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Here is to .50+!
Thanks - unfort. I've been fully invested into this and XXII for 2 years plus... I wish I could get into XXII at current price point... a steal IMO but check them out... GL... risky but high reward...
I believe both will finally explode before the end of this year... GL!
I just mean to bring true authority to the medicine... FDA seal of approval is key... no?
Yes we can market and make $... but... let's become like GWPH
Probably need FDA approval to get to boss level
A surprisingly one-sided viewpoint from Craver... 22nd Century's FDA hearing results draw eye-of-beholder responses
But who cares - all the more reason it'll pass IMO ... so one-sided its source appears to be fear
https://www.journalnow.com/business/nd-century-s-fda-hearing-results-draw-eye-of-beholder/article_dfe5f1f4-4027-5340-a0df-7f8e4cfc208f.html
Just wish I didn't buy at .10 :)
I'm looking for .50+ before selling...
He's back! Thank God.
Thanks
Curious - how'd you hear of Zelira? I'm from the US and invested for about 2 years... I do think by the end of this year, there should be movement in share price.
Worth watching:
Need to give this company til end of year to prove itself...
Positive highlights... MRTP, real-world study, NPRM... can't repeat it enough... https://www.mdmag.com/medical-news/low-nicotine-cigarettes-fda-advisory-committee
Then why did they speak out against VLN in TPSAC Meeting? Out of the health and well-being of people?
You know what's funny? Only Reynolds, owned by BAT (their former collaborator... when you say BT), was the only BT Rep anti XXII at TPSAC... I look forward to seeing them fall hard and fast.
Zeller's tone was so no non-sense - was extremely reassuring, FYI
Same team here...
Indeed
That's correct
More importantly, we're on our way to non-GMO VLN which is required to disrupt European market... how far behind, do you think, is BT from developing non-GMO VLN...
I can wait another month or two for MRTP status...
That's not VLN - that's increased nicotine. I can't believe you're returning to the patent argument now... try again.
“Based on the success of the meeting, the FDA’s public statements at the meeting and in its briefing document published ahead of the meeting, as well as the FDA’s previous guidance about the timing of its reviews of MRTP applications in general, we believe the FDA is likely to reach a decision on our MRTP application sometime in the second quarter of this year.
April, May, and June (Q2)
Beyond THC and CBD: Next Cannabinoids in Demand
Because it's the only way they'll get MRTP for IQOS - just a hunch. I could be wrong. I'm not putting my 'name' to it, unlike everything else I've predicted. Real-world study (whether Moonlight, or Marlboro VLN) then NPRM based on positive results... this is the rest of our story, for sure.
Here is a theory: IQOS gets MRTP only after PM collaborating with XXII... I say small chance but possible backdeal
Here is a theory: IQOS gets MRTP only after collaborating with XXII... I say small chance but possible backdeal
bump
Anyone agree with me after today?
We get approved, with conditions, then positive data (which we'll make sure is positive) supports relaunch of NPRM
Hey - our website got refreshed!
https://www.xxiicentury.com/
Yeah - clearly, Zeller not leaving VLN to chance hence the prior recs.
All clear now... with these nancies on the advisory committee.
So... yes with conditions?
Or they make the LEAP... and see if it works, then remove MRTP if NOT
Look at the last Discussion Question... what a setup to argue for NPRM on final point!
Based on real-world data... yes... read it somewhere... any1 feel free to challenge... it's insignificant - we have a winning product... we need to conduct the right type of real-world study after getting designation tomorrow to support NPRM...
Are you kidding? 1-5? A joke.
Have you even browsed ours? It's airtight.
Don't forget - MRTP designation can be rescinded from any product... it's conditional based on the data...
...real-world study, then NPRM, then we go international... other countries waiting on our framework... watch and see
ALL COMING TO FRUITION - that's what simpletons on this Board don't understand - read, reflect, connect the dots
Here's to taking a stand against BT - GL to us tom.
James Vail
Thank you for the e-mail. We are currently all hands on deck preparing for tomorrow's TPSAC presentation of our VLN and VLN Menthol cigarettes. We'll be updating shareholders soon regarding Keygene's progress.
-- Jim
...
Look, I was interested in KeyGene's progress, okay??? Let's get this in the bag tomorrow. Done deal.
