Kaival Brands Innovations Group Inc (NASDAQ: KAVL) stock price rallied 92% after its Bidi Vapor asked the FDA to lift the marketing denial order on its Bidi sticks.
The US Food & Drug Administration issued an administrative stay of its marketing denial order (MDO) on October 22, 2021, and Bidi wants the entire order rescinded.
The FDA allowed Bidi’s non-tobacco flavored stocks to remain on the market as it reviewed the company’s request to reverse the order based on scientific evidence.
Bidi told the FDA that it had presented product-specific scientific evidence within its Premarket Tobacco Product Applications that warrant lifting the order.
According to the company, behavioural studies demonstrate Bidi sticks can be an alternative to cigarettes among smokers and may helo them transition away from smoking cigarettes.
The company has filed a petition with the U.S. Court of Appeals for the Eleventh Circuit, seeking a judicial review of the MDO. The company has asked the appellate court to vacate the MDO and provide additional relief where necessary.
Kaival Brands benefitted from Bidi Vapor’s move since it is the sole global distributor of products made by the company.
Kaival recently raised $8 million via a public stock offering in late September and entered the UK market, acting as a launchpad for its international operations.
The move to diversify out of the US market was primarily prompted by the FDA’s decision to ban its marketing activities within the country.
Investors cheered today’s move, but Kaival shares had given up most of their gains by the time of publishing.
*This is not investment advice.
Kaival Brands stock price.
Kaival Brands stock price rallied 92% to trade at $2.92, rising from Tuesday’s closing price of $1.52.