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Clinical Study Info
I was trying to piece together comprehensive data out of the articles being put out recently, most of which seemed (to me) lacking bits of information. Anyway, scrunching about the web I compiled the below info and time lines.
ClinicalTrials.gov Identifier: NCT01681875
First received: August 30, 2012
Last updated: September 17, 2014
Last verified: September 2014
Study Status: This study has been completed.
Study Completion Date: July 2014
This appears to be the study that made it into the NEJM on 10/1/15
http://www.nejm.org/doi/full/10.1056/NEJMsa1502403#t=articleResults
In the last paragraph, in part, under “Discussion”
“If confirmed in longer-term studies, these findings suggest that, when combined with other tobacco-control policies (e.g., taxation and expanded access to treatment), limiting the nicotine content of cigarettes in order to reduce cigarette use and nicotine dependence and facilitate efforts to quit smoking could improve public health.”
“A longer trial is currently under way (ClinicalTrials.gov number, NCT02139930) “
-------------------------------------
From: ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT02139930
First received: May 12, 2014
Last updated: May 26, 2015
This was added 5-12-15: Grant/Contract Award
Last verified: May 2015
This study is currently recruiting participants.
Verified May 2015 by University of Pittsburgh
Sponsor: University of Pittsburgh
Collaborator: National Institute on Drug Abuse (NIDA)
Estimated Enrollment: 1250
Study Start Date: September 2014
Estimated Study Completion Date: August 2016
"The main goal of this project is to compare two different approaches to reducing levels of nicotine in cigarettes: an immediate reduction in nicotine content in cigarettes to non-addictive levels or a gradual reduction in nicotine content in cigarettes to non-addictive levels. These two approaches will then be contrasted to a group that continues to smoke cigarettes with nicotine content similar to conventional cigarettes."
Listed as “Arms”
Active Comparator: Normal Nicotine Control Group
These subject will smoke normal nicotine content Spectrum brand cigarettes for 20 weeks.
Experimental: Immediate Nicotine Reduction Group
This group will immediately be switched to smoking very low nicotine content (VLNC) Spectrum brand cigarettes. They will smoke these cigarettes for 20 weeks.
Experimental: Gradual Nicotine Reduction Group
This group will smoke progressively lower nicotine content Spectrum brand cigarettes for a period of one month each until the end up smoking the same VLNC cigarettes as the immediate reduction group.
--------------------------------
“September 1, 2015….22nd Century Group, Inc., announced today that its wholly-owned subsidiary, Goodrich Tobacco Company, received a purchase order for 4.95 million SPECTRUM U.S. government research cigarettes.”
--------------------------------
Not stated,but seems that this would fit in for ClinicalTrials.gov Identifier: NCT02139930
Comments ?
BAT aligned with XXII
BAT is aligned with XXII but is also aligned with BUCKS.
British American Tobacco
E-cigarettes
A growing market with huge potential
We place great strategic importance on our work in this area of tobacco harm reduction. Our intention is to be a leader in these new product categories.
We have the expertise to deliver superior quality next generation products, we are committed to sustainable growth and we’ve got the ambition to lead.
In 2013, we were the first international tobacco company to launch an e-cigarette, Vype, in the UK. Since then, we have further increased our understanding of the needs of consumers in this sector.
In 2014, we used these insights to develop the range. We launched two new innovative products to better meet consumer expectations – Vype eStick and Vype ePen.
We launched the Vype eTank in July 2015 – a refillable e-cigarette which gives users control over the nicotine strength and flavour combinations that suit them.
We also launched a range of Vype eLiquid flavours, in a variety of nicotine strengths. Our eLiquids are made to the highest quality standards and manufactured in Italy and the UK. The nicotine in them is pharmaceutical grade, so also of the highest of quality.
We will continue investing substantially in the research, development and commercialisation of a pipeline of products. We will also use the insights from our experience in the UK to support Vype’s launch in further markets.
At British American Tobacco, we understand all the different elements of what smokers like about the experience they get from cigarettes. This means we can better meet the needs of those smokers who are seeking an alternative to cigarettes.
If we are successful in developing and bringing to market a range of products that meet the needs of adult smokers seeking safer alternatives to cigarettes, this will help to meet the objectives of a number of leading public health professionals.
And of course it will also make commercial business sense to us and our shareholders.
