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Daily Archives: October 28, 2021
SIFMA and the SIFMA Foundation to honor Kathleen Murphy, James Reynolds, Jr. and Paul E. Purcell at the 2021 SIFMA Foundation Tribute Dinner – WSAW
Posted: October 28, 2021 at 8:57 am
SIFMA Foundation's annual event will take place on October 27th at Cipriani 25 Broadway in lower Manhattan
Published: Oct. 26, 2021 at 8:00 AM CDT
NEW YORK, Oct.26,2021 /PRNewswire/ --SIFMA and the SIFMA Foundationwill host their annual Tribute Dinner at Cipriani 25 Broadway in lower Manhattan on October 27 from 6 pm 9 pm. TheFoundation'sannualdinner isanevening to celebrate and raise awareness for theimportanceof youth financial education and literacy and the 20 million youth served to date by the SIFMA Foundation.
The dinner will also serve tohonor Kathleen Murphy, President, Personal Investing, Fidelity Investments, for her leadership and commitment to the financial industry and financial education, and James Reynolds Jr., Founder, Chairman, & CEO, Loop Capital, for his longstanding commitment and dedication to helping millions of young people become financially capable. The Foundation will also pay a posthumous tribute to Paul E. Purcell, Former Chairman, President & CEO, Baird, for his lifetime of leadership in the area of education and youth financial literacy.
"This is an excellent opportunity to honor three luminaries,"said Melanie Mortimer, President of the SIFMA Foundation. "Kathy, Jim and Paul havesupported the Foundation's mission in providing financial education for young people of all backgrounds through innovative programsthat promotefinancial independence and real-world learning. Moreover, they serve as role models and as sterling representatives for young people of all backgrounds aspiring to careers in the financial services industry."
Mortimer noted that now, more than ever, "it is critical to develop financial literacy for American youth," because only one-third of adult Americans can pass a simple financial literacy test and only 24% of millennials have basic financial knowledge, according to a study conducted by FINRA, the Financial Industry Regulatory Authority. Particularly alarming is that rate of financial literacy among Blacks and Hispanics falls below that number.
"That just doesn't add up if we are truly committed to economic mobility and a secure future, especially for individuals living in marginalized communities," Mortimer said. "One major purpose of the SIFMA Foundation is making sure youth of all backgrounds have access to effective ways to learn about how financial markets work."
Kathleen Murphy concurs about the essentiality of this purpose. She said, "I am exceptionally delightedto behonored at this year's SIFMA Foundation Tribute Dinner. The SIFMA Foundationhas always done an incredible job in providingfinancial education programs and tools that strengthen economic opportunity acrossallcommunities."
"As a Chair and Officer on the SIFMA Board, I know directly about the impact the Foundation continues to have infostering knowledge and understanding of the financial markets for individuals of all backgrounds, and especially Black and Brown youth,"saidReynolds.
Baird's former Chairman, President & CEO, Paul E. Purcell, was committed to advancing educational access.
"We'd like to thank the SIFMA Foundation for recognizing Paul's contribution to our industry and his overarching commitment to education," said Steve Booth, Baird Chairman, President & CEO. "Paul had a special calling - and that was helping under-served students. He firmly believed we have an obligation to ensure everyone regardless of where they live or their circumstances, has access to a quality education."
Murphy is a nationally recognized thought leader and speaker on such vital topics as women investing and empowerment, financial literacy, client experience, digital transformation, talent, and leadership.
Reynolds runs the largest minority-owned financial services firm and one of the largest privately-held investment banks in the United States. He has been a leader advocating for diversity, inclusion, equity and belonging in the workplace.
About the SIFMA Foundation for Investor Education
The SIFMA Foundation is dedicated to fostering knowledge and understanding of the financial markets for individuals of all backgrounds, with a focus on youth. Drawing on the involvement and expertise of educators and the financial industry, the SIFMA Foundation provides financial education programs and tools that strengthen economic opportunities across communities and increase individuals' access to the benefits of the global marketplace. Notable Foundation programs include The Stock Market Game, which has enabled more than 20 million students to become financially prepared for life, the InvestWrite national essay competition, the Capitol Hill Challenge, and Invest It Forward. For more information on the work of the SIFMA Foundation, visit Facebook,YouTube,@SIFMAFoundation,LinkedIn,Instagram.
About SIFMA
SIFMA is the leading trade association for broker-dealers, investment banks and asset managers operating in the U.S. and global capital markets. On behalf of our industry's nearly 1 million employees, we advocate on legislation, regulation and business policy, affecting retail and institutional investors, equity and fixed income markets and related products and services. We serve as an industry coordinating body to promote fair and orderly markets, informed regulatory compliance, and efficient market operations and resiliency. We also provide a forum for industry policy and professional development. SIFMA, with offices in New York and Washington, D.C., is the U.S. regional member of the Global Financial Markets Association (GFMA). For more information, visit http://www.sifma.org.
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The above press release was provided courtesy of PRNewswire. The views, opinions and statements in the press release are not endorsed by Gray Media Group nor do they necessarily state or reflect those of Gray Media Group, Inc.
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Gal Yifrachs incredible journey to the top – The Jerusalem Post
Posted: at 8:57 am
The whole secret of a successful life is to find out what is ones destiny to do, and then do it. - Henry Ford
You probably have seen successful people and wonder what are their secrets to success. These successful people seem to have done everything right and always made the right calls at the ideal times. Whats certain is they do not possess any extraordinary abilities or superpowers. Some of them say they took an ordinary path to success but had well-laid out plans that led them to their destiny.
