Anavex Life Sciences Corporation (AVXL) Quote

10/31 CTAD Late Breaking Communications:

9:00am LB9 - Phase IIb/III Trial of Blarcamesine in Early Alzheimer Disease Demonstrates Pre-specified Clinical Efficacy Through Upstream SIGMAR1 Activation
Marwan Sabbagh 1 , Juan-Carlos Lopez-Talavera 2 , Kun Jin 2 , William Chezem 2 , Missling Christopher 2 1 Barrow Neurological Institute - Phoenix (United States), 2 Anavex - New York (United States)

https://www.ctad-alzheimer.com/.../ProgramPrel_CTAD2024...

I thought I did say the pleading standards are far from met. It is also not clear that an event study will support damages for the chosen class period.

Yep, I'm a fool. And I know a fool and his money are soon parted.

But u stay !!!
Nmmmmm??)

Just another schitty day. It will be a schitty week and another schitty month. It NEVER changes.

One thing for sure about his negative FUD based angle is that he has yet to address the fundamental legal reason the the case will be dismissed.

Maybe it's different in Denmark, but regardless, his appeals to authority arguments based on his own "authority" is hogwash.

I don't claim to have any legal "authority" but I do have 30 years of managing high risk portfolios which often involve biotechs and my experience mirrors the factual data that cases like this are dismissed.

Not entirely correct. A motion to dismiss for not stating a valid claim must be filed immediately.

Question for you, if BP starts presenting alternative drug approaches to the FDA does that mean the 70% funding is no longer corrupt?


When BP quits following science that shows absolutely no efficacy, siloing researchers, and influencing regulators to move their drugs through rapidly then perhaps the corruption will start to subside. Follow the science.

Excellent top level leadership thinking tredenwater2...thanks again...Look, as an example, at how many articles are coming out with headlines similiar to “Is it time to look past Amyloid?” etc. Imo its a long, slow, and tortuous road for the FDA to shoot off all the toes on one of their feet. With 70%+ of funding supporting them from BP they need time to “pivot” and imo allow BP to get ahead of the new train (invest in) of therapies coming out.

You’ve repeatedly and emphatically said HUGE NEWS this Thursday, September 26. Now you’re saying this week. Why the change?

Thankfully -
He's not an American lawyer
Correct!

See bits in bold.

Given in the Blum and Huey complaint and then consolidated complaint are not doing a good job of:
A PSLRA plaintiff must allege facts demonstrating the existence of the following elements to be entitled to discovery: “(1) a material misrepresentation (or omission), (2) scienter, i.e., a wrongful state of mind, (3) a connection with the purchase or sale of a security, (4) reliance, often referred to in cases involving public securities markets (fraud-on-the-market cases) as ‘transaction causation,’ (5) economic loss, and (6) ‘loss causation,’ i.e., a causal connection between the material misrepresentation and the loss.” Dura Pharm., Inc. v. Broudo, 544 U.S. 336 (2005) (internal citations omitted and emphasis removed). For allegations regarding material misrepresentations or omissions, the plaintiff must “specify each statement alleged to have been misleading, the reason… why the statement is misleading” and all facts on which any belief was formed (assuming allegations were based on information and belief). 15 U.S.C.A. § 78u-4. And for the scienter component, the plaintiff must particularly allege the “facts giving rise to a strong inference that the defendant acted with the required state of mind.” Id. The scienter allegations must be “cogent” and “compelling” “in light of other explanations.” Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308 (2007).
And that a motion to dismiss has been filed:
Discovery is automatically stayed in PSLRA cases unless, and until, the plaintiff alleges the requisite facts to satisfy the PSLRA’s heightened pleading standard. See In re Equifax Inc. Sec. Litig., 2018 WL 3023278 (N.D. Ga. June 18, 2018). The stay is mandated by Congressional statute. 15 U.S.C.A. § 78u-4 (“All discovery and other proceedings shall be stayed during the pendency of any motion to dismiss…”). However, an exception to the discovery stay exists when a party demonstrates discovery is necessary to preserve evidence or to prevent undue prejudice. Id. Undue prejudice occurs when (1) the plaintiffs would be unable to make informed decisions about their litigation strategy due to a rapidly shifting landscape because they are the only major interested party without documents forming the core of their proceedings, In re Bank of Am. Corp. Sec., Derivative, & Employment Ret. Income Sec. Act (ERISA) Litig., 2009 WL 4796169 (S.D.N.Y. Nov. 16, 2009), or (2) the plaintiff lacks access to documents that were previously produced in other lawsuits or to the government. New York State Teachers’ Ret. Sys. v. Gen. Motors Co., 2015 WL 1565462 (E.D. Mich. Apr. 8, 2015). The facts giving rise to both scenarios generally arise infrequently. Therefore, PSLRA defendants usually should not fear engaging in expensive discovery until the plaintiffs satisfy the PSLRA’s heightened pleading standard.
It is unlikely there will be discovery unless the motion to dismiss in not granted. There could have been discovery before the motion to dismiss, if only plaintiffs had a clue and fulfilled pleading standards, for example to get sight of the SAP and establish what guidance or not that Anavex may have received from regulators versus what Missling has claimed or intimated.

