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Kaival Brands Shares Rise 90% Premarket After FDA Stay of Bidi Vapor Products Denial Order

By Chris Wack

 

Kaival Brands Innovations Group Inc. shares were up 90% to $2.89 in premarket trading Wednesday after the company said Bidi Vapor LLC, the manufacturer of the premium BIDI Stick electronic nicotine delivery system, said the U.S. Food and Drug Administration issued an administrative stay of its marketing denial order for non-tobacco flavored BIDI Sticks.

Kaival Brands is a global distributor of Bidi Vapor products.

The hold will remain pending the FDA's review of the company's request that the marketing denial order be rescinded based on product-specific scientific evidence in its Premarket Tobacco Product Applications.

The FDA confirmed that while it reviews Bidi Vapor's request, its flavored BIDI Sticks can remain on the market without the threat of enforcement.

Prior to the court-ordered Sept. 9, 2020, premarket tobacco product application deadline, Bidi Vapor submitted premarket tobacco product applications for all 11 flavor varieties of its BIDI Stick, which is intended exclusively for adult cigarette smokers and tobacco users, 21 and over. Despite submitting the premarket tobacco product applications and keeping the FDA informed about its ongoing clinical and behavioral studies, Bidi Vapor received an MDO for its flavored BIDI Sticks, along with nearly all other manufacturers of flavored ENDS, in early September 2021.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

October 27, 2021 09:39 ET (13:39 GMT)

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