Gal Yifrach, a high-stakes professional poker player and an entrepreneur is among the successful people that are mentors to many. He is a renowned player in the poker community with numerous accolades to his name, including the highly coveted, non-monetary award, World Series of Poker bracelet. Gal is also celebrated in high-stakes professional poker as one of the top talented players with vast experience in the game.
Prior to the success and fame, Gal shares one of the most inspiring stories: from being homeless to rubbing shoulders with some of the worlds most prominent personalities. He had moved to a different country without any money or family to turn to for help. Without a job, Gal found it hard to survive. At one time he was completely broke and was forced to spend nights in a car. Life was becoming hard to bear, and he knew he had to do something to change his situation.
With hard work, determination and resilience, Gal was able to keep his dreams alive. He knew his destiny was in the poker world, and thats where he invested most of his time and efforts. He had the belief that anything was possible and, true to his words, things started getting better for him. He is now a successful high-stakes professional poker player living his dream.
Gal also works hard to inspire other poker players to continue putting in the work striving for success. He does not believe in giving up but rather staying resilient no matter how tough the journey gets.
I believe that all is possible if you want it hard enough. Anything is possible if you want it, even if you cant see it now; there are difficult times in life for everyone, but never give up on your dreams, says Gal.
Gal now wants to expand his passive income streams and build on his financial independence. He wants to live his best life while inspiring others to be the best versions of themselves.
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Gal Yifrachs incredible journey to the top - The Jerusalem Post
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Independence Contract Drilling, Inc. Announces Timing of Third Quarter 2021 Financial Results and Conference Call – Tyler Morning Telegraph
Posted: at 8:57 am
HOUSTON, Oct. 22, 2021 /PRNewswire/ --Independence Contract Drilling, Inc. (the "Company") (NYSE: ICD) today announced that it will release its third quarter 2021 results before the New York Stock Exchange opens on Tuesday, November 2, 2021. This release will be followed by a conference call for investors at 11:00 a.m. Central Time (12:00 p.m. Eastern Time) to discuss the Company's third quarter 2021 results.
The call can be accessed live over the telephone by dialing (855) 239-3115 or for international callers, (412) 542-4125. A replay will be available shortly after the call and can be accessed by dialing (877) 344-7529 or for international callers, (412) 317-0088. The passcode for the replay is 10161416. The replay will be available until November 9, 2021.
Interested parties may also listen to a simultaneous webcast of the conference call by logging onto the Company's website at http://www.icdrilling.com in the Investor Relations section. A replay of the webcast will also be available for approximately 30 days following the call.
About Independence Contract Drilling, Inc.
Independence Contract Drilling provides land-based contract drilling services for oil and natural gas producers in the United States. The Company owns and operates a fleet of pad optimal rigs that are specifically engineered and designed to accelerate its clients' production profiles and cash flows from their most technically demanding and economically impactful oil and gas properties. For more information, visit http://www.icdrilling.com.
Investor Contacts:
Investor Relations:
Investor.relations@icdrilling.com
(281) 598-1211
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Leonard Green Gives $2 Billion to Workers of Portfolio Firms – Yahoo Finance
Posted: at 8:57 am
(Bloomberg) -- Leonard Green & Partners has shared more than $2 billion of profits with employees of companies it backs, a move that won praise this week on the sidelines of the Milken Institute Global Conference.
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In 2021 alone, over 7,500 portfolio-company employees participated in profit-sharing or other distributions in addition to their regular compensation, said John Danhakl, a managing partner at the Los Angeles-based private equity firm. We believe in the stakeholder model where the employees who contribute to our companies performances share in the successes and the value they help create.
Employees of companies including Mister Car Wash Inc., SRS Distribution and Charter Next Generation are among those that received a piece of the profits, and more than $1 billion was shared with workers outside of the executive suite. Leonard Green took Mister Car Wash public in June and remains its biggest shareholder.
The firm, with more than $50 billion of assets under management, said it has been a early participant in the conscious capitalism movement and seeks to partner with companies and management teams that believe in shared success, which can include providing equity stakes and sale bonuses.
Some industry executives who attended the Milken conference in Beverly Hills congratulated Jonathan Sokoloff, also a Leonard Green managing partner, as word of its largesse spread.
It is the most gratifying thing weve ever done at Leonard Green over our 30-plus year history, Sokoloff said. We have a multitude of stories of employees at our companies who have achieved life-changing financial independence that many thought would never be possible, and our goal is to increase the impact we can have.
Story continues
Other alternative asset managers also share profits with employees of portfolio companies. Earlier this year, New York-based KKR & Co. disbursed $500 million of profits from the sale of manufacturer Ingersoll Rand Inc. to 16,000 workers at the Davidson, North Carolina-based industrial-equipment manufacturer.
Read more: KKR Hands $500 Million to Ingersoll Rand Workers After 162% Gain
Beginning in 2011, KKR implemented an employee ownership model within its industrials portfolio. This enables profit-sharing with staff, including hourly workers, in at least 11 portfolio companies including Charter Next Generation, which it co-owns with Leonard Green, a KKR spokeswoman said.
(Updates with KKR profit-sharing in last paragraph.)