Entire article http://www.bat.com/ecigarettes
*******************
From my post #27397
Tobacco companies such as Philip Morris International and British American Tobacco have viewed e-cigarettes as a solution to declining sales in Britain and the United States and have bought makers of the metal devices.
Calling the study (My post #27396) an "incredibly important milestone", a British American Tobacco spokesman acknowledged the risk posed by chemicals found in cigarette smoke and said increasing sales of e-cigarettes would greatly benefit their customers' health.
Chart reading question...
Looking at todays XXII chart at etrade,
it shows a buy (green bar) of 22.600 shares at 12:20pm.
Anyone have a possible reason why the share price didn’t move?
At 1:28pm a 10K trade raised the the share price from .89 to .90
Chardan Special Equities Group
Customized Services for Micro-Cap Companies and Investors
Chardan’s Special Equities Group (SEG) provides specialized investment banking and brokerage services for micro-cap companies and their investors. A recognized leader in the PIPEs market, the group has collectively closed more than 70 transactions and raised in excess over $650 million since 20081 in emerging growth capital.
Our clients
The Special Equities Group focuses on U.S.-listed micro-cap companies. The companies we work with look to us for strategic advice and, when they need funding, rely on our ability to quickly and efficiently raise capital on their behalf.
Our investors
We seek to cultivate long-term, strategic relationships with our investors. They trust us to provide honest advice and objective evaluations of investment opportunities.
Our reputation for integrity allows us to maintain an extensive base of institutional investors, hedge funds, and high net worth individuals.
Capabilities
Capital Raising
• PIPEs
• Registered directs
• Secondary offerings
• Private placements
Advisory Services
• 10(b)-5-1 sales plans
• Mergers & acquisitions
• Corporate and executive services
• Warrant exchanges
• Board development
• IPOs (Initial Public Offerings)
• CMPOs (Confidentially Marketed Public Offerings)
http://www.chardancm.com/companies/special-equities-group
48,000 shares traded today.
Some individuals here hold more than that....
Last time lower than 48k was Jan 6, 2014
Been wondering.....
What are some of the possible outcomes if the Pando case goes in favor of XXII?
In the past I’ve seen the sale of 100k of shares knock XXII share value down 10%.
I sure don’t believe he could be fined $5 mil worth of XXII shares.
Could his share volume be diminished?
Could controls be established for sales of his shares?
Anyone have thoughts of reasonable possible outcomes in this case?
Traders take the day off?
Looks to be on track for the Lowest Volume day of the year.
(March 2nd 71,700 shares traded).
And congrats to you.......
And congrats to you for being savvy enough to follow this Group to be able to recommend this stock to others.
Read more of our thoughts on our pick, XXII, (up 66% in the past two weeks; in a bear market) right here:
http://investorshub.advfn.com/22nd-Century-Group-XXII-21680/
Long over-due move....
Nice 4 day chart. .60 to .80 = 33% up.
Hopefully a longer term momentum builder.
E Cigarettes: Article...
Electronic cigarettes are around 95 percent less harmful than tobacco and should be promoted as a tool to help smokers quit, a study by an agency of Britain's Department of Health said on Wednesday.
E-cigarettes, tobacco-free devices people use to inhale nicotine-laced vapor, have surged in popularity on both sides of the Atlantic but health organizations have so far been wary of advocating them as a safer alternative to tobacco and governments from California to India have tried to introduce bills to regulate their use more strictly.
"E-cigarettes are not completely risk free but when compared to smoking, evidence shows they carry just a fraction of the harm," said Professor Kevin Fenton from Public Health England, which carried out the study.
Most of the chemicals that cause smoking-related diseases are absent in e-cigarettes and the current best estimate is that e-cigarette use is around 95 percent less harmful to health than smoking, the study said.
Passive inhalation from an e-cigarette was also much less harmful.
The publicly-funded study goes against a 2014 report by the World Health Organization that called for stiff regulation of e-cigarettes and bans on their indoor use and sale to minors.
It also contradicts the finding of another study by researchers from the University of Southern California which said this week that U.S. teens who tried electronic cigarettes might be more than twice as likely to move on to smoking conventional cigarettes as those who have never tried the devices.
The Public Health England study said e-cigarettes, which are already the most popular quitting aids in Britain and the United States, could be a cheap way to reduce smoking in deprived areas where there remains a high proportion of smokers.
