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Short-term clinical trials... health providers... check out this Q/A... glad they're getting ready for regulations in the US, like Zelira Therapeutics
https://www.westword.com/marijuana/csu-grad-donates-15-million-for-university-cannabinoid-lab-11622399
A lot of customers ask us about dosing, and we still can’t really give them an answer. This is the exact problem Zelira seeks to solve.
So there are the other counterarguments on shelf space posted... but I don't think selling our cigs is of most importance, anyway... just proof of concept in real-world, govt. mandate, then licensing or bo...
MRTP designation is the equivalent to Lights in the past... remember how Lights was misleading? I think FDA won't care if MRTP desig. on cartons is misleading (in the sense that it's healthier), because they know what it'll do for smokers - lessen cravings and help them quit.
GLTA
Thx for the 2-month old reply
If you haven't heard, FDA approved our cigs and the Surgeon General's report reflects where we're heading... as does all the alt. tobacco investments BT is making...
MRTP is next, then a real-world study, then NPRM - IMO
https://finance.yahoo.com/news/big-tobacco-future-now-114846988.html
He could also look at reshaping other aspects of Imperial’s business, including traditional cigarettes. The company is already seeking to raise up to 2 billion pounds ($2.6 billion) through disposals, including a sale of its premium cigar business. But he could go further, say selling off parts of the portfolio in Asia and Africa, and returning the proceeds to shareholders, or investing more in tobacco alternatives.
Lungs 'magically' heal damage from smoking
https://www.bbc.com/news/health-51279355
Hemp Prices Plunge as CBD Demand Falls Short
https://www.bloomberg.com/news/articles/2020-01-26/hemp-prices-plunge-as-cbd-demand-falls-short-cannabis-weekly
There we go... we'll help make this happen...
Change takes time - ever be resp. for a multi-yr plan working in a limited-resource environment? Everything is about baby steps... you'll see posters summarize steps/progress so far on stocktwits...
Did we not reach a milestone with FDA approvals on our cigs? If MRTP recommendation happens in 2 weeks, will you continue to question? Read the 2020 Surgeon General's conclusion... writing is on the wall... who the hell was talking about a tobacco endgame with VLN before? Tweeting Zeller...
Then we need a real-world study (Quarter 2?), then we need NPRM...
I'm curious to see what Panacea does with our IP... and how well they operate in an increasingly regulated CBD market... should they not have an edge?
Because the force is coming... NPRM
They also see the writing on the wall with decline of cig sales
They want MRTP for IQOS... would that be a first for heat-not-burn? FDA will make it happen for them for their cooperation...
Didn't you hear? Health nuts are the new zeitgeist... and transparency is the new thing. Smoking has been in decline... 5% per yr... their big money infl. has decreased substantially since the 60s according to data... so much so that 'smoke-free' is the new slogan... oh and why the hell is FDA tweeting about Zeller's TedTalk from March?
I think NPRM can get back unto FDA's Agenda in Spring potentially after comments review... maybe Winter after study published on VLN in real-world...
The order of operations are clear to me
Proof of concept in real-world setting first... that's what I was wrong about with believing NPRM, first
I'm not as concerned with patents expiring anyway... VLN approval/MRTP approval?/decade(s) plus in breeding ahead of competition... we have non-GMO don't forget it
I think this is why Cliff had said in his first CC... hemp/cannabis can be potentially "more lucrative" ... in near term context... if I recall correctly...
Doesn't matter to me; how awesome is it that FDA approved our cigs? None other in past 10 years...
I say we get MRTP, and so does PM's IQOS... inside dealings are happening... PM is on board w/ VLN IMO
Read the conclusion of the 2020 Surgeon General's report... there's a bullet point on the tobacco product standard to lower the level of nicotine as an endgame...
There's also:
"The most effective interventions frequently originate at the local level before percolating to higher levels and ultimately becoming recognized as evidence-based practices. Action at the federal level is a key lever to success, but such action must be complemented by..."
Supports my earlier assertion.
Both on page 660.
I stand by earlier post... we get MRTP, we begin to sell in limited market, we track data and show smoker decline rates (proof of concept), we push NPRM...
What can happen in-between with regard to share price? Anyone knows.
Those comments from Cliff and Zercher were already made... weeks ago. They're not new.
Limited distribution potentially occurring 2nd Quarter? Interesting...
1 month to go til TPSAC
CEO search? Hopefully just a ruse...
