22nd Century Statement on FDA Nicotine Reduction Plan

22nd Century Group, Inc. (NYSE: XXII) today called attention to comments submitted to the U.S. Food and Drug Administration (FDA) in response to the FDA’s Advance Notice of Proposed Rulemaking (ANPRM) to develop a nicotine product standard in cigarettes that will lower nicotine to minimally or non-addictive levels. The open comment period on the FDA’s ANPRM ends July 16, 2018. To date, major medical associations, government agencies, tobacco insiders, and the public at large have submitted nearly 3,000 public comments to the FDA. Although some companies in the tobacco industry have requested a 90-day extension of the comment period and have facilitated hundreds of “form letter” comments, the responses from scientists and regulators have been overwhelmingly in favor of the FDA’s plan to dramatically reduce the nicotine content of cigarettes. As the only company in the world growing multiple varieties of Very Low Nicotine flue-cured and burley tobacco varieties, 22nd Century makes possible the FDA’s vital new plan.

Below is a summary of some of the most important comments that the FDA has received to date in response to the ANPRM:

“Given the immense public health benefits predicted by the FDA, the ACC strongly supports the implementation of a nicotine product standard in cigarettes to a minimally addictive or non-addictive level.”“The FDA should move quickly to develop and issue a final regulation to maximize the number of lives saved.”

American College of Cardiology, June 5, 2018

“American Society of Addiction Medicine urges the FDA to move forward with a proposed rule within six months after release of its ANPRM and final rule six months after. In addition, we urge the FDA to establish the tobacco product standard no later than one year after publication, as provided in Section 907 of the Family Smoking Prevention and Tobacco Control Act.”

American Society of Addiction Medicine, June 14 2018

“I am encouraged by the strong actions that the FDA is pursuing to improve the health of our nation, facilitate quitting among smokers who are currently struggling with their addiction, and prevent a future generation from becoming addicted to a highly toxic tobacco product.”

Dorothy K. Hatsukami, PhD, Professor of Psychiatry, University of Minnesota, June 11, 2018

“Immediate nicotine reduction is likely to have the largest public health benefit.”

American Psychological Association, College on Problems of Drug Dependence, Society for Research on Nicotine and Tobacco June 12, 2018

“Our results support a conclusion that a national regulatory policy reducing the nicotine content of cigarettes would reduce the addiction potential of cigarette smoking and that those effects would extend to populations that are highly vulnerable to tobacco addiction.”

Stephen T. Higgins Ph.D., Director, Vermont Center on Behavior and Health, April 26, 2018

“Consistent with the aims of this ANPRM, the 2014 Surgeon General’s Report identified reduction of the nicotine content of tobacco products to make them less addictive as a tobacco “end game” strategy to accomplish the U.S. overall goal of a society free of tobacco-related death and disease.”“This action would contribute to a significant reduction in the lives lost and medical costs associated with the burden of smoking-related morbidity and mortality.”

California Department of Public Health, May 4, 2018

“This proposed rule is a necessary step towards protecting youth and adults from the dangers of nicotine dependence.”

Washington County, Oregon Department of Health and Human Services, June 14th, 2018

“…the Montana Department of Public Health and Human Services strongly supports the FDA’s pursuit to lower the nicotine level of cigarettes to minimally or non-addictive levels…”

Montana Department of Public Health and Human Services, June 14, 2018

“Although we will likely see many more comments to the FDA’s plan to require the reduction of the nicotine content of cigarettes to minimally or non-addictive levels, already there is strong scientific, regulatory, and public support for the plan,” explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “What’s more, very soon, 22nd Century will submit our Company’s extensive comments regarding a drastically reduced nicotine content standard… and we will address, specifically, questions of commercial feasibility.”

https://bit.ly/2za2Op7

Tesaro debt buydown makes it a buy opp: Citi

Tesaro buying down debt below cost of capital. Citi analyst, Robyn Karnauskas, reiterated her Buy rating.

https://bit.ly/2Np1L7O

How Google, Facebook monopolize ideas

In early May Google banned bail-bond companies from advertising on its platforms. Such companies profit from “communities of color and low income neighborhoods when they are at their most vulnerable,” itexplained in a blog post. They use “opaque financing offers that can keep people in debt for months or years.”

