Bidi Vapor Wins Judicial Stay of FDA Marketing Denial Order, and Shares Soar 92%.
Kaival Brands, the U.S. e-cigarette company that sells the disposable e-cigarette Bidi Vapor, reportedly saw its shares soared 92% last night. It is mainly due to its MDO marketing denial order revocation, which allows it to proceed to PMTA scientific review.
The U.S. Court of Appeals for the 11th Circuit suspended the marketing denial order (MDO) issued by the U.S. Food and Drug Administration to Bidi Vapor in September 2021.
The February 1, 2022 ruling allows Bidi Vapor and Kaival Brands to market and sell their Bidi Stick Electronic Nicotine Delivery Systems (ENDS), including their tobacco, menthol, and flavored products. While Bidi Vapor continues to use its merits litigation to compel the FDA to place Bidi Vapor’s Premarket Tobacco Product Application (PMTA) for flavored ENDS back under scientific review.
With the judicial stay ruling in Bidi Vapor’s favor, the company expects many distribution partners to rebuild their previous sales and potentially add new distribution chains.
“We expect this judicial stay to lead to a rebound in Bidi Stick sales,” said Niraj Patel, president, and CEO of Kaival Brands and Bidi Vapor, in a statement. Many of our wholesale and retail partners have already stopped or slowed their Bidi Stick purchases until we receive a response from the court regarding the likelihood of success in our merits litigation. It is what our wholesale and retail partners have been waiting for.
“We believe that Bidi Vapor has developed substantial, robust, and reliable scientific evidence through surveys, behavioral studies, and clinical trials that the product is suitable for protecting public health,” Patel said. “Following the FDA’s initial administrative stay of the MDO, we believe that the recent judicial stay is a good indication. The court found some merit in Bidi Vapor’s arguments and brought Bidi Vapor’s PMTA one step closer to being properly and fully evaluated by the FDA. We are very pleased with the court’s ruling on this judicial stay and continue to look forward to a successful outcome on the merits.”
“We believe this decision marks a new milestone on the path to providing adult smokers 21 years of age and older with a viable alternative to combustible cigarettes. Distributors, wholesalers, retailers, and adult consumers are eager to see positive results for Bidi Vapor and the e-cigarette industry as a whole. We believe in science-based ENDS regulation and hope that the courts will require the FDA to comply with the law when reviewing Bidi Vapor’s PMTA,” Patel said.