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So we know that Phillip Morris spent $300 million trying to do what 22nd Century does, if they spent $300 million to buy the IP/company that would put us at approx $7.00 per share. Can we say this is truly undervalued?!?!?
If the FDA regulates nicotine levels below what others can produce then 22nd Century would have the monopoly on the market, what would that be worth for a PPS in a $800 billion market, blows the mind that this is trading at .62!!
It's genius!! Smoking 34 years and have tried every product on the market to quit including these new e cigs that are terrible! Can't wait for these products to hit the market!
"Who'd a think a cigarette would be the "drug" that gets people to quit."
Thanks for the response Van, the potential here is truly amazing and with the low float it should keep the heart pumping, lol. I'll be pulling for this company in more ways then one!
Thanks Van, I understand that but don't they have to get FDA approval here in the states? Are they in trials now or am I misunderstanding this, thanks? Being a smoker for 34 years I need this product available here soon! :)
Does anyone know what the timeframe of the phase 2B trial? Thanks
This morning, 22nd Century Group, Inc. (OTCBB:XXII) announced progress towards commercialization of their prescription smoking cessation aid in development, X-22. The Company has filed an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the proprietary very low nicotine cigarettes and protocol as a stop smoking aid. Additionally, 22nd Century Group has requested that the FDA grant “Fast Track” designation to X-22. “Fast Track” is an expedited regulatory review of drugs undergoing clinical trials that treat serious or life threatening diseases and that demonstrate the potential to address unmet medical needs.
Through its exclusive technology, 22nd Century alters the level of nicotine (and other nicotinic alkaloids) in the tobacco plant to be decreased or increased through genetic engineering and breeding. In the case of X-22 cigarettes, the nicotine levels are roughly that of a common tomato (0.3 grams), representing 97% less nicotine than Marlboro® Gold (formerly Marlboro Lights®), the most commonly smoked brand in the U.S.
Immediately upon FDA clearance of the IND, 216 smokers will be enrolled in a multicenter Phase II-B clinical trial. The X-22 therapy protocol allows patients to smoke X-22 cigarettes without restriction over the 6-week treatment period to facilitate the goal of quitting by the end of 6 weeks. Primary endpoint results of the study – four weeks of continuous abstinence from smoking – are expected to be available this November. Quit rates of patients using X-22 cigarettes will be compared to those using an active control, cigarettes with conventional nicotine content.
Joseph Pandolfino, 22nd Century’s Chief Executive Officer, stated,
“There is clearly a large unmet medical need on a global scale for an effective, non-addictive, user-friendly smoking cessation product—without serious side effects. 22nd Century passionately believes X-22 is that product. The company is confident that the vast majority of smokers desiring to quit smoking would be willing to try X-22.”
Prior research through independent studies, including successful Phase II clinical trials, have demonstrated that VLN cigarettes made from 22nd Century’s proprietary tobacco facilitate quitting by satisfying smokers’ cravings for cigarettes while,
• greatly reducing nicotine exposure and nicotine dependence; and
• separating the act of smoking from the rapid delivery of nicotine.
An independent Phase II trial of considerable interest was conducted by Dr. Dorothy Hatsukami, Director of the National Transdisciplinary Tobacco Use Research Center at the University of Minnesota Masonic Comprehensive Cancer Center and one of the nine voting members of the 12-person Tobacco Products Scientific Advisory Committee (TPSAC) at FDA’s Center for Tobacco Products. The research compared the quitting efficacy of a VLN cigarette (containing 22nd Century’s VLN tobacco), an FDA-approved 4-mg nicotine lozenge, and a low nicotine cigarette (containing 30% of the nicotine of a typical cigarette) in a total of 167 patients treated for 6 weeks.