Plaintiffs have not described the AUC change of endpoint trick well and have little concrete to support it without discovery.

He's not an American lawyer, but he thinks he knows the Federal Rules of Civil Procedure.

Discovery can also be granted at any time before a motion to dismiss, which is why discovery can be stayed when a motion to dismiss is filed.

A motion to dismiss can be filed at any point in a case. In this case it was filed at the beginning before any discovery was ordered. Because of the security law, that action stayed any possible discovery until the motion to dismiss has gone through the response and reply process.

Yes and it makes sense that discovery can be in progress before a motion to dismiss, say to have sight of the SAP or the said guidance on AUC etc.

Once a motion to dismiss is filed, plaintiff could then have a better basis to oppose the motion to dismiss.

We don’t seem to have that situation and can hope for dismissal given the pretty poor pleading standard.

For example, in federal securities fraud cases, the Private Securities Litigation Reform Act provides that discovery is automatically stayed (except in rare instances) pending a decision on the motion. This is a very powerful weapon for defendants. Once the defendant files the motion to dismiss, there is no discovery until the Court decides to grant or deny the motion.
https://uslawessentials.com/what-happens-after-motion-dismiss-filed/#google_vignette

I should say that since discovery does not appear to have been granted prior to the motion to dismiss the point is moot is this case.

We shall see if the case survives the motion to dismiss, which we can hope it doesn’t.

Nope discovery often happens and obviously so before a motion to dismiss. In fact a motion to dismiss is generally stayed for discovery to complete.

I hope you can see the logic in that, but don’t expect it.

Must have LTB & friends way outdoing BSIG with massive load of dry powder.

Definitely irrational and definitely a day to sell $AVXL 😀👏🙏👌

For one thing you don't know what your talking about. Amazon pill pack is huge, meds are delivered presorted.

https://www.pillpack.com/

Finally, Misleading getting fired ....that is a great news.

The FDA doesn't tell BP what to research. The FDA can only act on the drugs presented to it.
Question for you, if BP starts presenting alternative drug approaches to the FDA does that mean the 70% funding is no longer corrupt?

Expect HUGE NEWS WITHIN THIS WEEK regarding Anavex Life Sciences, AVXL.

Good luck and GOD bless,

117 million shares traded in one day out of the blue on, no news." Plus they manipulate "--show us the proof of manipulation !!!!!!

Discovery won't commence until the motion to dismiss is ruled upon. If the motion to dismiss is granted there will be no discovery.

The only one being fooled is you if you think one poster on a minor message board has any effect on the share price of Anavex.

Amazon Pharmacy ships. My prescription refills come reliably and at a competitive price.

I guess the longer we wait the sooner the OLE results will be released.

And yet those of us who are rightly critical of Missling get labeled as FUDsters, paid bashers or whatever.