That Google can ban ads from an industry that offends its values is not, by itself, noteworthy. Media companies have long decided what content or ads to carry for the same reason. The difference is that even after decades of consolidation, no media company enjoys a U.S. market share as dominant as Google’s in Internet search (close to 90%) or Facebook Inc.’s in social networking. Like earlier bans on payday-loan ads, Google’s bail-bond ad ban, which Facebook copied the next day, effectively kicked an entire industry out of a major advertising channel.

The debate over whether Google, a unit of Alphabet Inc., and Facebook are too big usually revolves around economics: Do they suppress competition for goods and services? The bail-bond ad ban raises a different, and potentially more troubling, possibility: that they also undermine competition for values and ideas. While Google and Facebook claim to be neutral platforms connecting users, advertisers and content providers, decisions about which ads to ban and which content to delete or reclassify are inherently value-laden, even when those values are embedded in an algorithm.

Data monopolies “can actually be more dangerous than traditional monopolies,” Maurice Stucke, a law professor at the University of Tennessee, Knoxville specializing in antitrust, wrote earlier this yearin Harvard Business Review. “They can affect not only our wallets but our privacy, autonomy, democracy, and well-being.”

Bail bonds aren’t a sympathetic industry. For a steep fee, agents agree to pay the court’s required bail if the client doesn’t show up for a court date. They are, however, legal and, in most states, regulated. And the industry says it serves low-income and minority clients because they are caught up in the criminal-justice system without the means to post bail on their own.

Jeff Clayton, executive director of the American Bail Coalition, whose members insure bail agents, says Google gave the industry no opportunity to comment on or appeal the ban. A Google spokeswoman declined to comment. Facebook did consult with both the industry and criminal-justice-reform groups after announcing its ban, a spokesman said.

Bail-bond agents used to advertise in the yellow pages, but as the public abandoned phone books for Google, so did the industry. “There are just no other options,” Mr. Clayton said. The ban doesn’t extend to regular search results, but it makes it harder for individual companies to stand out.

Conservatives tend to see tech companies’ progressive leanings at work in what gets banned or reclassified—for example, Facebook’s labeling of videos by two prominent supporters of President Donald Trump as “unsafe.” Bail bonds and payday loans have long been targets of progressive activist groups.

But as the companies come under growing pressure to police their platforms and weed out “fake news,” a growing range of content gets banned, labeled or deleted for often opaque or arbitrary reasons. ProPublica and Reveal, both nonprofit news publications, have had content dealing with hate groups and immigrant children, respectively, deleted or rejected by Instagram or Facebook. Video artists complain of viewership and ads being restricted because their content violated YouTube’s community standards.

Unhappy users, advertisers and content providers wouldn’t have as much to complain about if Google (which bought YouTube in 2006) and Facebook (which acquired Instagram in 2012) had strong competitors to which they could switch.

Absent such competition, expect pressure for the government to regulate it. But that’s a slippery slope. Politically appointed overseers may simply replace the companies’ judgments with their own. For that reason the Federal Communications Commission long ago gave up policing the nation’s airwaves for fairness.

Better that monopolies not arise in the first place. In a 2001 article Mr. Stucke and Allen Grunes, then attorneys in the Department of Justice’s antitrust division, noted antitrust law has long sought to preserve competition in ideas, not just products. In 1945 the Supreme Court upheld a landmark antitrust suit against the Associated Press for excluding some newspapers and limiting what member newspapers could share. The First Amendment “rests on the assumption that the widest possible dissemination of information from diverse and antagonistic sources is essential to the welfare of the public,” Justice Hugo Black wrote. “Truth and understanding are not wares like peanuts or potatoes,” Justice Felix Frankfurter added.

This isn’t necessarily a reason to break up tech giants: The legal hurdles are almost insurmountable and the consequences highly unpredictable. It is a reason to ask, when these companies announce their next acquisition, if the market for ideas, not just for peanuts and potatoes, will be stronger as a result.

https://bit.ly/2ITCn6z

Study reveals cannabis is not a miracle pain reliever

It’s safe to say most people think cannabis chills you out.

Now researchers have discovered that perception may be stronger than the drug itself.

In a large study of the effect cannabis has on pain in sufferers across Australia, the team from the National Drug and Alcohol Research Center (NDARC) uncovered some unexpected results.

While they found most people “perceived it to help,” in reality, it didn’t really change their level of pain.

Researchers think this might be simply because medicinal cannabis can help people sleep so their pain is more tolerable the next day.

The University of New South Wales study followed 1,500 people over four years to see how pain interfered with their everyday life and whether using medicinal cannabis would change their prescribed opioid use.

