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Good news, but still cloud over this because, all this does is require them to take another look, they still can reissue same MDOs at the end of it all. Not sure if any other companies have been cleared for flavored products.. Maybe Kaival will be the trend setter.
hopefully itll hold this time
Already traded 6.8 million pre-market…
Up 40 cents!!
Bidi Vapor Wins Merits Case Against FDA; Kaival Brands Anticipates Revenue Growth From Decision
August 25 2022 - 08:30AM
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Kaival Brands Innovations Group, Inc. (NASDAQ: KAVL) (“Kaival Brands,” the “Company,” or “we”), the exclusive U.S. distributor of products manufactured by Bidi Vapor, LLC (“Bidi Vapor”), including the BIDI® Stick self-contained electronic nicotine delivery system (“ENDS”), which is intended exclusively for legal-age nicotine users, announced that the U.S. Court of Appeals for the Eleventh (11th) Circuit has ruled 2-1 in Bidi Vapor’s favor, granting its petition for review, and setting aside and remanding as arbitrary and capricious the U.S. Food and Drug Administration’s (“FDA”) order denying the Premarket Tobacco Product Applications (“PMTA”) for the non-tobacco flavored BIDI® Sticks.
Failure by FDA to Consider Marketing Plans and Sales-Access-Restrictions
On August 23, 2022, the 11th Circuit held that FDA’s Marketing Denial Order (“MDO”) issued against Bidi Vapor’s non-tobacco flavored ENDS devices was “arbitrary and capricious,” primarily because FDA failed to consider the relevant marketing and sales-access-restrictions plans included in Bidi Vapor’s comprehensive PMTAs.
“Distribution in the ENDS market has been challenging to say the least, especially regarding compliance with FDA policies and procedures. As the exclusive U.S. distributor of Bidi Vapor’s products, this is a significant event for us and our downstream partners, as many awaited the decision before expanding distribution, and paves the way for potential revenue growth for our company,” said Eric Mosser, President and Chief Operating Officer of Kaival Brands.
“But more than that, we are glad the appellate court recognized the potential importance and direct effects that an adult-focused marketing plan and strict sales and access restrictions may have on addressing the youth access problem,” continued Mr. Mosser. “We strongly believe that the appeal to and illegal usage by youth can be significantly reduced, not by banning flavors which are necessary for adult smokers seeking non-combustible alternatives to cigarettes, but with responsible marketing, adult-oriented packaging, restrictive online access, and enforcement of the current laws and regulations to force out bad actors marketing illegal and counterfeit products.”
In the majority opinion, the Court stated that FDA needed to consider relevant marketing strategies and plans surrounding access and restrictions around minors included in the PMTAs, and not simply disregard those plans as historically insufficient. “The FDA offers its experience as its primary excuse for its refusal to consider the marketing and sales-access-restriction plans,” the Court’s majority ruled. “Experience fails as a justification...”
The majority also noted that administrative “efficiency” – i.e., quickly reviewing the many PMTAs submitted to FDA – was not an “excuse,” saying, “by definition, the requirement that federal agencies consider all ‘relevant factors,’ prohibits agency shortcuts.”
While the majority focused on FDA’s failure to review Bidi’s marketing plans and sales and access restrictions, the majority further noted, with respect to Bidi Vapor’s applications, that FDA also failed to consider key evidence including, among other things, “product information, scientific safety testing, literature reviews, consumer insight surveys, and details about the company’s youth access prevention measures, distribution channels, and adult-focused marketing practices,” which “target only existing adult vapor product users, including current adult smokers,” as well as Bidi Vapor’s state-of-the-art anti-counterfeit authentication system and retailer monitoring program.
At the time of this press release, FDA has not announced its plans moving forward. The agency could appeal the ruling or put Bidi Vapor’s PMTAs for its non-tobacco flavored devices into scientific review. The Court ruling “remands”, or sends, the applications back to the FDA for action. The dissenting judge sided with FDA and its arguments that it has not seen any marketing or access plans that would reduce youth access, or that non-tobacco flavored vaping products offer an advantage over tobacco-flavored vaping products in decreasing smoking among existing smokers, despite the fact that FDA admittedly did not even review Bidi Vapor’s submitted marketing plan or other evidence.