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Leonard Green Gives $2 Billion to Workers of Portfolio Firms - Yahoo Finance
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Atlas Shrugged: Full Book Summary | SparkNotes
Posted: at 8:55 am
In an environment of worsening economicconditions, Dagny Taggart, vice president in charge of operations,works to repair Taggart Transcontinentals crumbling Rio Norte Lineto service Colorado, the last booming industrial area in the country.Her efforts are hampered by the fact that many of the countrysmost talented entrepreneurs are retiring and disappearing. The railroadscrisis worsens when the Mexican government nationalizes TaggartsSan Sebastian Line. The line had been built to service FranciscodAnconias copper mills, but the mills turn out to be worthless.Francisco had been a successful industrialist, and Dagnys lover,but has become a worthless playboy. To solve the railroads financialproblems, Dagnys brother Jim uses political influence to pass legislationthat destroys Taggarts only competition in Colorado. Dagny mustfix the Rio Norte Line immediately and plans to use Rearden Metal,a new alloy created by Hank Rearden. When confronted about the SanSebastian mines, Francisco tells Dagny he is deliberately destroyingdAnconia Copper. Later he appears at Reardens anniversary partyand, meeting him for the first time, urges Rearden to reject thefreeloaders who live off of him.
The State Science Institute issues a denunciation of Rearden metal,and Taggarts stock crashes. Dagny decides to start her own companyto rebuild the line, and it is a huge success. Dagny and Reardenbecome lovers. Together they discover a motor in an abandoned factorythat runs on static electricity, and they seek the inventor. Thegovernment passes new legislation that cripples industry in Colorado.Ellis Wyatt, an oil industrialist, suddenly disappears after settingfire to his wells. Dagny is forced to cut trains, and the situationworsens. Soon, more industrialists disappear. Dagny believes thereis a destroyer at work, taking men away when they are most needed.Francisco visits Rearden and asks him why he remains in businessunder such repressive conditions. When a fire breaks out and theywork together to put it out, Francisco understands Reardens lovefor his mills.
Rearden goes on trial for breaking one of the new laws,but refuses to participate in the proceedings, telling the judgesthey can coerce him by force but he wont help them to convict him.Unwilling to be seen as thugs, they let him go. Economic dictatorWesley Mouch needs Reardens cooperation for a new set of socialistlaws, and Jim needs economic favors that will keep his ailing railroadrunning after the collapse of Colorado. Jim appeals to Reardenswife Lillian, who wants to destroy her husband. She tells him Rearden andDagny are having an affair, and he uses this information in a trade.The new set of laws, Directive 10-289,is irrational and repressive. It includes a ruling that requiresall patents to be signed over to the government. Rearden is blackmailedinto signing over his metal to protect Dagnys reputation.
Dagny quits over the new directive and retreats to a mountain lodge.When she learns of a massive accident at the Taggart Tunnel, shereturns to her job. She receives a letter from the scientist shehad hired to help rebuild the motor, and fears he will be the nexttarget of the destroyer. In an attempt to stop him from disappearing,she follows him in an airplane and crashes in the mountains. Whenshe wakes up, she finds herself in a remote valley where all theretired industrialists are living. They are on strike, calling ita strike of the mind. There, she meets John Galt, who turns outto be both the destroyer and the man who built the motor. She fallsin love with him, but she cannot give up her railroad, and she leavesthe valley. When she returns to work, she finds that the governmenthas nationalized the railroad industry. Government leaders wanther to make a speech reassuring the public about the new laws. Sherefuses until Lillian comes to blackmail her. On the air, she proudlyannounces her affair with Rearden and reveals that he has been blackmailed. Shewarns the country about its repressive government.
With the economy on the verge of collapse, Francisco destroys therest of his holdings and disappears. The politicians no longer evenpretend to work for the public good. Their vast network of influencepeddling creates worse chaos, as crops rot waiting for freight trainsthat are diverted for personal favors. In an attempt to gain controlof Franciscos mills, the government stages a riot at Rearden Steel.But the steelworkers organize and fight back, led by Francisco,who has been working undercover at the mills. Francisco saves Reardenslife, then convinces him to join the strike.
Just as the head of state prepares to give a speech onthe economic situation, John Galt takes over the airwaves and deliversa lengthy address to the country, laying out the terms of the strikehe has organized. In desperation, the government seeks Galt to makehim their economic dictator. Dagny inadvertently leads them to him,and they take him prisoner. But Galt refuses to help them, evenafter he is tortured. Finally, Dagny and the strikers rescue himin an armed confrontation with guards. They return to the valley,where Dagny finally joins the strike. Soon, the countrys collapseis complete and the strikers prepare to return.
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Opinion | What ‘Dune’ Gets Right that ‘Foundation’ Doesn’t – The New York Times
Posted: at 8:55 am
The blogger John Rogers once noted that there are two novels that can shape the lives of bookish 14-year-olds: Atlas Shrugged and The Lord of the Rings. One of these novels, he asserted, is a childish fantasy that can leave you emotionally stunted; the other involves orcs.
Well, I was a bookish 14-year-old, but my touchstones were two different novels: Isaac Asimovs Foundation and Frank Herberts Dune.
Many social scientists, it turns out, are science fiction readers. For example, quite a few experts on international relations who I know are fanatics about the TV version of The Expanse. I think its because good science fiction involves building imaginary worlds that are different from the world we know, but in interesting ways that relate to the attempt to understand why society is the way it is.
Anyway, thats my excuse for devoting todays newsletter not to the latest scary developments in politics and economics but to a much happier event: the U.S. release of a wonderful, satisfying film version of Dune the first movie Ive seen in a theater since the pandemic began.
Before I get there, however, a word about the new Foundation TV series, which is being released one episode a week on Apple TV+.
The Foundation trilogy had a huge impact on my teenage self. For those whove never read it, its about social scientists who use their knowledge to save galactic civilization. I wanted to be Hari Seldon, the brilliant mathematician who leads the effort; this economics thing was as close as I could get.
