NetworkNewsBreaks – Kaival Brands Innovations Gr
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Posted On: 09/09/2021 4:52:56 PM
NetworkNewsBreaks – Kaival Brands Innovations Group Inc.’s (NASDAQ: KAVL) Manufacturing Partner Moves to Final Phase of Regulatory Authorization
Kaival Brands (NASDAQ: KAVL), a company focused on developing products into mature, dominant brands, is the exclusive global distributor of a portfolio of premium vape products manufactured by Bidi(R) Vapor LLC. Notably, the Bidi(R) Stick electronic nicotine delivery systems (“ENDS”) product lineup, offering 11 different flavors, followed a regulatory pathway that required the company to submit Premarket Tobacco Product Applications (“PMTAs”). The submission sought authorization to market specific tobacco products introduced after Feb. 15, 2007, unlike any of those previously grandfathered in. “Bidi’s PMTAs have passed the first two phases: received an acceptance letter from the FDA for the PMTA and subsequently received a filing letter indicating the application has met the FDA’s baseline criteria, allowing it to move into the final phase,” reads a recent article. “The ‘substantive’ phase involves the FDA’s scientific review of the PMTA and associated data. Bidi and Kaival are waiting for a final decision in the coming weeks, with an approval officially designating the products as ‘appropriate for the protection of public health.’”
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
Kaival Brands (NASDAQ: KAVL), a company focused on developing products into mature, dominant brands, is the exclusive global distributor of a portfolio of premium vape products manufactured by Bidi(R) Vapor LLC. Notably, the Bidi(R) Stick electronic nicotine delivery systems (“ENDS”) product lineup, offering 11 different flavors, followed a regulatory pathway that required the company to submit Premarket Tobacco Product Applications (“PMTAs”). The submission sought authorization to market specific tobacco products introduced after Feb. 15, 2007, unlike any of those previously grandfathered in. “Bidi’s PMTAs have passed the first two phases: received an acceptance letter from the FDA for the PMTA and subsequently received a filing letter indicating the application has met the FDA’s baseline criteria, allowing it to move into the final phase,” reads a recent article. “The ‘substantive’ phase involves the FDA’s scientific review of the PMTA and associated data. Bidi and Kaival are waiting for a final decision in the coming weeks, with an approval officially designating the products as ‘appropriate for the protection of public health.’”
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
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