“We believe that Bidi Vapor has provided FDA with substantial, robust and reliable scientific evidence through, among other things, surveys, behavioral studies and clinical trials on our BIDI® Stick products. We are confident the science will prove that the BIDI® Stick is appropriate for public health (APPH),” noted Kaival Brands Chief Science Officer and Founder, Niraj Patel. “Following on FDA’s initial administrative stay of the MDO, we believed that the subsequent judicial stay was a good indication that the Court found some merit in Bidi Vapor’s arguments and puts Bidi Vapor's PMTAs for the non-tobacco flavored ENDS one step closer to being properly and fully evaluated by the FDA. Bidi Vapor’s victory in our merits case confirms our prior beliefs. We look forward to cooperating with the agency through the scientific review process.”
Leading with Integrity
Bidi Vapor submitted PMTAs for all 11 flavor varieties (nine flavored ENDS plus menthol and tobacco) of its BIDI® Stick prior to the court-ordered September 9, 2020 PMTA deadline. The detailed applications ran over 285,000 pages and contained significant information supporting the products as appropriate for the protection of the public health – including robust and reliable scientific data supporting that its non-tobacco flavored BIDI® Sticks provide an added benefit to adult smokers over tobacco-flavored ENDS.
Despite submitting scientifically rigorous PMTAs and keeping FDA informed about its ongoing clinical and behavioral studies, among other things, Bidi Vapor received an MDO for its non-tobacco flavored BIDI® Sticks, along with nearly all other manufacturers of such flavored ENDS, in early September 2021. On September 29, 2021, Bidi Vapor filed a Petition for Review of the MDO with the 11th Circuit. That MDO was initially administratively stayed by FDA; after that administrative stay was lifted in December 2021, the 11th Circuit stayed the MDO on February 1, 2022. Oral arguments were heard on May 17, 2022 in Miami, Florida.
On August 23, 2022, the 11th Circuit ruled on the Petition for Review in favor of Bidi Vapor. This ruling effectively reverses the MDO and allows Bidi Vapor to continue to market all flavor varieties of the BIDI® Stick in the United States. All ENDS product on the market today that do not have marketing authorization from FDA are subject to enforcement, at the Agency’s discretion.
Since its MDO was issued, Bidi Vapor has continued to supplement its comprehensive PMTAs with additional science, including clinical and behavioral studies supporting that its products are APPH, which Bidi Vapor believes FDA must now also consider on remand as part of a full scientific review of its applications.
ABOUT BIDI VAPOR
Based in Melbourne, Florida, Bidi Vapor maintains a commitment to responsible adult-focused marketing, strict youth access prevention measures and age-verification standards, as well as sustainability through its BIDI® Cares recycling program. Bidi Vapor’s device, the BIDI® Stick, is a premium product made with high-quality components, a UL-certified battery and technology designed to deliver a consistent vaping experience for adult smokers 21 and over. Bidi Vapor is also adamant about strict compliance with all federal, state, and local guidelines and regulations. At Bidi Vapor, innovation is key to its mission, with the BIDI® Stick
Mansax… I think you’re spot on. The Philip Morris connection is going to open doors and windows that can’t help but increase the bottom line!
I spect anticipation of the next quarterly report will bring out some higher highs.
Plus, if the FDA green light turns on, I think all bets are off. Share price will precede revenue and profits because then it will just be a matter of time!
Would like to see the agreement terms.
This chain is clearly broken.................for now
Clearly another link in the chain!
Selling has the same effect regardless of why the selling is occurring. The ceo put out notice a while back that he is selling. My guess is it is part of the deal with PM. They don't want him to have so many shares when they can let their insiders buy them.
Wait till they start attaching some revenues to these releases.
I had a feeling something was brewing from that after hours volume
Someone is buying lots of this. Should run to 2.50 soon
Yep looking good. Grabbed some 1.68s
International Licensing Agreement between Kaival Brands & Philip Morris International Moves into Next Phase
July 25 2022 - 08:02AM
Bidi Vapor IP, patents, and development methods used to launch VEEBA outside of the U.S.
GRANT, Fla., July 25, 2022 /PRNewswire/ -- Kaival Brands Innovations Group, Inc. (NASDAQ: KAVL) ("Kaival Brands," the "Company," or "we"), today reported on the launch of PMI's custom-branded self-contained e-vapor product, VEEBA, in Canada. This follows a recently announced international licensing agreement with Philip Morris Products S.A. Kaival Brands is the U.S. distributor of all products manufactured by Bidi Vapor, LLC ("Bidi Vapor"), which are intended for legal-age nicotine users.
(PRNewsfoto/Kaival Brands)
Bidi Vapor IP, patents, and development methods used to launch VEEBA outside of the U.S.
The product, a self-contained e-vapor device, VEEBA, has been custom developed and is now being distributed in Canada, pursuant to the licensing agreement. The agreement covers the development, licensing, and distribution of ENDS products in certain markets outside of the United States, pending further regulatory assessments.
