nidan7500
6 hours ago
Thanks...I THINK?
Is this a preview of a soon to be released work showing AVXL new data?
Great if true...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...
Robinsold
6 hours ago
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...
Investor2014
13 hours ago
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.