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Bullboard - Stock Discussion Forum 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... see more

NDAQ:KAVL - Post Discussion

Kaival Brands Innovations Group Inc > Bidi Vapor Wins Judicial Stay of FDA's Marketing Denial
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Post by AveragePenny on Feb 04, 2022 1:02pm

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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