mpany announced receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its New Drug Application (“NDA”) for BIV201, a treatment for refractory ascites due to liver cirrhosis. The FDA issued the CRL after the completion of its review of the NDA, and the CRL advised that the FDA had determined it could not approve the NDA in its present form. The Company stated that the CRL identified various deficiencies, including issues related to the conduct of the Phase 2b trial for BIV201.
The class action lawsuit alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, the lawsuit claims that Defendants failed to disclose to investors: (1) that the Company’s Phase 2b trial for BIV201 was inherently flawed; (2) that the CRL from the FDA regarding the Company’s NDA for BIV201 reflected the failure of that trial; (3) that as a result, the Company’s NDA for BIV201 was unlikely to be approved; and (4) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
If you wish to learn more about this lawsuit or are interested in being the lead plaintiff, please contact us at Kirby McInerney LLP at 212-371-6600, by email at investigations@kmllp.com, or by filling out this contact form. You need not be a member of the class to seek appointment as a lead plaintiff. The lawsuit has not been certified, and until certification occurs, you are not represented by an attorney.
Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, and whistleblower litigation. The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP’s website: http://www.kmllp.com.
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Contacts
Kirby McInerney LLP
Thomas W. Elrod, Esq.
212-371-6600
investigations@kmllp.com
http://www.kmllp.com
As a magazine editor, it’s important to provide a balanced and informative article for your readers. Here’s an expanded version of the press release for your readers:
Kirby McInerney LLP, a New York-based plaintiffs’ law firm, has announced the filing of a class action lawsuit in the U.S. District Court for the District of Nevada on behalf of investors who acquired BioVie, Inc. (“BioVie” or the “Company”) (NASDAQ: BIVI) securities during the period of August 5, 2021 through November 29, 2023. The lawsuit alleges that the Company and its executives made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects.
The lawsuit specifically claims that the Company’s Phase 2b trial for BIV201 was inherently flawed and that the Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its New Drug Application (“NDA”) for BIV201 reflected the failure of that trial. It further alleges that the NDA for BIV201 was unlikely to be approved and that Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and lacked a reasonable basis.
Investors who acquired BioVie, Inc. (“BioVie” or the “Company”) (NASDAQ: BIVI) securities during the specified period have until March 19, 2024 to apply to the Court to be appointed as lead plaintiff in the lawsuit. To learn more about this lawsuit or to express interest in being the lead plaintiff, individuals may contact Kirby McInerney LLP at 212-371-6600, by email at investigations@kmllp.com, or by filling out a contact form on their website.
Kirby McInerney LLP has a concentration in securities, antitrust, and whistleblower litigation, and their efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. The firm’s website, http://www.kmllp.com, provides additional information about the services they provide.
For more information or to express interest in the lawsuit, readers are encouraged to contact Kirby McInerney LLP at their provided contact information.
This article provides an overview of the class action lawsuit filed against BioVie, Inc. and aims to inform readers about the allegations and deadlines related to the lawsuit. It also offers a resource for readers who may be interested in learning more or getting involved.
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