"The Agreement with Philip Morris Products was a remarkable accomplishment for the company and now we have advanced to the next phase of international distribution with the actual launch of their custom branded product, VEEBA. We are excited to support PMI's efforts to provide a range of alternatives compared to cigarettes. The commercialization of VEEBA complements PMI's already strong smoke-free portfolio, providing adult smokers with an even broader range of usage, taste, price, and technology options," said Eric Mosser, President and Chief Operating Officer of Kaival Brands.
The International Agreement grants to PMPSA a license of certain intellectual property rights relating to KBI's premium ENDS device, known as the BIDI® Stick in the U.S., as well as potentially newly developed devices, to permit PMPSA to manufacture, promote, sell, and distribute such ENDS device and newly developed devices, in certain international markets, outside of the United States, with potential royalties owed to KBI as per the terms of the Agreement.
ABOUT BIDI VAPOR
Based in Melbourne, Florida, Bidi Vapor maintains a commitment to responsible adult-focused marketing, strict youth access prevention measures, and age-verification standards, as well as sustainability through its BIDI® Cares recycling program. Bidi Vapor's device, the BIDI® Stick, is a premium product made with high-quality components, a UL-certified battery, and technology designed to deliver a consistent vaping experience for adult smokers 21 and over. Bidi Vapor is also adamant about strict compliance with all federal, state, and local guidelines and regulations. At Bidi Vapor, innovation is key to its mission, with the BIDI® Stick promoting environmental sustainability, while providing a unique vaping experience to adult smokers.
Mr. Patel, the Company's Chief Science and Regulatory Officer, owns and controls Bidi Vapor. As a result, Bidi Vapor and the Company are considered under common control and Bidi Vapor is considered a related party.
For more information, visit www.bidivapor.com
ABOUT KAIVAL BRANDS
Based in Grant, Florida, Kaival Brands Innovations Group, Inc., is a company focused on growing and incubating innovative and profitable products into mature and dominant brands in their respective markets. Our vision is to develop internally, acquire, own, or exclusively distribute these innovative products and grow each into dominant market-share brands with superior quality and recognizable innovation. Kaival Brands and Philip Morris International Inc. are the exclusive global distributors of products manufactured by Bidi Vapor.
Learn more about Kaival Brands at www.ir.kaivalbrands.com
I think it is a very good time to own KAVL, very
The volume the last 5 days in the after hours is very strange
What's up with the jump in SP the last couple of days. Anyone hear anything or is it a "dead cat bounce"?
$KAVL Vaping Industry Reacts as FDA Deadline on Synthetic Nicotine Arrives
https://www.prnewswire.com/news-releases/vaping-industry-reacts-as-fda-deadline-on-synthetic-nicotine-arrives-301586691.html
Kaival Brands supports enforcement of new prohibition on ENDS that use non-tobacco derived or synthetic nicotine
GRANT, Fla., July 14, 2022 /PRNewswire/ -- Kaival Brands Innovations Group, Inc. (NASDAQ: KAVL) ("Kaival Brands," the "Company," or "we"), the U.S. distributor of all products manufactured by Bidi Vapor, LLC ("Bidi Vapor"), which are intended for legal-age nicotine users, today announced its support of statements from Bidi Vapor, regarding its continuing support of the U.S. Food and Drug Administration (FDA)'s authority over electronic nicotine delivery systems (ENDS) devices using non-tobacco derived or "synthetic" nicotine. With the arrival of a major deadline on July 13, 2022 that will make the continued retail and distribution of all such products illegal, the Company hopes the FDA will use its powers to properly enforce its new policies. Bidi Vapor does not use synthetic nicotine in any product.
After July 13th, all synthetic nicotine products on the market will be in violation of the agency's new statutes and will be subject to FDA enforcement, unless they receive a marketing authorization from the FDA by July 13, 2022—a virtual impossibility, said officials with Bidi Vapor, based in Melbourne, Florida.
Retailers who keep these products on their store shelves could also face enforcement and penalties for selling "adulterated" tobacco products, according to the FDA guidelines.
"Now, with this new authority given to the FDA, all products containing nicotine from any source will have to undergo the same rigorous authorization process to legally go to market here in the United States," said Niraj Patel, Chief Science and Regulatory Officer of Kaival Brands. "More importantly, it focuses manufacturers who use synthetic nicotine to align with the FDA's priority of making these types of adult consumer products appropriate for the protection of the public health."
