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Kaival Brands Innovations Group Inc KAVL

Kaival Brands Innovations Group, Inc. is engaged in the sale, marketing, and distribution of electronic nicotine delivery system (ENDS) products, also known as e-cigarettes, in a variety of favors. The Company’s primary product is the Bidi Stick as well as other products manufactured by its affiliate Bidi Vapor LLC (Bidi). It holds the worldwide right to market and distribute the Bidi Stick and certain other products manufactured by Bidi. Bidi Stick is a disposable, tamper resistant ENDS product made with medical-grade components, a battery and technology designed to deliver a consistent vaping experience for adult smokers 21 and over. It distributes products to wholesalers and retailers of ENDS products. BIDI Stick comes in a variety of flavor options for adult cigarette smokers. It does not manufacture any of the products it resells. Its patent portfolio consists of approximately 19 existing and 47 pending with technologies related to vaporization and inhalation technologies.


NDAQ:KAVL - Post by User

Post by AveragePennyon Feb 04, 2022 1:02pm
73 Views
Post# 34398382

Bidi Vapor Wins Judicial Stay of FDA's Marketing Denial

Bidi Vapor Wins Judicial Stay of FDA's Marketing Denial

GRANT, Fla.Feb. 3, 2022 /PRNewswire/ -- Kaival Brands Innovations Group, Inc. (NASDAQ: KAVL) ("Kaival Brands," the "Company," or "we"), is the exclusive global distributor of products manufactured by Bidi Vapor LLC ("Bidi Vapor"), including the BIDI® Stick disposable electronic nicotine delivery system ("ENDS"), which is intended exclusively for adults 21 and over. The Company is pleased to announce that the U.S. Court of Appeals for the Eleventh Circuit has granted a judicial stay of the marketing denial order ("MDO") previously issued by the U.S. Food and Drug Administration ("FDA") to Bidi Vapor in September 2021.

The ruling, issued on February 1, 2022, allows Bidi Vapor and Kaival Brands to market and sell all of its BIDI® Stick ENDS, including its tobacco, menthol and flavored products, while Bidi Vapor continues with its merits lawsuit compelling the FDA to place Bidi Vapor's Premarket Tobacco Product Application ("PMTA") for the flavored ENDS back under scientific review.


With the judicial stay decision going in favor of Bidi Vapor, the Company expects many distribution partners to reestablish their previous sales volumes, with potentially new distribution chains added as well.

https://www.prnewswire.com/news-releases/bidi-vapor-wins-judicial-stay-of-fdas-marketing-denial-order-301474799.html


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