Foundation might seem unfilmable. It mostly involves people talking, and its narrative inverts the hero-saves-the-universe theme that burns many acres of CGI every year. The story spans centuries; in each episode everything appears to be on the brink, and it seems as if only desperate efforts by the protagonists can save the day. But after each crisis, Seldons prerecorded hologram appears to explain to everyone what just happened and why the successful resolution was inevitable given the laws of history.
So how does the Apple TV+ series turn this into a visually compelling tale? It doesnt. What it does instead is remake Star Wars under another name. There are indispensable heroes, mystical powers, even a Death Star. These arent necessarily bad things to include in a TV series, but theyre completely antithetical to the spirit of Asimovs writing. Pretending that this series has anything to do with the Foundation novels is fraudulent marketing, and Ive stopped watching.
Now on to Dune. The book is everything Foundation isnt: Theres a glittering, hierarchical society wracked by intrigue and warfare, a young hero of noble birth who may be a prophesied messiah, a sinister but alluring sisterhood of witches, fierce desert warriors and, of course, giant worms.
And yes, its fun. When I was a teenager, my friends and I would engage in mock combat in which the killing blow had to be delivered slowly to penetrate your opponents shield which will make sense if you read the book or watch the movie.
What makes Dune more than an ordinary space opera are two things: its subtlety and the richness of its world-building.
Thus, the Bene Gesserit derive their power not from magic but from deep self-control, awareness and understanding of human psychology. The journey of Paul Atreides is heroic but morally ambiguous; he knows that if he succeeds, war and vast slaughter will follow.
And the world Herbert created is given depth by layers of cultural references. He borrowed from Islamic and Ayurvedic traditions, from European feudalism and more Dune represents cultural appropriation on a, well, interstellar scale. Its also deeply steeped in fairly serious ecological thinking.
So why was the 1984 film a disaster? Because the director yes, David Lynch either didnt grasp the subtlety and richness or decided that audiences couldnt handle it. That is, he did to Dune what Apple TV+ has done to Foundation. For example, in the book theres the weirding way of battle, which is about using psychology and deception to overcome foes; in Lynchs film this was replaced with some kind of gadget.
The great thing about Denis Villeneuves Dune: Part I is that he respects the audience enough to retain the books spirit. He trimmed the narrative to reduce it to filmable size and even so, his two and a half hours cover only the first half of the book but he didnt dumb it down. Instead, he relies on spectacle and spine-tingling action to hold our attention despite the density of the story. In so doing he made a film worthy of the source material.
I wouldnt say that this Dune matches the vision I had when reading the book. Its better. The visuals surpass my imagination those ornithopters! The actors give the characters more depth than the books author previously had in my mind.
Will this labor of love sell to a mass audience (and allow Villeneuve to finish his story)? The early box office looks good, and this does seem like the kind of film people will see twice I did so sales may hold up longer than usual. But I guess well find out.
In any case, all of us former bookish 14-year-olds finally have the Dune movie we always wanted to see. Sometimes, things actually do go right.
Some guy wrote the introduction to a special edition of Foundation.
Was Dune climate fiction?
Another novel that definitely is climate fiction.
Maybe politicians would act if we called whats happening to the West Duneification?
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Opinion | What 'Dune' Gets Right that 'Foundation' Doesn't - The New York Times
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Romney Says Billionaires Will Just Buy Paintings if Taxes Raised – Second Nexus
Posted: at 8:55 am
Republican Senator Mitt Romney of Utah has proven to be one of the few Republican elected officials willing to denounce former President Donald Trump and the far-right faction of the party currently inhabiting Congress. Romney twice voted to convict Trump in his impeachment trials and has since become persona non grata among the party's base.
That doesn't mean Romney has dispensed with age-old Republican principles, such as protecting the nation's richest from any increase in taxes, even at the expense of expanded protections for the middle class.
In a recent Fox News interview, Romney rejected the idea of increasing taxes for billionaires, who pay taxes at lower rates than most Americans, if they pay them at all.
Watch below.
Senator Romney expresses concern that taxing billionaires could cause them to invest in paintings or ranches rather https://t.co/ENFb23nG25
Romney specifically spoke out against proposed capital gains tax expansions, which would tax the super wealthy on investments as the investments accrue value, instead of just when these investments are sold.
Romney told Fox's Bret Baier:
Romney's analysis that the super rich will abandon the stock market over a capital gains tax increase seems far-fetched. The top 10% of wealthy Americans already own nearly 90% of stocks. The top 1% hold more than half of corporate equities and mutual-fund shares.
However, comments defending America's wealthiest aren't new coming from Romney. As the Republican presidential nominee in 2012, Romney dealt his campaign a death blow in the final weeks after video surfaced of him railing against the "47 percent" of Americans who didn't pay income taxes.
Romney said of these people, most of whom are explicitly excluded from the tax code due to poverty:
It's long been established that Romney, who himself is worth around a quarter billion, would rather increase taxes for working class Americans than on the wealthiest.
He took some heat for his Fox News comments online.
Billionaires' wealth surged during the pandemic as everyone else suffered an enormous recession, and as soon as you https://t.co/LloYFZgMFQ
Bill Gates owns 300,000 acres of farmland. https://t.co/MZTd6BKKYQ
Its truly incredible how little self-reflection Mitt has done since tanking his presidential campaign with this ex https://t.co/nHa0Qy5NIq
Shed a tear for the downtrodden billionaire. Can we get Sally Struthers to do some fundraising commercials for them https://t.co/ZE4Dih5qTt
Love when rich dudes like Romney start gesturing at Atlas Shrugged and peddling this nonsense whenever taxing the w https://t.co/Ep9QrCS0HG
If they invested in things that build jobs, they probably wouldnt be billionaires now, would they? https://t.co/fv0BBCXl5M
Others found Romney's comments downright insulting in how outdated they were.
