LOS ANGELES, CA / ACCESSWIRE / October 30, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Brainstorm Cell Therapeutics Inc. ("BrainStorm" or "the Company") (NASDAQ:BCLI) for violations of the securities laws.
The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. BrainStorm is the subject of an FDA briefing document issued on September 27, 2023, regarding its biologics license application ("BLA"). The FDA stated, "On initial receipt of the BLA, FDA determined that the submission was scientifically incomplete to demonstrate substantial evidence of effectiveness, and that the manufacturing information was grossly deficient to ensure adequate product quality. Examples of critical information not provided in the BLA submission include missing or inadequate control of materials, validation of methods missing or incomplete, lack of data demonstrating manufacturing consistency, control strategy for prefilled syringe not provided, inadequate manufacturing and testing facility information, and facilities not ready for inspection." The briefing document continued, "in addition to the above clinical and statistical concerns, the review team has substantial concerns about product manufacturing. Those issues have yet to be resolved."
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The class in this case has not yet been certified, and until certification occurs, you are not represented by an attorney. If you choose to take no action, you can remain an absent class member.
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CONTACT:
The Schall Law Firm
Brian Schall, Esq.
www.schallfirm.com
Office: 310-301-3335
[email protected]
SOURCE: The Schall Law Firm