For some, the truth is just too hard to face and admitting the possibility of being wrong is too threatening to their fragile egos.

TGD is always eager to showcase his creativity; delay is because he is unsure about which endpoints and statistics to use. Lately, he has been busy with his EMA filing, having to sign millions of pages, while also attending countless dog-and-pony shows in New York.

That is not a concern in this case: there is only one group (all get the drug) and there are very basic measures. Anavex will do fine with this release. I hope they come out with it soon - the trial ended in mid-June and more than 3 months have passed now.

BIOCH--" are frustrated that our CEO is a buffoon who can’t get anything done right or on time"----spot on correct !!!!!!!! Eff'n shame !!!!!

Now would that be great news this week that's even greater than the great news we got last week or the 30 weeks prior to that that kind of great news or real great news

Ok, thanks. Nice rebuttal. I am letting the Fudsters get the best of me sometimes. It is hard to be patient with all this.

408 by 10/15
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There is no evidence at all that anyone here is trying to derail Anavex nor is there any evidence of stock price manipulation in AVXL. There are plenty of people here who want Anavex to have a chance at success and are frustrated that our CEO is a buffoon who can’t get anything done right or on time. But of course conspiracy theories don’t require actual evidence, only conjecture.

"Great leadership is hard to spot until we get an approval, then he will become a"----hopefully true !!!!

However, many here understand your intentions.

tredenwater2We will get there. Just like the EMA is a bit more accepting (although longer process) the FDA will eventually come around and in proper timing, like the recent “pivot” in the reduction on requiring one of the endpoints for early AD.

Great leadership is hard to spot until we get an approval, then he will become a hero to all.

Some of us are beginning to see a different light at the end of this (STAT SIG) tunnel we have all been told to use. Like the man said..."The first step in solving a problem is recognizing that one exists." . The complexity defining each real individual's root cause for AD is likely in some way unique to every patient combination of their Genes soup and what they ate for breakfast. But, I suspect there is some kind of unique genetic human trigger combination event-sequence. Which is why I now only drink Coors. IMO, the FDA went down the STAT SIG path (as causal relation) of problem solving reasoning B/C they ran out of runway.

BTW, I recently (w/in one year) lost my identical twin brother to AD. So I am convinced This shat is real.

It is very clear that very few here understands that using AUC is nonsense with just 3 data sample points. There was only reason for it and that was an attempt at 'fixing' the failed Avatar trial, which was then confirmed by the failed Excellence trial.

We all clearly understand your continued FUDing intentions and the nonsense you continue to spew on this board. It's pathetic!

You totally dismiss the FDA guidance and anchoring aspects applied.

Plaintiff just need to read this board to understand AUC and Misleading's shenanigan. Next law suit will be on Amazon (vitamin) delivery...lol

Nidan while I think the “pass/ fail” criteria is important I also think that the timing of a cepting such a remarkable breakthrough is important too. Look, as an example, at how many articles are coming out with headlines similiar to “Is it time to look past Amyloid?” etc. Imo its a long, slow, and tortuous road for the FDA to shoot off all the toes on one of their feet. With 70%+ of funding supporting them from BP they need time to “pivot” and imo allow BP to get ahead of the new train (invest in) of therapies coming out.

We will get there. Just like the EMA is a bit more accepting (although longer process) the FDA will eventually come around and in proper timing, like the recent “pivot” in the reduction on requiring one of the endpoints for early AD.

Great leadership is hard to spot until we get an approval, then he will become a hero to all.
Cheers

"Open your"---thought so--you can't prove it !!!!!

nidan--" will never fix this as long as we remain unable to accurately - confidently define pass/ fail"--so when to we get real news "of substance"-----been a very long time since we received any !!!!!!!! Kick the can some more !!!!!!.

Open your eyes..👀 Lol..

" Plus they manipulate "--show us the proof of manipulation !!!!!!

Big effort here to try and derail Anavex. Plus they manipulate the stock price. imo

We can hope that the plaintiff lawyers can't think what it is they need to discover.