Worldwide interest in the area has been growing, particularly for chronic non-cancer pain.

There has also been increasing speculation that using cannabis for pain may allow people to reduce their prescription opioid use.

The results, published in Lancet Public Health on Tuesday, suggest that there is a need for caution given there were “no strong findings supporting a clear role for cannabis for these reasons.”

Participants who were using cannabis had greater pain and anxiety, were not coping as well with their pain, and reported that pain was interfering more in their life.

They found there was no clear evidence that cannabis reduced pain severity or pain interference or led participants to reduce their opioid use or dose.

NDARC director Professor Michael Farrell said medicinal cannabis had been a very hard sell and people needed to approach it with caution.

“People who otherwise wouldn’t have gone near cannabis have been experimenting with it,” he said.

“One of the things we think happens when people report benefits is the sleep and sedation effects it has.”

“Often when you get a good night’s sleep, your pain is a lot more tolerable.”

In what was one of the world’s longest in-depth community studies on pharmaceutical opioids and chronic non-cancer pain, participants were recruited through community pharmacies and completed comprehensive assessments of their pain, physical and mental health, medication and cannabis use annually.

They had been in pain for a median of 10 years and taken prescribed opioids for their pain for a median of four years, with “very high rates of physical and mental health problems.”

Lead author Dr. Gabrielle Campbell said chronic non-cancer pain was a complex problem.

“For most people, there is unlikely to be a single effective treatment,” she said.

“In our study of people living with chronic non-cancer pain who were prescribed pharmaceutical opioids, despite reporting perceived benefits from cannabis use, we found no strong evidence that cannabis use reduced participants’ pain or opioid use over time.”

https://nyp.st/2IS1mYa

Ampio publishes on anti-inflammatory mechanisms of med

Ampio Pharmaceuticals, Inc. (NYSE: AMPE) today announced a basic science manuscript entitled “The Anti-Inflammatory Effect of LMWF5A and N-Acetyl Kynurenine on Macrophages: Involvement of Aryl Hydrocarbon Receptor in Mechanism of Action” has been accepted for publication in Biochemistry and Biophysics Reports.

Dr. David Bar-Or, Ampio’s CSO explained, “This biochemical research uncovered an important part of the mechanism of action of Ampion™ or the low molecular weight fraction of 5% human serum albumin (LMWF5A). We had previously demonstrated that Ampion promotes the activation of anti-inflammatory macrophages while decreasing the activation of pro-inflammatory macrophages.

Here, we show that Ampion significantly decreases the release of pro-inflammatory biomarkers from LPS-stimulated macrophages and that one of the known components of Ampion (N-acetyl kynurenine or NAK) also decreased these biomarkers – albeit to a smaller extent. When an inhibitor of the aryl hydrocarbon receptor (AhR) was included, the anti-inflammatory effect of Ampion was partially blocked while the effect of NAK was completely prevented.

This is a significant finding since activation of the AhR suppresses inflammation by limiting the secretion of pro-inflammatory cytokines and promoting the overexpression of immuno-modulatory mediators. In the literature, it is well known that kynurenine is an agonist of AhR, but our study is the first to describe NAK as a potential AhR agonist. These findings suggest that Ampion and (through) one of its active components (NAK) promote the suppression of activated macrophages, partially via the AhR receptor. Therefore, Ampion, which contains NAK and other anti-inflammatory active moieties, is potentially a useful therapeutic in medical conditions where inflammation is prevalent such as trauma, osteoarthritis, sepsis, and wound healing.”

A link to the full manuscript will be made available when it is published online.

Regulatory Exclusivity and IP protection:The Company believes that Ampion™, a low molecular weight fraction of human serum albumin with anti-inflammatory properties, will be identified as a “reference product” upon FDA approval of their BLA. Reference products are granted twelve years of exclusivity under the PHS Act, 42 U.S.C. § 262(k)(7). Specifically, FDA is not permitted to approve an application for a biosimilar or interchangeable product until 12 years after the date of the first licensure of the reference product. The existing Ampion™ portfolio has patent coverage in all major jurisdictions throughout the world (U.S., Europe, Australia, Brazil, Canada, China, Eurasia, Hong Kong, India, Indonesia, Israel, Japan, Korea, Mexico, Malaysia, New Zealand, Philippines, Singapore, South Africa) for pharmaceutical compositions and methods of treating a range of conditions. The portfolio includes 125 issued patents and 85 pending applications throughout seven primary patent families having expiration dates that extend to 2035.

https://bit.ly/2MP2UVg

Tesla Stops Critical Brake and Roll Test to Meet Production Goals

Tesla likes to cut corners. Following news it eliminated 300 welds, comes news it stopped a brake and roll test.