Hey Mitt. 1988 called and even they think this is a tired acid-washed-jeans argument suited for that bygone era of https://t.co/tnRQaxEHDX
The talking points are stale 30 years later. https://t.co/rASWyQd8rD
When a lord tells the peasants trickle down still has a shot. Just hang in there. https://t.co/mS9m2iOEDx
Increasing taxes on the wealthy are a key component in financing President Joe Biden's ambitious infrastructure agenda, which could create millions of jobs if passed in its full formrebutting Romney's claim that the United States can't create jobs by taxing billionaires.
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Romney Says Billionaires Will Just Buy Paintings if Taxes Raised - Second Nexus
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Alternative medicine, over a trend in Zacatecas – Sunday Vision
Posted: at 8:54 am
The World Health Organization (The World Health Organization) defines alternative or complementary medicine as a health care practice It is not part of the traditions or traditional medicine of a particular country, and it is not fully integrated into the mainstream health system. In some countries, like ours, they are used interchangeably with traditional medicine.
Based on the definition of the World Health Organization, Federal Health Secretariat He identifies the four areas of greatest presence:
Although there are many studies on alternative medicine in the world, its effect on the health of the population is still unknown. Many clinicians incorporate knowledge about these practices into their training, with the goal of instructing patients about the effects of some.
In Zacatecas, one of the most responsive areas in this area was UAZ Alternative Medicine Clinic, where one of the most requested services was physical therapy, followed by acupuncture and ozone therapy.
Following the same line, only in the area that includes the Metropolitan Municipality and its neighbor Guadalupe, there are a series of clinics, centers and health food stores dedicated to alternative medicine. The areas in which they work are the following:
It is important to remember that some of these practices do not have medical support, so the responsibility lies with those who go to them.
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Alternative medicine, over a trend in Zacatecas - Sunday Vision
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Alternative medicines regulations: Should AYUSH focus on safe-to-consume or efficacy? – The Times of India Blog
Posted: at 8:54 am
In the post-corona world, if there is a sector with a massive boom ahead, it is of alternative medicines. And as India is home to one of the oldest and highly advanced curative traditions in form of Ayurveda, it is a great opportunity that India can capitalize on, provided we have right policies in place at the earliest that will allow Ayurveda to fill the vacuum that allopathy is leaving behind.
If we dont act soon, greedy market forces will take Ayurveda on the same path that allopathy has gone, i.e., abject commercialization sans social values.The biggest stumbling block ahead for Ayurvedic medicines is to get legal recognition in a world where allopathic drug laws rule the roost.
As allopathic medicines pass through a process of clinical trails to get empirical confirmation for safe consumption and efficacy, the simple regulatory solution is to push Ayurvedic medicines on the same route for approval. The biggest advantage of taking such a regulatory route is that it will allow Ayurvedic medicines to access global market and if we play our IPR game properly, Indian manufacturers can enjoy the massive valuation that western drug companies have been thriving on.
The problem with allopathy-like validation for Ayurvedic medicines is that the curative logic and processes of Ayurveda are not exactly like allopathy where very direct cause-and-effect relationships are immediately visible in all medications. A lot of Ayurvedic medicines target chronic diseases and offer long-term benefits that a conventional clinical trial-based process will not be able to register or confirm. This means that establishing efficacy under the current for-allopathy framework will not be easy for all Ayurvedic medicines.
As allopathy and Ayurveda stem from different model of human body, it is also unfair to demand that a fish has to pass the test of climbing a tree.
So, what could be the way forward if we want Ayurveda to claim a place in the healthcare market?
At this point, AYUSH, the main regulatory authority has opted to solve the problem by going diametrically in opposite direction by accepting that traditional herbs and herbal formulation being in use since ages, they are exempted from seeking statutory approval used for allopathy drugs.
Such a policy may show short term gain, but what it can (and is, if one switches on ones TV set in the afternoon) lead to is rampant and lawless market where false claims will be made by the crooked in the name of AYUSH to make a quick buck.The solution that I see is to separate the safe-to-consume and efficacy and design a policy that forces manufacturers to have transparency about their claims.
AYUSH needs to ensure that any alternative medicine from any stream or tradition is made to pass through tests that prove that its is safe-to-consume.
There can be absolutely no compromise with ensuring safety for consumption, even if it is a traditional practice going back to a thousand years.
One the other hand, the need to establish efficacy should not be mandatory for AYUSH medicines, but with a condition, and that is a clear admission made on the package that the efficacy is based on the traditional knowledge and not established through clinical trials.
If a manufacturer wishes to opt for clinical trials and pass through the process it is clear that that medicine needs no classification as it is as much an allopathic medicine as any.
If AYUSH opts for such a clarity and India communicates this to the world regulators, there is a great possibility that we will find buyers across the world who will trust the backing of Ayurvedic traditional knowledge without having clinical proof as long as there is a clear proof that it is not a harmful-to-consume medication.
As long as a substance is safe to consume, getting into efficacy issue is actually a regulatory overreach as it is not correct for any regulator to go into the faith-based choice of a consumer. In fact, if we start putting allopathic drugs through the same logic, a lot of them may fail when the timeframe of clinical trials is prolonged as we now know that there are many a long-term side effects that escape the scrutiny of clinical trials.
Curing ones body is a fundamental right of a human being and the state must not control ones freedom of choice regarding the option one takes beyond a point.
Views expressed above are the author's own.
END OF ARTICLE
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Insmed Reports Third Quarter 2021 Financial Results and Provides Business Update – KPVI News 6
Posted: at 8:54 am
BRIDGEWATER, N.J., Oct. 28, 2021 /PRNewswire/ --Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today reported financial results for the third quarter ended September 30, 2021 and provided a business update.