Bill Would Require Stores To Be Licensed To Sell Nicotine Products
https://denver.cbslocal.com/video/4444974-bill-would-require-stores-to-be-licensed-to-sell-nicotine-products/
Preliminary results from 2-14???
https://www.fda.gov/media/135146/download
p. 12/top, p. 22/bottom
22nd Century Group’s FDA Advisory Committee Meeting for Reduced Nicotine Content Cigarettes Brings New Standard for the Tobacco Industry
22nd Century Group seeks Modified Risk Tobacco Product marketing authorization for its VLN® and VLN® Menthol Reduced Nicotine Tobacco Products
WILLIAMSVILLE, N.Y.--(BUSINESS WIRE)-- 22nd Century Group, Inc. (NYSE American: XXII)—a plant biotechnology company that is a leader in tobacco harm reduction, reduced nicotine tobacco, and hemp/cannabis plant research—will present the Company’s Modified Risk Tobacco Product (MRTP) application for its reduced nicotine content cigarettes to the U.S. Food and Drug Administration’s Tobacco Product Scientific Advisory Committee (FDA TPSAC) on Friday, February 14, 2020. This meeting will be the first TPSAC meeting to review a combustible tobacco product application, and the first time it has reviewed a modified exposure claim application.
Committee experts from across public health and medicine will hear from 22nd Century Group and the FDA about 22nd Century’s MRTP application and will then discuss specific areas of interest to the FDA. The Company’s MRTP applications seek a reduced exposure marketing authorization from the FDA to allow 22nd Century’s reduced nicotine content cigarettes to be marketed under the brand name “VLN®” with pack and advertising claims stating that the cigarettes contain “95% Less Nicotine” than conventional tobacco cigarettes, as well as related claims.
Mike Zercher, President of 22nd Century Group, explained: “The presentation of our MRTP application to the FDA’s Scientific Advisory Committee is yet another milestone in the Company’s mission to make available reduced nicotine content products to adult smokers.” Zercher continued: “22nd Century is poised to significantly disrupt the $100 billion U.S. tobacco industry. Our research shows VLN® strongly appeals to adult smokers, and importantly from a public health perspective, former and never smokers have little interest in the product.”
John Pritchard, Vice President of Regulatory Science for 22nd Century Group, who will lead the Company’s presentation to TPSAC, explained: “Over recent years, 22nd Century has invested millions of dollars and countless hours to create and submit comprehensive, science-based applications to FDA for these first-of-their-kind tobacco products. These applications are supported by well over $100 million of independent clinical research conducted at leading institutions and major universities in the United States and elsewhere.
“Late last year, we secured an FDA authorization for our Moonlight® and Moonlight® Menthol brand of reduced nicotine content cigarettes by meeting the PMTA regulatory requirements,” continued Pritchard. “This week, we look forward to presenting an overview of our modified exposure claim application to the FDA’s scientific advisory committee. We believe that all adult smokers have the right to know that our VLN® products have 95% less nicotine than conventional cigarettes; an authorization under the MRTP regulatory pathway will enable this. Moreover, receiving an FDA authorization for VLN® will further advance FDA’s stated goal of achieving a reduced nicotine product standard for all cigarettes sold in the United States, which would be truly game-changing for public health.”
22nd Century’s reduced nicotine cigarettes enable smokers to experience the same taste and smell as they would smoking conventional cigarettes but with minimal exposure to nicotine. The FDA’s own assessment of its plan to regulate nicotine to levels already achieved in VLN® would lead to 5 million additional adult smokers quitting one year after implementation with over 8 million American lives saved by the end of this century.
The public is invited to attend the Tobacco Product Scientific Advisory Committee meeting in Building 31 at the FDA White Oak Campus (Silver Spring, MD). The meeting also will be webcast. Meeting details can be found on the FDA’s website at https://www.fda.gov/advisory-committees/tobacco-products-scientific-advisory-committee/2020-tpsac-meeting-materials-and-information#agenda
Trump administration proposes removing tobacco oversight from FDA
Getting complicated... but I think this headline will push us to get MRTP... for the scientists... they can see this as the one chance for positive change in the industry... so why not approve the sucker
https://www.journalnow.com/business/trump-administration-proposes-removing-tobacco-oversight-from-fda/article_52b9db1c-c53d-5f70-95a8-6286a7f8a47d.html
Maybe a 3-month study
MRTP, real-world study w/ MRTP status, NPRM issued based on study results
https://qz.com/1796866/are-cannabinoids-a-good-sleep-aid/
https://www.einnews.com/pr_news/508260329/panacea-life-sciences-acquires-colorado-hemp-farm-to-complete-seed-to-sale-model
The acquisition purchase price was a combination of cash and stock. The farm is slated to achieve its organic certification in 2020. The plans for Panacea’s hemp farm in 2020 include seed development, experiments with different strains, and leveraging the intellectual capital of our investment partner, 22nd Century (XXII).
XXII was granted an exclusive sublicense in the United States and a co-exclusive sublicense in the remainder of the world, excluding Canada, to patents and patent applications relating to the cannabis plant that are required for the production of cannabinoids, the major active ingredients in the cannabis plant.
Leslie Buttorff, CEO of Panacea commented that “Panacea plans to use the XXII strains in the 2020 and 2021 grow cycles. We are excited to add Needle Rock Farms to our capabilities and it adds to our full seed to sale capabilities. With the addition of the farm, we are no longer dependent on other farmers to meet the needs of our brand of consumer products.”