WHY: NEW YORK, NY - 
(NewMediaWire) - October 01, 2023 - Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf of shareholders of Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) resulting from allegations that Brainstorm Cell may have issued materially misleading business information to the investing public.
WHAT TO DO NEXT: To join the prospective class action, go to https://rosenlegal.com/submit-form/?case_id=19375 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.
WHAT IS THIS ABOUT: On September 27, 2023, the U.S. Food and Drug Administration (“FDA”) issued a briefing document rejecting Brainstorm Cell’s experimental ALS drug. Brainstorm Cell submitted a biologics license application (“BLA”) request in August 2022 and received a refusal to file letter from the FDA in November 2022. Despite this, Brainstorm Cell opted for the regulatory procedure of “filing over protest” and still filed the BLA. The briefing document states, “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.” In addition, the briefing document states, “[i]n addition to the above clinical and statistical concerns, the review team has substantial concerns about product manufacturing. Those issues have yet to be resolved.”
On this news, Brainstorm Cell’s stock price fell $0.19 per share, or 47.46%, to close at $0.20 per share on September 28, 2023.
WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers.
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Attorney Advertising. Prior results do not guarantee a similar outcome.
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Contact Information:
Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com
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