"In the third quarter of 2021, Insmed made important progress against our strategic priorities, including steady performance of our commercial operations, advancement of our clinical development programs in line with expectations, and meaningful acceleration of our translational medicine efforts with a sharp focus on disruptive technologies that we believe will have a significant impact on patients' lives," commentedWill Lewis, Chair and Chief Executive Officer of Insmed. "Notably, we are excited about our launch progress for ARIKAYCE in Japan, where we are already seeing positive early trends. As we navigate this critical execution period for Insmed, we are well-capitalized and highly driven to launch the next phase of growth for our company and to serve many more patients around the world."
Recent Corporate Developments & Program Highlights
ARIKAYCE
Brensocatib
TPIP
Third Quarter 2021 Financial Results
Balance Sheet and Planned Investments
As of September 30, 2021,Insmedhad cash and cash equivalents of$846.6 million. The Company's total operating expenses for the third quarter of 2021 were $150.4 million. Adjusted R&D expenses for the third quarter of 2021 were $64.3 million and adjusted SG&A expenses for the third quarter of 2021 were $51.8 million. Adjusted R&D expenses and adjusted SG&A expenses are non-GAAP measures, which we describe further below.
The Company plans to continue to invest in the following key activities:
(i)
U.S. commercialization of ARIKAYCE;
(ii)
launch activities for ARIKAYCE in initial European countries and in Japan; and
(iii)
clinical trial activities, including (a) advancement of the frontline clinical trial program for ARIKAYCE (ARISE and ENCORE), (b) advancement of the Phase 3 ASPEN study of brensocatib in patients with bronchiectasis, (c) advancement of clinical development of TPIP, and (d) advancement of our translational medicine efforts.
Conference Call
Insmedwill host a conference call beginning today at8:30 AM Eastern Time. Shareholders and other interested parties may participate in the conference call by dialing (844) 200-6205 (U.S. toll free), (646) 904-5544 (U.S. local), or +44-208-0682-558 (international) and referencing access code 594997. The call will also be webcast live on the Company's website atwww.insmed.com.
A replay of the conference call will be accessible approximately 1 hour after its completion through November 26, 2021 by dialing (866) 813-9403 (U.S. toll free), (929) 458-6194 (U.S. local), or +44-204-525-0658 (international) and referencing access code 963633. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company's website at http://www.insmed.com.
Non-GAAP Financial Measures
In addition tothe U.S.generally accepted accounting principles (GAAP) results, this earnings release includes non-GAAP financial measures: adjusted R&D expenses, whichInsmeddefines as R&D expenses less stock-based compensation expense and depreciation; and adjusted SG&A expenses, which Insmed defines as SG&A expenses less stock-based compensation and depreciation. A reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measure is presented in the table attached to this press release.
Management believes that these non-GAAP financial measures are useful to both management and investors in analyzing our ongoing business and operating performance. Management believes that providing this non-GAAP information to investors, in addition to the GAAP results, allows investors to view our financial results in the way that management views financial results.Management does not intend the presentation of these non-GAAP financial measures to be considered in isolation or as a substitute for results prepared in accordance with GAAP. In addition, these non-GAAP financial measures may differ from similarly named measures used by other companies.
About ARIKAYCE
ARIKAYCE is approved inthe United Statesas ARIKAYCE(amikacin liposome inhalation suspension), in Europe as ARIKAYCELiposomal 590 mg Nebuliser Dispersion, and in Japan as ARIKAYCE inhalation 590 mg (amikacin sulfate inhalation drug product).Current international treatment guidelines recommend the use of ARIKAYCE for appropriate patients. ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin, an established antibiotic that was historically administered intravenously and associated with severe toxicity to hearing, balance, and kidney function. Insmed's proprietary PULMOVANCE liposomal technology enables the delivery of amikacin directly to the lungs, where liposomal amikacin is taken up by lung macrophages where the infection resides, while limiting systemic exposure. ARIKAYCE is administered once daily using the LamiraNebulizer System manufactured by PARI Pharma GmbH (PARI).
About PARI Pharma and the LamiraNebulizer System
ARIKAYCE is delivered by a novel inhalation device, the LamiraNebulizer System, developed by PARI. Lamirais a quiet, portable nebulizer that enables efficient aerosolization of ARIKAYCE via a vibrating, perforated membrane. Based on PARI's 100-year history working with aerosols, PARI is dedicated to advancing inhalation therapies by developing innovative delivery platforms to improve patient care.
About Brensocatib
Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the treatment of patients with bronchiectasis and other neutrophil-mediated diseases. DPP1 is an enzyme responsible for activating neutrophil serine proteases (NSPs), such as neutrophil elastase, in neutrophils when they are formed in the bone marrow. Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction and inflammatory mediation. In chronic inflammatory lung diseases, neutrophils accumulate in the airways and result in excessive active NSPs that cause lung destruction and inflammation. Brensocatib may decrease the damaging effects of inflammatory diseases such as bronchiectasis by inhibiting DPP1 and its activation of NSPs. Brensocatib is an investigational drug product that has not been approved for any indication in any jurisdiction.
About TPIP
Treprostinil palmitil inhalation powder (TPIP) is a dry powder formulation of treprostinil palmitil, a treprostinil prodrug consisting of treprostinil linked by an ester bond to a 16-carbon chain. Developed entirely in Insmed's laboratories, TPIP is a potentially highly differentiated prostanoid being evaluated for the treatment of patients with PAH and other rare and serious pulmonary disorders. TPIP is administered in a capsule-based inhalation device. TPIP is an investigational drug product that has not been approved for any indication in any jurisdiction.