Patel cautioned retailers who continue to sell devices with synthetic nicotine after July 13th. "C-store retailers should pay close attention to what products are permitted for sale and are compliant with the requirements of the FDA, the Prevent All Cigarette Trafficking or PACT Act, and numerous state and local licensing and tax laws," Patel said. "We anticipate that as the FDA begins enforcement against illegally marketed and synthetic-nicotine vaping products, there may be an increased demand for the few remaining ENDS products made with tobacco-derived nicotine that are not currently subject to marketing denial orders, such as the BIDI® Stick."
Bidi Vapor announced its official position on synthetic nicotine in the Company's financial report published on September 14, 2021. It also shared its opinion directly with members of Congress and FDA leadership, most recently in letters to Dr. Robert Califf, the FDA commissioner, as well as Dr. Brian King, the new Director of FDA's Center for Tobacco Products.
"We hope retailers take a serious look at who their partners are," Patel said. "You want to partner with companies that comply with regulations and produce high-quality products. That's the only way the industry will survive and thrive in the future, prevent youth-access, and continue to offer adult smokers alternatives to combustible cigarettes."
Mr. Patel, the Company's Chief Science and Regulatory Officer, owns and controls Bidi Vapor. As a result, Bidi Vapor and the Company are considered under common control and Bidi Vapor is considered a related party.
Theyre selling off anything they can now to make a run for thr exit before the company goes tits up. Watch in a few weeks Phillip Morris will make a purchase of Bidi from poohinder and they'll settle the contract with kavl by paying off the officers and the shareholders will be left holding bags
Another filing after the close. Are these guys taking us to the cleaners!!
Guess those in the know, sold at the $3 range and are buying it back now. Again, knowing what we do not
Niraj and Eric are making a killing!!!
I love how you're still trying to at least be optimistic. I wish I still had some of that in me.
And the dump begins. News at 6:08 this morning and lookout below. Unless they are selling to PM/Altria..........
Theyre getting ready to dump a massive amount of ahares on everyone before Poohinder sells bidi to Phillip Morris when he gets deported back to India because of SEC fraud and violations. These retards have never done anything in the best interests of any shareholders other than themselves.
Need to know who is running the ship now.
So is Eric Mosser still active at either of his former companies, where he is still listed as principal and employed, Chillcorp and Lasermycig? Looks like he has his wife or another Mosser watching Chillcorp. Time to dig in and see who these people really areSo is Eric Mosser still active at either of his former companies, where he is still listed as principal and employed, Chillcorp and Lasermycig? Looks like he has his wife or another Mosser watching Chillcorp. Time to dig in and see who these people really are
ImO.. Patel steps aside to work on another project while this bad boy runs itself... he's still on the board and very much involved with important decisions... watch for him to release a new product in a few months to add to the current product line... totally imo.. ppl selling on the news.. so grab some cheapies...
Interesting shuffling of the deck here.
Hopefully this is at the request of Phillip Morris and we start to see some movement based on the new partnership.
So is Eric Mosser still active at either of his former companies, where he is still listed as principal and employed, Chillcorp and Lasermycig? Looks like he has his wife or another Mosser watching Chillcorp. Time to dig in and see who these people really are. What makes Mosser worthy of this position?
Poor leadership, which just got even worse than it was.
Exactly, don’t know why it’s dropping
Hard to believe with recent news
this from most recent $PM 10q - shows $2.35B last qtr for reduced risk product- does that include chew and vape products? back of napkin calcs - say 4b annually is vape rev and 1b of that is $KAVL product x 2.75%= $27.5m annually to kavl pic.twitter.com/Jw6cMNaULZ
— rstar (@sixonehalfdoz) June 15, 2022
An offering will be coming any day now my bet is within the week.
KAVl: Decent Close on the day. There are a lot of ONE-DAY-WONDERS in the markets these days. But KAVL --- with PHILLIP MORRIS onboard now --- just might do pretty well for a LONG time. (See ya-all tomorrow!)
https://pulse2.com/kaival-brands-kavl-stock-price-why-it-surged-over-40-today/
https://www.prnewswire.com/news-releases/kaival-brands-reaches-agreement-with-philip-morris-international-for-international-electronic-nicotine-delivery-system-product-distribution-301566929.html
Ahh, I remember back when I was optimistic and bullish on this turd. 2+ years ago. Either way, I hope you're right and I'm wrong so I can finally break even on this hot garbage.
He WON'T, Dude --- fret not.
Just hope the amateur hour CEO doesn't go full retard and kill momentum
$kavl 4x the float going to at least trade today- shorts gonna get trapped-
licensing bidi stick to $153B dollar Phillip Morris is worth what?
I'd say more than the current market cap minimum.
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