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KAVL: 'PROFITS', that's what you're "missing here".
$KAVL Kaival Brands Partner Bidi Vapor to Contest FDA Denial of ‘Classic’ Tobacco-Flavored ENDS
https://www.globenewswire.com/news-release/2024/01/29/2818885/0/en/Kaival-Brands-Partner-Bidi-Vapor-to-Contest-FDA-Denial-of-Classic-Tobacco-Flavored-ENDS.html
MDO applies only to one Bidi device, ten other flavors still in PMTA process
Kaival Brands remains focused on driving revenue and platform diversification
GRANT-VALKARIA, Fla., Jan. 29, 2024 (GLOBE NEWSWIRE) -- Kaival Brands Innovations Group, Inc. (NASDAQ: KAVL) ("Kaival Brands," the "Company" or "we,” “our” or similar terms), a company focused on incubating and commercializing innovative products into mature and dominant brands, with a current focus on the distribution of electronic nicotine delivery systems (ENDS), which are intended for adults 21 and over, today announced that its licensor and commercial partner, Bidi Vapor LLC (Bidi Vapor), will appeal the U.S. Food and Drug Administration’s (FDA) decision to deny Bidi Vapor’s premarket tobacco product application (PMTA) for Bidi Vapor’s “Classic” tobacco-flavored BIDI® Stick ENDS device. Kaival Brands holds the worldwide license to distribute products made by Bidi Vapor.
On Monday, January 22, 2024, the FDA issued a marketing denial order (MDO) for Bidi Vapor’s “Classic” BIDI® Stick PMTA. Importantly, this decision did not involve the ten PMTAs for Bidi Vapor’s non-tobacco flavored devices which are still under the FDA’s scientific review. Those ten products remain available for sale through Kaival Brands, subject to FDA’s enforcement discretion.
In response to the MDO, on Friday, January 26, 2024, Bidi Vapor filed a petition requesting that the U.S. Court of Appeals for the Eleventh Circuit review the MDO, which Bidi Vapor believes was, among other things, arbitrary and capricious, in violation of the Administrative Procedure Act. Bidi Vapor will also be seeking a stay of the MDO pending the outcome of the litigation.
“Bidi Vapor disagrees with the FDA’s decision and is taking immediate action accordingly,” said Niraj Patel, the Founder & Chief Executive Officer of Bidi Vapor, who is also the Chief Science Officer & Founder of Kaival Brands. “In the meantime, it is important to note that the decision only affects the ‘Classic’ or tobacco-flavored BIDI® Stick. The remaining ten BIDI® Stick flavors are still under FDA scientific review and remain in distribution in the United States through Kaival Brands, subject to the FDA’s enforcement discretion.”
Bidi Vapor has a history of successful outcomes when contesting adverse FDA decisions, having received a favorable Eleventh Circuit ruling in August 2022 that set aside the original MDOs received for its ten non-tobacco flavored products. That ruling put the ten PMTAs back into scientific review and allowed those flavors to remain available for sale pursuant to the FDA’s compliance policy for deemed tobacco products. During this evaluation period, the ten non-tobacco flavored products are still under FDA enforcement discretion.
“While we are disappointed with the FDA’s decision, we are in close contact with Bidi Vapor and laser focused on selling the Bidi Vapor products that we are permitted to,” said Barry M. Hopkins, Executive Chairman of Kaival Brands. “Like Bidi Vapor, we are fully committed to the legal and responsible use of our products. Moreover, we are committed to increasing Kaival Brands’ revenues by strengthening our existing business and also diversifying our product portfolio, as evidenced by the intellectual property we acquired in May 2023 from GoFire, Inc. We look forward to providing progress updates on our initiatives over the course of 2024.”
$KAVL Kaival Brands Innovations Group, Inc. - S-1/A - Registration Statement - January 12, 2024
https://fintel.io/doc/sec-kaival-brands-innovations-group-inc-1762239-s1a-2024-january-12-19734-9506?utm_source=twitter.com&utm_medium=referral&utm_campaign=filing
TheStreetReports: Disruptive Technology Stocks in Focus – $KAVL, $SONM, $PBTS, $IPA
https://www.marketwatch.com/press-release/thestreetreports-disruptive-technology-stocks-in-focus-kavl-sonm-pbts-ipa-2023-04-18
March 13, 2023 - Kaival Brands Innovations Group, Inc. (NASDAQ: KAVL) ("Kaival Brands," the "Company" or "we," "our" or similar terms), the exclusive distributor of all products manufactured by Bidi Vapor, LLC ("Bidi Vapor"), including the BIDI® Stick electronic nicotine delivery system (ENDS), which are intended for adults 21 and over, today highlights the official launch of the VEEBA disposable e-vapor product across the United Kingdom, reported by Philip Morris Limited, UK and Ireland (PML), on February 27, 2023.
This past summer, Philip Morris Products S.A. (PMPSA), a subsidiary of Philip Morris International (PMI) entered into a licensing agreement with a subsidiary of Kaival Brands, allowing for the patents, methods and technology to develop products based on the premium, self-contained ENDS called the BIDI® Stick, the No. 1-selling, self-contained ENDS device in the United States according to data from New York-based Nielsen. The VEEBA device is a result of this agreement.
As reported by Philip Morris Limited, UK and Ireland, at the time of launch: “In accordance with PMI’s responsible marketing practices, VEEBA’s packaging, device and flavor descriptors have been specifically designed to appeal to adult smokers only. VEEBA has not been commercialized with flavor descriptors that may appeal to youth, such as images or descriptions of candies or desserts, or brightly colored or flashy devices or packaging. Instead, subtle colors and functional flavor descriptors work together with PML’s youth-access prevention program, to focus on providing existing adult nicotine users and adult smokers with access to VEEBA.”
Nirajkumar Patel, Chief Science and Regulatory Officer of Kaival Brands, says, “VEEBA and BIDI® Stick are science-based, premium, responsible, recyclable and disposable devices, developed specifically for use by adult smokers and existing adult nicotine users who are looking for a better alternative to continued smoking. Retailers can feel assured that by listing BIDI® Stick here in the United States—or VEEBA outside of the United States—they are stocking a smoke-free product that adheres to local laws and in many cases, strives to go even further.”
In addition, recycling programs for VEEBA and BIDI® Stick enable and encourage users to dispose of used devices in a responsible and sustainable manner, with products cleaned and separated by material type, and then recycled into raw formats that manufacturers can use to make new products.
“The U.K. represents a top market for the international distribution of VEEBA with a mature and educated vaping community. Since the official launch of VEEBA in Canada last year, we are encouraged to see additional market expansions, which in turn creates additional royalty payments for the sale of each unit that is manufactured and sold,” said Eric Mosser, President and Chief Operating Officer of Kaival Brands. “A responsible, disposable device that can fulfil the needs of existing adult nicotine users is now available in additional international markets, and we look ahead to future growth while striving for excellence in quality, compliance, and sustainability.”
Probably also the buying and pop today.
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