IMPORTANT SAFETY INFORMATION FOR ARIKAYCE IN THE U.S.
WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS
ARIKAYCE has been associated with an increased risk of respiratory adverse reactions, including hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases.
Hypersensitivity Pneumonitis has been reported with the use of ARIKAYCE in the clinical trials. Hypersensitivity pneumonitis (reported as allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction to ARIKAYCE) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (3.1%) compared to patients treated with a background regimen alone (0%). Most patients with hypersensitivity pneumonitis discontinued treatment with ARIKAYCE and received treatment with corticosteroids. If hypersensitivity pneumonitis occurs, discontinue ARIKAYCE and manage patients as medically appropriate.
Hemoptysis has been reported with the use of ARIKAYCE in the clinical trials. Hemoptysis was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (17.9%) compared to patients treated with a background regimen alone (12.5%). Ifhemoptysis occurs, manage patients as medically appropriate.
Bronchospasmhas been reported with the use of ARIKAYCE in the clinical trials. Bronchospasm (reported as asthma, bronchial hyperreactivity, bronchospasm, dyspnea, dyspnea exertional, prolonged expiration, throat tightness, wheezing) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (28.7%)compared to patients treated with a background regimen alone (10.7%). If bronchospasm occurs during the use of ARIKAYCE, treat patients as medically appropriate.
Exacerbations of underlying pulmonary diseasehas been reported with the use of ARIKAYCE in the clinical trials. Exacerbations of underlying pulmonary disease (reported as chronic obstructive pulmonary disease (COPD), infective exacerbation of COPD, infective exacerbation of bronchiectasis) have been reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (14.8%) compared to patients treated with background regimen alone (9.8%). If exacerbations of underlying pulmonary disease occur during the use of ARIKAYCE, treat patients as medically appropriate.
Anaphylaxis and Hypersensitivity Reactions:Serious and potentially life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients taking ARIKAYCE. Signs and symptoms include acute onset of skin and mucosal tissue hypersensitivity reactions (hives, itching, flushing, swollen lips/tongue/uvula), respiratory difficulty (shortness of breath, wheezing, stridor, cough), gastrointestinal symptoms (nausea, vomiting, diarrhea, crampy abdominal pain), and cardiovascular signs and symptoms of anaphylaxis (tachycardia, low blood pressure, syncope, incontinence, dizziness). Before therapy with ARIKAYCE is instituted, evaluate for previous hypersensitivity reactions to aminoglycosides. If anaphylaxis or a hypersensitivity reaction occurs, discontinue ARIKAYCE and institute appropriate supportive measures.
Ototoxicity has been reported with the use of ARIKAYCE in the clinical trials. Ototoxicity (including deafness, dizziness, presyncope, tinnitus, and vertigo) were reported with a higher frequency in patients treated with ARIKAYCE plus background regimen (17%) compared to patients treated with background regimenalone (9.8%). This was primarily driven by tinnitus (7.6% in ARIKAYCE plus background regimen vs 0.9% in the background regimen alone arm) and dizziness (6.3% in ARIKAYCE plus background regimen vs 2.7% in the background regimen alone arm).Closely monitor patients with known or suspected auditory or vestibular dysfunction during treatment with ARIKAYCE. If ototoxicity occurs, manage patients as medically appropriate, including potentially discontinuing ARIKAYCE.
Nephrotoxicitywas observed during the clinical trials of ARIKAYCE in patients with MAC lung disease but not at a higher frequency than background regimen alone. Nephrotoxicity has been associated with the aminoglycosides. Close monitoring of patients with known or suspected renal dysfunction may be needed when prescribing ARIKAYCE.
Neuromuscular Blockade: Patients with neuromuscular disorders were not enrolled in ARIKAYCE clinical trials. Patients with known or suspected neuromuscular disorders, such as myasthenia gravis, should be closely monitored since aminoglycosides may aggravate muscle weakness by blocking the release of acetylcholine at neuromuscular junctions.
Embryo-Fetal Toxicity:Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides, including ARIKAYCE, may be associated with total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use ARIKAYCE during pregnancy, or become pregnant while taking ARIKAYCE should be apprised of the potential hazard to the fetus.
Contraindications: ARIKAYCE is contraindicated in patients with known hypersensitivity to any aminoglycoside.
Most Common Adverse Reactions: The most common adverse reactions in Trial 1 at an incidence 5% for patients using ARIKAYCE plus background regimen compared to patients treated with background regimen alone were dysphonia (47% vs 1%), cough (39% vs 17%), bronchospasm (29% vs 11%), hemoptysis (18% vs 13%), ototoxicity (17% vs 10%), upper airway irritation (17% vs 2%), musculoskeletal pain (17% vs 8%), fatigue and asthenia (16% vs 10%), exacerbation of underlying pulmonary disease (15% vs 10%), diarrhea (13% vs 5%), nausea (12% vs 4%), pneumonia (10% vs 8%), headache (10% vs 5%), pyrexia (7% vs 5%), vomiting (7% vs 4%), rash (6% vs 2%), decreased weight (6% vs 1%), change in sputum (5% vs 1%), and chest discomfort (5% vs 3%).
Drug Interactions:Avoid concomitant use of ARIKAYCE with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity. Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Avoid concomitant use of ARIKAYCE with ethacrynic acid, furosemide, urea, or intravenous mannitol.
Overdosage: Adverse reactions specifically associated with overdose of ARIKAYCE have not been identified.Acute toxicity should be treated with immediate withdrawal of ARIKAYCE, and baseline tests of renal function should be undertaken. Hemodialysis may be helpful in removing amikacin from the body. In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment.