It criticized media campaigns that have called e-cigarettes equally or even more harmful than smoking that could serve as a "gateway" to tobacco cigarettes among teenagers.
"There is no evidence that e-cigarettes are undermining England's falling smoking rates," said Professor Ann McNeil who helped author the study.
"Instead the evidence consistently finds that e-cigarettes are another tool for stopping smoking and in my view smokers should try vaping, and vapers should stop smoking entirely," she added.
Almost all of the 2.6 million adults using e-cigarettes in Britain are current or ex-smokers who are using the devices to help them quit and only 2 percent of young people are regular users, the study said.
Tobacco companies such as Philip Morris International and British American Tobacco have viewed e-cigarettes as a solution to declining sales in Britain and the United States and have bought makers of the metal devices.
Calling the study an "incredibly important milestone",
a British American Tobacco spokesman acknowledged the risk posed by chemicals found in cigarette smoke and said increasing sales of e-cigarettes would greatly benefit their customers' health.
http://www.reuters.com/article/2015/08/18/us-health-britain-ecigarettes-idUSKCN0QN2AC20150818
E Cigarettes: Britain's Department of Health…
The below article appeared in the New York Times and also was in today’s Buffalo News edition.
British health officials on Wednesday reported the results of a government-funded study concluding that the use of electronic cigarettes can reduce the health risks of smoking by 95 percent and may also help smokers quit the habit.
The study, issued by the government agency Public Health England, also found little evidence that consumers who had never smoked before were adopting e-cigarettes in large numbers. Some researchers expressed concerns that young people would use the devices as a gateway to regular smoking.
It also said that any new regulations adopted in Britain should emphasize the device’s public health benefits.
The new report emphasized that e-cigarette use was not free of risks. But its findings may accelerate the use of electronic cigarettes in Britain. It also could affect a public debate in the United States over whether the devices represent a breakthrough in reducing the death toll exacted by cigarettes or a new vehicle to addict consumers to nicotine.
It has long been known that cancer-causing substances associated with cigarette smoking are released when tobacco burns — something that does not happen with an e-cigarette.
Nonetheless, some experts have argued that the vapor-heating process used in e-cigarettes may also produce carcinogens, and that smokers should be encouraged to stop smoking, rather than use alternative nicotine delivery systems.
In recent years, the Food and Drug Administration has worked to develop new regulations for e-cigarettes but has yet to complete them. While the designs of e-cigarettes vary, most devices heat a nicotine-containing fluid to create a vapor that users inhale.
The new report is the latest in a series of studies issued in recent years by British officials that have examined an evolving body of scientific data about e-cigarettes.
One of the study’s underlying aims was to clarify the public debate over e-cigarettes, Duncan Selbie, the chief executive of Public Health England, wrote in a foreword to the report.
“Many people think the risks of e-cigarettes are the same as smoking tobacco and this report clarifies the truth of this,” Mr. Selbie wrote. “In a nutshell, best estimates show that e-cigarettes are 95 percent less harmful to your health.”
Dr. Neal L. Benowitz, a professor at the University of California, San Francisco, said that British researchers had been more optimistic than some of their American counterparts about the potential of e-cigarettes. But he said that there was still a lack of compelling evidence to demonstrate how the devices could best be used to help smokers quit.
In the report, the agency encouraged regulators to view e-cigarettes as a low-cost means to reduce smoking in poor populations, where it is prevalent.
http://www.nytimes.com/2015/08/20/business/british-study-says-electronic-cigarettes-curb-smoking-risks.html
Welcome back to XXII, Ms. scott.
Stick around, we could use a bit of a rally.
Sorry about your other stock prognostications also.
----------------------------------------------------------
fredscott36 Monday, 07/06/15 10:20
Post # 34212 (in part)
http://investorshub.advfn.com/United-Western-Bancorp-Inc(fkaUWBKQ-18247/
...f. scott's predictions have missed...........MIGHTILY........admitted............
...quite a few other prognostications which have not materialized..........comes now, fred q. scott does hereby and wherefore beg for mercy and forgiveness...................and ms. scott promises to sin no more and to repent with diligence.......
...so, JACKBOOTS, wtf do I know...........??????........
---------------
Don’t feel bad. It’s tough out there.