Promotion of new chairman? Maybe she did something important and negotiated the seat? Her role in her firm: "Sullivan is founder and president of Sullivan Capital Partners Inc., which provides investment banking, mergers-and-acquisitions and financial consulting services to closely-held private companies."
All speculation... but we got our cigs approved... if we can get the MRTP, and the FDA can simply say they'll watch us closely... and we show some 'real-world' progress in a limited-distribution market/locale... then, NPRM?
And why the hell is FDA tweeting out Zeller's TEDTalk from March 2019?
GLTA
Interesting how I reposted the Zeller TedTalk (from March 2019) on Jan. 4 and then a couple days later, FDA Tobacco twitter page tweets for 650k plus more views... I'm just saying!
GLTA... let's get this done.
From TPSAC, with love
#Valentine's Day
"Create the cig. of the future" < 30 seconds
https://www.ted.com/talks/mitch_zeller_the_past_present_and_future_of_nicotine_addiction
Nicotine Standards in the United States - Published: 23 December 2019
https://academic.oup.com/ntr/article/21/Supplement_1/S1/5684963#.XgIjp686p5I.twitter
This Special Issue on nicotine standards in the United States will address many of the questions raised in the Advance Notice of Proposed Rulemaking (ANPRM) through a series of policy commentaries and timely empirical studies across a variety of topic areas within the proposed comprehensive nicotine standards plan. The questions addressed in this issue include: (1) the threshold dose of nicotine (and other constituents) that would lead to minimally addictive cigarettes; (2) the effects of a nicotine product standard in smokers with co-morbidity, youth and young adult smokers, and menthol smokers; (3) a step-down or targeted data approach to reducing nicotine in cigarettes; (4) perceptions and communications about product standards; and (5) requirements associated with the implementation of a nicotine product standard.
Do you still doubt the ruling is delayed, shelby? Spring agenda is perfect timing... GLTA. Clear PMT, MRTP, then NPRM... I believe this was the order I suggested months ago, actually.
TPSAC Meeting, 2-14-2020, 22nd Century Group Inc. MRTP Applications
FDA has issued a Federal Register notice announcing a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) scheduled for Feb. 14, 2020, at FDA's White Oak Campus. The committee will discuss scientific issues related to the modified risk tobacco product (MRTP) applications submitted by 22nd Century Group Inc. for VLN TM King and VLN TM Menthol King combusted, filtered cigarettes, which are currently under scientific review by FDA. These products recently received marketing authorization under the names Moonlight® and Moonlight® Menthol.
Please refer to the Federal Register notice for instructions on how to submit public comments related to TPSAC. Requests to present an oral comment at the February 2020 meeting must be received by Jan. 30, 2020. Written comments related to the TPSAC meeting must be received by Feb. 7, 2020.
These deadlines apply only to the TPSAC meeting and do not apply to the public docket for 22nd Century Group Inc.’s MRTP applications. There is currently no deadline for public comments on these applications.
Can we put this in bold, please? :)
TPSAC Meeting in February 2020 to Discuss 22nd Century Group Inc. MRTP Applications
FDA has issued a Federal Register notice announcing a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) scheduled for Feb. 14, 2020, at FDA's White Oak Campus. The committee will discuss scientific issues related to the modified risk tobacco product (MRTP) applications submitted by 22nd Century Group Inc. for VLN TM King and VLN TM Menthol King combusted, filtered cigarettes, which are currently under scientific review by FDA. These products recently received marketing authorization under the names Moonlight® and Moonlight® Menthol.
Please refer to the Federal Register notice for instructions on how to submit public comments related to TPSAC. Requests to present an oral comment at the February 2020 meeting must be received by Jan. 30, 2020. Written comments related to the TPSAC meeting must be received by Feb. 7, 2020.
These deadlines apply only to the TPSAC meeting and do not apply to the public docket for 22nd Century Group Inc.’s MRTP applications. There is currently no deadline for public comments on these applications.
Let's do this
Hopefully it's 'VLN' that'll be labeled on cig boxes hence the name change during application review...
PM is on our side, I believe... 'smoke-free' future... it's a dying business anyway, let's get behind a healthier product and revamp our image in the eyes of new generations to come...
Never the intention of CF to stay past a few months but to get the ball rolling... something political needed to happen or he was just jumping in (after playing consultant) because HS really did need to step down, IMO... anyone's guess what that was, but he played his part in the drama...