U.S. INDICATION
LIMITED POPULATION: ARIKAYCEis indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium aviumcomplex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients.
This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by Month 6. Clinical benefit has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Limitation of Use: ARIKAYCE has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease.
Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visitwww.fda.gov/medwatch, or call 1800FDA1088. You can also call the Company at 1-844-4-INSMED.
Please seeFull Prescribing Information.
About Insmed
Insmed Incorporated is a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases. Insmed's first commercial product is a first-in-disease therapy approved in the United States, Europe, and Japan to treat a chronic, debilitating lung disease. The Company is also progressing a robust pipeline of investigational therapies targeting areas of serious unmet need, including neutrophil-mediated inflammatory diseases and rare pulmonary disorders. Insmed is headquartered in Bridgewater, New Jersey, with a growing footprint across Europe and in Japan. For more information, visit http://www.insmed.com.
Forward-looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements.
The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timing discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: failure to obtain, or delays in obtaining, regulatory approvals for ARIKAYCE outside the U.S., Europe or Japan, or for the Company's product candidates in the U.S.,Europe,Japanor other markets; failure to successfully commercialize ARIKAYCE, the Company's only approved product, in the U.S., Europe or Japan (amikacin liposome inhalation suspension, Liposomal 590 mg Nebuliser Dispersion, and amikacin sulfate inhalation drug product, respectively), or to maintain U.S., European or Japanese approval for ARIKAYCE; business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises; impact of the COVID-19 pandemic and efforts to reduce its spread on the Company's business, employees, including key personnel, patients, partners and suppliers; risk that brensocatib does not prove effective or safe for patients in ongoing and future clinical studies, including the ASPEN study; risk that TPIP does not prove to be effective or safe for patients in ongoing and future clinical studies; uncertainties in the degree of market acceptance of ARIKAYCE by physicians, patients, third-party payors and others in the healthcare community; the Company's inability to obtain full approval of ARIKAYCE from the U.S. Food and Drug Administration, including the risk that the Company will not successfully or in a timely manner complete the study to validate a PRO tool and the confirmatory post-marketing clinical trial required for full approval of ARIKAYCE; inability of the Company, PARI or the Company's other third-party manufacturers to comply with regulatory requirements related to ARIKAYCE or the LamiraNebulizer System; the Company's inability to obtain adequate reimbursement from government or third-party payors for ARIKAYCE or acceptable prices for ARIKAYCE; development of unexpected safety or efficacy concerns related to ARIKAYCE or the Company's product candidates; inaccuracies in the Company's estimates of the size of the potential markets for ARIKAYCE or its product candidates or in data the Company has used to identify physicians, expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; the Company's inability to create an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of ARIKAYCE or any of the Company's product candidates that are approved in the future; failure to obtain regulatory approval to expand ARIKAYCE's indication to a broader patient population; failure to successfully conduct future clinical trials for ARIKAYCE, brensocatib, TPIP and the Company's other product candidates due to the Company's limited experience in conducting preclinical development activities and clinical trials necessary for regulatory approval and its potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; risks that our clinical studies will be delayed or that serious side effects will be identified during drug development; failure of third parties on which the Company is dependent to manufacture sufficient quantities of ARIKAYCE or the Company's product candidates for commercial or clinical needs, to conduct the Company's clinical trials, or to comply with the Company's agreements or laws and regulations that impact the Company's business or agreements with the Company; the Company's inability to attract and retain key personnel or to effectively manage the Company's growth; the Company's inability to successfully integrate its recent acquisitions and appropriately manage the amount of management's time and attention devoted to integration activities; risks that the Company's acquired technologies, products and product candidates are not commercially successful; the Company's inability to adapt to its highly competitive and changing environment; the Company's inability to adequately protect its intellectual property rights or prevent disclosure of its trade secrets and other proprietary information and costs associated with litigation or other proceedings related to such matters; restrictions or other obligations imposed on the Company by agreements related to ARIKAYCE or the Company's product candidates, including its license agreements with PARI and AstraZeneca AB, and failure of the Company to comply with its obligations under such agreements; the cost and potential reputational damage resulting from litigation to which the Company is or may become a party, including product liability claims; the Company's limited experience operating internationally; changes in laws and regulations applicable to the Company's business, including any pricing reform, and failure to comply with such laws and regulations; inability to repay the Company's existing indebtedness and uncertainties with respect to the Company's ability to access future capital; and delays in the execution of plans to build out an additional third-party manufacturing facility approved by the appropriate regulatory authorities and unexpected expenses associated with those plans.
The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, "Risk Factors," in the Company's Annual Report on Form 10-K for the year endedDecember 31, 2020 and any subsequent Company filings with the Securities and Exchange Commission (SEC).
The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Financial Statements and Reconciliation Follow
INSMED INCORPORATED
Consolidated Statements of Net Loss
(in thousands, except per share data)
(unaudited)
Three Months Ended September 30,
Nine Months Ended September 30,
2021
2020
2021
2020
Product revenues, net
$ 46,757
$ 43,643
$ 132,337
$ 122,998
Operating expenses:
Cost of product revenues (excluding amortization
of intangible assets)
10,183
10,622
30,864
29,010
Research and development
70,347
41,411
196,392
113,343
Selling, general and administrative
60,280
46,585
169,007
147,594
Amortization of intangible assets
1,264
1,248
3,790
3,745
Change in fair value of deferred and contingent
consideration liabilities
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Insmed Reports Third Quarter 2021 Financial Results and Provides Business Update - KPVI News 6
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