Save your above post. You’ll need it down the road to post right here for XXII.
And, your XXII posts are telling as to “what you know”. ???
Have a nice day, Ms Scott.
Daily volume....
Monday’s & Tuesday’s XXII daily volume
were the lowest since mid April.
136,600 and 156,400.
Is the Russell rebalancing still going on?
If I’m reading the volume chart properly,
Yesterday 125k and today 250k shares were dumped,
both days around the noon hour.
Is this what others see?
Two hour Sell off......
Anyone know who’s been dumping since 2pm?
Is this a piece of the Russell redo?
Thought's, Ideas?
At least a break in the 3.5 month trend……
Settlement Date / Short Interest
5/29/2015 / 3,313,865
5/15/2015 / 2,885,126
4/30/2015 / 2,445,049
4/15/2015 / 2,201,040
3/31/2015 / 2,086,582
3/13/2015 / 1,909,149
2/27/2015 / 1,867,668
Added here at $1.01
Future stock predictions........
According to hatexxii’s post on another iHub stock Forum yesterday, he says he used his “crystal ball” to make his futuristic predictions.
That one was wrong also. Nada. Zilch.
Buy high, sell low. LOL
Unreal.........
Bottom ?
The weekly close for the last four weeks has been $1.07 – $1.08.
Hopefully a bottom is being established.
JP insider trading...
All the info I see indicates the only recent insider trading was by Joseph Pandolfino.
He sold 343,133 shares through out the month of December 2014.
This was his only selling during the past 12 months.
JP’s trading ability may also be restricted with pending court case.
Also,
SF Branded cigs didn't became exclusively manufactured & shipped by NASCO till March 31, 2015.
Pack or Carton per second
Z, Please check out the video at the 1:28 minute mark.
https://www.dropbox.com/s/v1sfdejt978jh0p/XXII_Century_RedSun_Production.MOV?dl=0
One CARTON per second.
A carton per second off that line.
Thanks for sharing the video.
The Street
The financial aspect of The Street’s report seems in itself accurate.
Sure does beat the old “Alpha”(?) original posting.
Anyone looking to invest would be turned off by these numbers.
No mention of XXII finally getting the distribution of new products out the door, new marketing areas and their potential impact on revenues, etc.
This time the numbers don’t tell the whole story....
Spain / U.S. cigs ....
It does kind of baffle me that we get a contract to produce the SF brand cigs for the 800 shops here, but XXII didn’t contractually include the right to be able to put up at least a single display of Red Sun in each of those shops.
I sure hope the 900 shops in Spain don’t have to be asked for the stocking of Magic cigs by the individual cig buyers as they have to do in the U.S. for a pack of Red Sun at a SF shop.
We will see....
SF shops
Each Smoker Friendly retailer is independently owned and operated.
It appears that no agreement between SF & XXII to have our smokes mandated for sale at the SF shops.
Up to individual SF owners to determine what brands they will sell.
Just received my daily mail.
Included was a 7”x 10” bubble wrapped package from XXII.
Besides a proxy card, there was a pack of Red Sun !
Upon opening the pack I saw that the individual cigs were only filled with filter material end to end.
Bummer...
Letter included states a “specimen” pack (no Tobacco) because of Fed regulation.
Alternative Brews is about 10 miles from XXII main office.
Heavy New York state tax in the price.
Two locations listed in NY.
Manhattan & the other about 10 miles
from XXII’s Clarence office.
Alternative Brews Inc
3488 Sheridan Drive, Amherst, NY
(716) 446-0424
P & D
“Pump & Dump” completed.
Hope no one here received additional “pain”.
Compensation increase vote on agenda
In 2014 the Five Executive Officers of XXII were paid $3.87 mil in total compensation.
5 mil in revenues expected this year.
http://www.sec.gov/Archives/edgar/data/1347858/000114420415014566/v403764_def14a.htm
Does this amount of payment seem appropriate for a company in our current position of growth and income ?
Seems high , but I have no idea... hence the question.
Anyone ?
Jump in SP,
Well, were back to a level of where we were 4 weeks ago.
Feels good to break the downward spiral.
50% rise in a couple of days can’t be because of the added title to our leader.
Good news coming?
Hoping this move isn’t just a reaction to BP Rising’s post and to be followed up by a dump.
Forward and upward......
