainly doesn't hurt that the big boys have inadvertently paved the yellow brick road for Anavex...
https://medicalxpress.com/news/2024-09-revolution-mirage-controversy-alzheimer-drugs.html
Swinging by to see what terrible investors are still here…I’m not suprised by who still is 😳
‘Faith is not an investment strategy’
It’s ‘ALL’ a scam. If your new here save your money AGTFO.
You are correct and I thought this article would be interesting to you as it's from the entities that actually insure Directors and Officers.
https://www.dandodiary.com/2022/07/articles/securities-litigation/guest-post-analysis-of-biotech-securities-class-action-motion-to-dismiss-results-2005-2022/
It is amazing to me how much time and energy is wasted to try and destroy this company by fudster’s, hedge funds, MM, Jim Cramer. BP, On and on. What the hell did Dr. missing do to piss off the wrong entity? Clearly they will not give up to kill AVXl. Please lord let this hit $30 per share so we can get the hell out.
Keep in mind that lawsuit is bogus and not the result of any actionable misconduct by Anavex.
I think Misleading has some kind of childhood trauma that haunt him and prevents him from accepting failure. Otherwise, why would he come up with so many ridiculous post-hoc endpoints? First, he starts with tiny trials, which are 99.999% bound to fail, then he tries to find signals within the small data set and comes up with absurd AUC or OR endpoints and claims trial met all endpoints, but never files NDA.
I hope this class action goes to trial. He won’t lose anything personally, but at least it might wake up the BOD and push them to get rid of him.
Misleading has dug bigger hole for himself with his AUC end points. What a clown. First, he claimed AUC was an FDA recommendation, but after the lawsuit, he said he never discussed AVATAR endpoints with the FDA. He’s the king of flip-flopping, always coming up with nonsense justifications. The BOD needs to wake up, fire him, and bring in someone who can actually deliver.
The RSBQ AUC, the ADL OR, the GABA and glutamate claims. It's good that Jin is now handling endpoint and results reporting. Missling was getting over his skis and ended up even attracting a lawsuit. The BOD took some smart actions.
Criminal syndicate is alive and well.
The PDF of MEMORANDUM OF LAW in Opposition re: 36 MOTION to Dismiss . . Document filed by Quintessa Huey..(Apton, Adam) (Entered: 09/13/2024) is now available from Courtlistener.
The argument against the motion to dismiss is now focusing in on the Rett primary endpoint change to the nonsense RSBQ-AUC vs. the protocol RSBQ-CGI baseline to EOT score that Anavex continue to withhold.
Unfortunately this securities class action case is not dead yet.
Expect more BS lies by next Thursday which will scare potential investors away thinking this board/stock looks like a scam.
Only off by 3 million shares.
This week's price action offers some clues.
We saw a bullish looking support hold at 5.30, then climb to hit resistance around 5.90. Now a pullback testing 5.50/5.45, and finishing the week around the Moving average magnet 5.55 .5.60 is a step to watch. The 5.50 area has a chance to become a support base, as does 5.30 and 5.40. The shoulder zones 5.30 and 5.60 area to watch. It's broken when it falls to 5.00, but recovery to 5.80 area regains the bullish momentum...all centered around that moving average at 5.50. And it fits the larger wave pattern picture, with a bottom zone at 3.50 to a wave peak around 7.50, you've got the 50% Fib and moving avg. target at 5.50...all looking just technically right.... and in a waiting phase like 2024, long term charts want to develop over time, smaller range patterns, like peaking again at 7.50, or bleeding down to 5.00 again...maybe 4.65 as a target bargain in the coming weeks... 🤔 🎱 , but some measured controls of the price, in a range for now, with several months to go... I'm still neutral, looking to see how far down the bleeding game can take the price to best bargains. I'll say 4.50 is still in play. Unless there is big news coming soon.
It's been three good years since we've seen any kind of real positive stock price action so I'm going to stick with what I've said the whole time the only three things that's going to bring this up is approval partnership or a buyout everything else is nothing but word salads and there's been plenty of them
Indeed there was a lot of undue influence. Much of which came from the AD advocacy groups. The generous explanation is that they wanted something for AD patients even if it was minimally effective, it was better than nothing. The less generous explanation is those advocacy groups were supported by large donations from the companies trying to get their drugs approved so it was in the self interest of the advocacy groups to advocate for approval.
All in all, I see that as a political decision to satisfy the advocacy groups. The FDA had to know that the costs and minimal benefits would not see the drug be widely used. In fact the first one was withdrawn from the market place due to non acceptance in the market.
So the FDA threw a bone to the AD advocacy groups that had no meat on on it.
Isn't it weird how those big MOC trades are priced near the VWAP.
Then we have a bunch of whiners here who don't believe in wholly on what they post!
Somehow you seem to be focused on one poster that has an unrelenting positive view of Anavex. And yet you don't seem to have that same focus on the poster that has an unrelenting negative view of Anavex. Why is that?
It's like you think that one poster can actually make a difference on what the stock does or can have a significant influence on other posters.
I suggest you check your assumptions.
There was also genetic data to be sent to labs and evaluated. Gene expression and gene variants were also part of the other measures. Those things take time both to get back from the labs and to evaluate.
Most trials just use the standard measures, that are scale data, which is easily processed.
The bashers, FUDsters and shorters painted the tape today for AVXL stock just prior to the close of trading, today!!!
GOD bless,
Yes it is.
The decision is based on the belief that Anavex will ultimately succeed. How ever it also provides enough time for an exit strategy if things look bad during that time frame. It will be at a loss of course, but as you have posted, sometime you make money and some times you lose money.
I still have the fundamental evaluation that Anavex has multiple shots on goal and it only needs to score once for there to be money to be made.
Some might call that WGT. Others might call that enlightened optimism. Either way, I have allocated money based on my evaluations of the situation.
All of my investments discussed on this board are out of my high risk trading account. If that account gets wiped completely out it would be really annoying. It would not affect my life style at all. If I make money in this account, it is all discretionary spending money.
Good luck to all that follow Anavex.
“ there can be several unsatisfactory explanations for it.”
Beautiful!! That’s what’s needed for one of the highest profile decisions at the FDA in recent history.
Wow! Did you put correct year? Always use TGD calendar....his calendar start with 'soon' and ends with 'very soon'.
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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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