There are several Tesla stories today, none of them any good.

Brake and Roll

Elon Musk ordered Tesla engineers to stop doing a critical brake and roll test on Model 3s cars.

Tesla CEO Elon Musk ordered his employees to stop putting nearly finished Model 3s through a critical test before leaving the company’s factory in Fremont, California, according to an internal document viewed by Business Insider.

Ron Harbour, a consultant at Oliver Wyman who founded and writes “The Harbour Report,” a worldwide guide to manufacturing, told Business Insider that after everything is installed in a car during the manufacturing process, a manufacturer would have to be very lucky for everything on a car to be in alignment.

“If you just abandon [the test], you could potentially have a lot of quality issues with your customers,” he said. “Every plant does that … It’s part of finishing the build of the car.”

Harbour told Business Insider he was unaware of any test that could adequately replace the brake-and-roll test on a manufacturing line.

Reservations and Deliveries Decline

Goldman Sachs is unimpressed by Tesla meeting its Model 3 goal.

• Goldman Sachs is not impressed with Tesla’s production announcement and reiterates its sell rating for the company’s shares, noting net Model 3 reservations declined to 420,000 from 455,000 last year.
• Tesla said Monday it reached its one-week production goal of 5,000 Model 3 cars for the last week of the June quarter. But the company fell short on its second-quarter deliveries by posting 40,740 vehicles delivered versus the Wall Street consensus expectation of approximately 51,000.

Shouting Elon Musk Changes Rules on the Fly

CNBC comments on a shouting Elon Musk and changing rules.

A tense and short-tempered Chief Executive Elon Musk barked at engineers on the Fremont, California assembly line. Tesla pulled workers from other departments to keep pumping out the Model 3 electric sedans, disrupting production of the Model S and X lines. And weekend shifts were mandatory.

Leading up to Sunday morning’s production milestone, Musk paced the Model 3 line, snapping at his engineers when the around-the-clock production slowed or stopped due to problems with robots, one worker said. Tesla built a new line in just two weeks in a huge tent outside the main factory, an unprecedented move in an industry that takes years to plan out its assembly lines, and said the tented production area accounted for 20 percent of the Model 3s produced last week.

“They were borrowing people from our line all day to cover their (Model 3) breaks so the line would continue to move,” said a Model S worker on Sunday.

Because of the focus on the Model 3, the S line is about 800 cars behind, the worker said.

“They’ve been throwing Model 3s ahead of the S to get painted to try to assure that they make their goal of 5,000,” the worker said. “The paint department can’t handle the volume.”

“He (Musk) is gonna go through an awful lot of people because people are gonna start getting hurt left and right,” by the fast-moving assembly line, a worker said.

Crap Quality

For discussion of the 300 dropped welds, please see Model 3 Assembly Line: Detailed Images of Tesla’s “On the Fly” Manufacturing.

The quality of these rushed vehicles is guaranteed to be crap, just to make a self-imposed production number.

https://bit.ly/2u5KzeB

The Institutions Americans Trust Most And Least

In this era of “fake news”, trust is always being called into question, whether it’s the content in the president’s Twitter feed or the creepy notion that your Amazon Echo is listening in on your private conversations with sinister intentions. Even though “In God We Trust” is the official motto of the United States, distrust is rampant in 21st century America.

But, as Statista’a Niell McCarthy notes, when it comes to the nation’s institutions which are bedrocks of the country, however, trust levels are remaining consistent.

Gallup recently polled U.S. adults about their confidence levels in 15 different societal institutions, finding only three had a majority-level of trust.

You will find more infographics at Statista

Average confidence across the institutions has still remained consistent over the past three decades and all of them garner at least some trust. In 2018, the military remains the most trusted institution with 74 percent of Americans having some or quite a lot of confidence in it.

It comes as little surprise that small business is widely trusted given its importance to the community and it comes second with 67 percent. Even though the police has attracted criticism due to heavy-handed arrests and a spate of controversial shootings, it is the only other institution with majority trust at 54 percent.

When it comes to the church and organized religion, trust levels stand at 38 percent while the presidency is close behind with 37 percent.

Television news and Congress come last with just 20 and 11 percent trust among the public respectively.

https://bit.ly/2KuQp4h