The naysayers can't contest with at least one thing: FDA finally approved our product... 10 years, no one else. Hmm...
Yes - VLN cigs are essentially a 'scaffold' in education lingo... it can be the first scaffold when attempting to quit, as it still involves smoking a cig... as one author in an article noted, the motivation to choose VLN over not may be a challenge... hence the need for NPRM...
But like you say - for those with will power to choose Chantix, gums, vapes, why not combine for a short time with VLN?
Let's see what happens... anything possible - much more exciting times than a week earlier... all coming to fruition, one way or another... we're there as a society - goodbye BT power, hello health-nuts and life longevity...
I'm also wondering if, at the time, Moonlight was non-GMO... we've got several varieties and types, now...
FDA (a US institution, of course) banned the word lights, etc. correct? So, for the US, being permitted the name Moonlight may still hold significance? Time will tell.
FORBES - Low-Nicotine Cigarettes? The FDA’s Recent Ruling
https://www.forbes.com/sites/danadovey/2019/12/20/low-nicotine-cigarettes-the-fdas-recent-ruling/#4a969a7e20b8
“I don’t know if having both [traditional and reduced nicotine] cigarettes available at the same time would really help,” says Karelitz. “Smokers really need to be internally motivated to seek out these [low-nicotine] cigarettes and continue using them despite probably not liking them as much as their own brand.” Mandating all cigarettes to have a lower nicotine content could help wean American smokers off of their habit, he argues.
Got it - thanks.
Logical argument?
Congo/Magpi get full credit - I'm summarizing:
1. In order to comply with a 2006 court ruling in United States v. Philip Morris USA, Inc., et al.,[16] Philip Morris (and all other cigarette companies) is now prevented from using words such as "Lights", "Ultra-Lights", "Medium", "Mild", or any similar designation that may yield an impression of being safer than regular full flavored cigarettes. Thus Marlboro and other cigarette companies use only color-coding instead; for example, Marlboro Lights are now called Marlboro Gold Pack.
2. Our cigs were renamed from VLN, to MoonLight during the application review... that we're even allowed the word light, is HUGE considering its ban in 2006
3. The end game of XXII has always been to license its tech/seeds to big tobacco... could it be that big tobacco could use the word "light" in some way if they willingly adopt our cigs?
4. That we're even allowed the word light implies we get the MRTP app. approved, too
5. I'll add, in case Trump doesn't get reelected and then Hahn/Azar are removed from posts, they'll see this through before November...
This stock will go to $20+ within the year
? Elaborate please
Uh huh - maybe. But, I do wonder why no CEO replacement or talk of searching for one...
There is NO smoking compensation for nicotine when switching to VLN... there's a clinical study for that. This is a common misconception. We need to educate this point to the public.
https://www.xxiicentury.com/published-clinical-studies/
17. Phase I – 26 Subjects
Response to varying the nicotine content of cigarettes in vulnerable populations: an initial experimental examination of acute effects
University of Vermont Center on Tobacco Regulatory Science
Higgins et al. – October 2016, Psychopharmacology. DOI: 10.1007/s00213-016-4438-z
There was no evidence of compensatory smoking with VLNC cigarettes in these vulnerable populations and there were significant reductions in nicotine withdrawal and cravings with VLNC cigarettes
These initial results in more vulnerable populations of smokers are encouraging regarding the feasibility of a national policy to reduce the nicotine content of cigarettes to very low levels without substantial adverse effects
Funded by a Tobacco Centers of Regulatory Science (TCORS) award (P50DA036114) from the National Institute on Drug Abuse and Food and Drug Administration
Copenhagen Snuff just got a deadline for closing comments on MRTP... we next? Hahn/Zeller making moves.
Do you remember the argument about BAT 'breaking up' with XXII? Feels like a long time ago... we had nothing of value, remember?
One more time: Lol
Everything is coming to fruition. Maybe not as anticipated - starting - with the NPRM, but through a backdoor. Perhaps - get it on the market, prove its worth, get MRTP, then have a case for NPRM. By this time, vaping/mjna will be regulated to a degree where BT's businesses will be sustainable/tax dollars make politicians happy/etc.
Hopefully we don't have to prove our worth in the real-world and we just get the damn MRTP.
GLTA
Good :)
Longrun's second post in the last three years was: "Would you please stop crying...You remind me of my little brother."
hahahahaha
That's awesome.
Simple, I don't mean to be facetious: with this approval, anything is possible now. Prior to approval, only approval was possible.