Point-prevalence abstinence at 6 weeks after the end of treatment was:
• 47% for the group using the VLN cigarette
• 37% for the nicotine lozenge group
• 23% for the low nicotine cigarette group (p=.0357)
Furthermore, the VLN cigarette was associated with greater relief of withdrawal from usual brand cigarettes than the nicotine lozenge. Unlike the low nicotine cigarette, the VLN cigarette was not associated with compensatory smoking behaviors. By the end of the 6-week treatment period, patients in the VLN group (whether they quit or not) on average were smoking 12 VLN cigarettes per day, compared to a baseline of 19 cigarettes per day of their usual brand. The protocol of 22nd Century’s upcoming Phase II-B clinical trial is similar to that of the University of Minnesota trial.
Mr. Pandolfino stated,
“Smokers have limited pharmacological choices for quitting: (i) nicotine in different forms, otherwise known as nicotine replacement therapy (NRT), (ii) Chantix® and (iii) Zyban®. Approximately 50% of U.S. smokers have already failed to quit with NRT and some users become addicted to NRT products. Both Chantix® and Zyban® were required by the FDA on July 1, 2009 to add boxed warnings to their package inserts.”
These warnings highlight that serious neuropsychiatric events, including but not limited to depression, suicidal ideation, suicide attempt and completed suicide, have been reported in patients taking Chantix® and Zyban®. (Chantix® is known as Champix® outside the U.S.)
According to the Centers for Disease Control and Prevention (CDC):
• Cigarette smoking is the leading cause of preventable morbidity and mortality in the United States.
• Approximately 440,000 premature deaths annually.
• Out of 46 million American smokers, approximately 20 million make a serious attempt to quit smoking every year.
• On average, it takes smokers 8 to 11 quit attempts before achieving long-term success.
• Less than 5% of smokers in the U.S. permanently quit smoking each year.
With the float being this low it doesn't take much to drop or go up. ONVO has gone through the same things with warrants, now trading in the $3.00's and their not even close to making money. The right news and this will be back over a $1.00 for good imo!
Just doing some DD, I don't have the answers to why the stock is at .60. I will admit I'm buying the .60's!
Can see why the float is so low!
Name of Beneficial Owner Number of
Shares
Beneficially
Owned Percent of Class
Beneficially Owned (1)
Management & Directors
Joseph Pandolfino (2) 7,880,109 19.6 %
Henry Sicignano III (3) 6,170,673 15.8 %
Michael R. Moynihan, Ph.D. (4) 1,631,657 4.2 %
Joseph Alexander Dunn, Ph.D.(5) 251,500 *
James W. Cornell (6) 251,500 *
All directors and executive officers as a group (5 persons) (2)-(6) 16,059,602 38.1 %
Other 5% Owners
Clearwater Partners, LLC (7) 5,265,941 13.3 %
Angelo J. Tomasello (8) 4,542,491 11.5 %
Sabby Volatility Warrant Master Fund, Ltd. (9) 2,500,000 6.1 %
Sabby Heathcare Volatility Master Fund, Ltd. (10) 4,203,858 9.9 %
(1) Based on 38,259,362 shares of common stock issued and outstanding (including outstanding restricted stock), as of March 7, 2013.
Holdings
Total Number of Shares Held 22,547,646
Large Block Owners 10
Percent Shares Owned 58.70%
Percent Change in Ownership 1.12%
Name Shares Held Position Value % of Total
Holdings Outstanding
Shares Owned Investment Style
BRODFUEHRER JOHN T 100.0 K $74.0 K 0.44 0.30% N/A
Clearwater Partners, L.L.C. 3.9 M $3.6 M 17.32 14.51% Low
Cornell (James W) 110.0 K $100.1 K 0.49 0.41% Moderate
Dunn (Joseph Alexander) 110.0 K $100.1 K 0.49 0.41% Moderate
Moynihan (Michael Robert) 1.0 M $901.1 K 4.54 3.68% Low
Pandolfino (Joseph) 5.9 M $5.3 M 26.06 21.84% Low
Rider (C Anthony) 197.5 K $118.5 K 0.88 0.48% Low
Sabby Management, LLC 3.1 M $2.7 M 13.87 11.12% High Sicignano (Henry III) 4.8 M $4.4 M 21.27 17.82% Low
Tomasello (Angelo J) 3.3 M $3.0 M 14.64 12.27% Low
Well, I couldn't wait any longer took a starter position today, hoping that I'm not catching the falling knife here but I like the long term potential. GLTA
Holy smokes, this must have a low float, .19 gap on 33k shares, wow! Can't seem to find the utd o/s's and float, does anyone know? TIA
Great, thanks John!!