11-25-14 Chardan conference call –
“We expect that our contract begins in January and as we gain regulatory approval in each state -- meaning after we get Smoker Friendly products registered on the state directories of approved products, then we will begin shipping Smoker Friendly product.”
Beginning April 1st, besides supplying Red Sun, we will be assuming sole rights to manufacture and ship the “SF” private label (11 brand styles) cigarettes .
”Smoker Friendly is a MSA product - NAAG has to approve the SF agreement before shipping can begin.
Expect shipping 6 weeks after NAG has approved agreement”.
We’re shipping.....
Train ride
Not the prognosticating type, but feel the best in months about this stock.
The steepness of the grade the train has in its path forward, has been lessened greatly.
$$ will be coming in, and time will be gained to pursue our other ventures.
Three months ago, when these announcements were originally scheduled to be initiated, XXII was @ $2.22.
Blunders ensued. Three months of production time, revenue $$, etc, all down the tube. 50% SP also gone.
These past two significant PR’s continue XXII plan and fit Henry’s previous guidance.
I have been long term and will continue to be. First have to get that 50% back .
Hoping for a steady increase in SP when revenues start in.
The game changer of course is getting one of our patents into production.
Bub
I also have taken the “hit”.
Up until 2 weeks ago we had nothing to make a buck with.
Our facilities are now producing a product, earnings.
SF brand sales are contracted $$, and Red Sun cigs at their stores (sales $$ unknown).
At least seems like a great starting point to me.
No dreamer here, But the train has finally left the station.
Bub
Shipping cigs to SF !
That’s the PR I’ve been waiting on.
I thought it was appropriate to be included in last weeks other shipping PR.
Made me sweat out a week but worth the wait.
To me this is the news that carries XXII forward.
All the other options for the company can be worked on as we bring in $$$.
Bub
Looking through the past conference calls, this may be the the reason for the omission of SF from the shipping announcement:
From the Summary of XXII Conference Call Nov. 25, 2014
”Smoker Friendly is a MSA product - NAAG has to approve the SF agreement before shipping can begin.
Expect shipping 6 weeks after NAG has approved agreement”.
If not approved yet, no shipping to them.
Don’t know how far through the process that approval is, but could be my answer.
Red Sun sales
There is no reference to SF in yesterdays news release.
That’s my point.
It just appears to me were going forward without Smoker Friendly.
Nothing about stocking SF shelves with our product.
This is a “Repost” Looking for comments...
Red Sun sales
“RED SUN is initially being offered to independent distributors and specialty retailers located in select markets such as New York City, Los Angeles, San Diego, Las Vegas, Boulder and Portland.”
Todays announcement is looking a touch odd to me.
We have a few cities listed where our cig’s will be available.
No mention of Smoker Friendly shops, anywhere.
I’m wondering who are the retailers involved?
From the SF website, “Find Store Near You”
http://smokerfriendly.com/store-locations/
In NYC: 5 stores on Long Island, 1 in New Rochelle
Los Angeles: Nearest SF store 250 miles north
Las Vegas: Nearest SF 135 miles away in Arizona
Boulder: 1 store
Portland: 3 stores within 15 miles
San Diego: none
Anyone else get these same results?
Why aren’t we starting out with the SF shops as originally planned?
Hope we still have our contract with SF to produce the SF branded smokes and introduce Red Sun in their stores.
Might explain todays SP if not.
Thoughts???
Bub
Red Sun sales
“RED SUN is initially being offered to independent distributors and specialty retailers located in select markets such as New York City, Los Angeles, San Diego, Las Vegas, Boulder and Portland.”
Todays announcement is looking a touch odd to me.
We have a few cities listed where our cig’s will be available.
No mention of Smoker Friendly shops, anywhere.
I’m wondering who are the retailers involved?
From the SF website, “Find Store Near You”
http://smokerfriendly.com/store-locations/
In NYC: 5 stores on Long Island, 1 in New Rochelle
Los Angeles: Nearest SF store 250 miles north
Las Vegas: Nearest SF 135 miles away in Arizona
Boulder: 1 store
Portland: 3 stores within 15 miles
San Diego: none
Anyone else get these same results?
Why aren’t we starting out with the SF shops as originally planned?
Hope we still have our contract with SF to produce the SF branded smokes and introduce Red Sun in their stores.....
Thoughts???
Bub