Hey John, newbie to the board and stock, bought a boat load last week, wishing I had waited!! Looking for your thoughts on the chart? TIA
They put up a wall at .22, the good news is no one is selling under!
Anyway to get a copy of your report? TIA
Thanks Van, I'm always alittle late to the party :) What's the best way to get a copy of that issue, sorry don't have PM? Thanks again
Hi Van, this stock just came on my radar, saw that you posted the other day. Are you on BKYI? Started my DD any advice on where to find some good information regarding the patents, etc? Chart looks great and they could be a big player in a potential large market, any thoughts! Thanks
Absolutely, I apologize for being the real moron and taking your post personal. I appreciate your post. I know we both want the same things here. Love the moron penalty box reference, classic!
There's no doubt Brooklyn is short it is as clear as day and has been from day one. The best way to handle these people is to ignore as my fellow long streamingeagle has stated. Right now they can talk about the past and the lack of revenue but it doesn't matter at all, what matters is what happens going foward with Destiny's new technologies, period. It's going to be a interesting year!
Just listened to the call and yes Steve was shocked there was no more questions. Sounds like Steve is always available for questions and the caller covered just about everything. Over a excellent call, now we wait!
Hey Brooklyn, how is the CC going?
Completely agree, still a lot of work to do but it seems things are improving weekly. Would love to see a perfect product soon!
I have to center the video with the phone, but when center played great on my ihone 4, much better then my laptop!
Is it doing that on your computer, tablet or phone?
Every video plays perfectly on my iphone and kindle fire! Very encouraging!!
Looks like we may have busted through the ask at .79 now .82!
Your a very demanding person, just another moron hiding behind their keyboard, stay focused on the prize, not my post!
I get the same thing on my laptop, just with the new MPE vids. About 1/2 inch space at the bottom in full screen.
Thanks for the stage! I feel special now. You will be hard pressed to find any of my posts bitching and moaning. When you reply to someone know what you are talking about!
Yes sir, lol
...lighten up man its a open forum, we can bitch, complain and argue all day long.
I emailed the paid pumper line and they claim there is NO paid pumper here.
Can anyone tell that Destiny is starting to make these shorts very nervous? The smell of fear is in the air!! The sign of more good things to come!
lmao, you emailed the company and they said no...you must be losing your ass here because now your getting desperate...classic!
I wonder if Destiny is involved in this potential deal, got this from a Raging Bull post, very interesting!
Deals are apparently pending with Universal Music Group and Warner Music, according to CNET, and Apple is pushing for a summer launch. Apple's streaming music service will launch first in the U.S., and the company is planning on expanding into the U.K., Japan, Australia, France, and Germany shortly thereafter.
http://www.macobserver.com/tmo/article/apple-closing-in-on-streaming-music-deal
If someone is a paid pumper on this board, where do I sign up. There's like 30 people either posting or reading this board, zero on yahoo..lol....this pumper you claim should not be getting paid. Contracts and revenues will move this stock not any paid pumper on ihub. Classic!!
After a few more contract announcements, big money will eat up the rest of the float and then we are off to the races. The key for us team members, stay patient and keep accumulating shares! :)
Excellent explanation Van!
You started your own post, "This new deal", yes it is a new deal but any deal with a company Universal is a great deal imo!!! It validates and opens many of possibilities!! Very good news!
Exactly, keep the contracts coming in and this short position will evently go away. They sure are providing us with great buying opportunities knowing that the future looks great for Destiny and shareholders!
I saw that on etrade, they are back. I'm sure the dead guy wasn't alone and yes they are still working it hard.
Thanks
Thanks dd, I'm not getting good service on this wireless network.
Hey dd, just did the speed check on the Destiny link, my numbers are download 3.52 and upload is 1.33 are these number good or bad, thanks! I truly have no clue.