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Media Blackout: Nasal Spray that is 99% Effective Against COVID-19 in its Phase 3 Clinical Trial – Now Approved in India, Israel, Bahrain, Indonesia & Thailand


Reported By Jim Hoft | Published February 25, 2022

Read more at https://www.thegatewaypundit.com/2022/02/media-blackout-nasal-spray-99-effective-covid-19-phase-3-clinical-trial-now-approved-india-israel-bahrain-indonesia-thailand/

The Canadian pharmaceutical company SaNOtize Research & Development Corp., (SaNOtize), and Glenmark Pharmaceuticals Limited (Glenmark), announced earlier this month the successful outcomes of a nasal spray in its Phase 3 clinical trials and now approved by India’s drug regulator as a treatment for adult patients with COVID-19 who have a risk of progression of the disease. TrialSite is the first to report on this.

“The study confirmed that SaNOtize’s Nitric Oxide Nasal Spray (NONS) represents a safe and effective antiviral treatment that shortens the course of COVID-19, and could prevent the transmission of COVID-19,” according to their news release.

The SaNOtize Nitric Oxide Nasal Spray (NONS) is designed to kill the Covid-19 virus in the upper airways, preventing it from incubating and spreading to the lungs. It contained anti-microbial properties with a direct virucidal effect on Covid-19.

Read their news release published at Business Wire and below:

In a randomized, double-blind, placebo-controlled, parallel-arm study at 20 clinical sites across India that evaluated 306 patients, NONS reduced the SARS-CoV-2 log viral load in COVID-19 patients by more than 94% within 24 hours of treatment, and by more than 99% in 48 hours as compared to saline control.

Treatment also demonstrated, in the high-risk group (n=218), a statistically significant greater proportion of patients who achieved a combination of clinical and virological cure, based on the World Health Organization (WHO) Progression Scale. Moreover, the median time to negative PCR, in this group, was 4 days in the treatment group compared with 8 days in the control. Test subjects included patients infected with different variants, likely including Delta and Omicron. There were no significant adverse health events recorded in the Phase 3 trial, or in over 500 subjects treated so far with NONS in clinical trials.

The reduction in log viral load corroborates the reduction of viral load in the UK Phase 2 trials (a reduction of 95% in 24 hours and 99% in 72 hours), conducted in March 2021 by Ashford and St Peter’s Hospitals NHS Foundation Trust, and Berkshire and Surrey Pathology Services, and published in the Journal of Infection in August 2021.

“These results definitively substantiate the safety and efficacy of NONS in the fight against COVID-19,” said Dr. Gilly Regev, SaNOtize Co-Founder and CEO. “We are thrilled to be able to provide COVID patients with an affordable product that has been shown to deliver a faster cure. And with the proven safety profile of NONS, we look forward to this becoming the first line of treatment and potentially defense for COVID infection worldwide.”

The SaNOtize treatment is designed to kill the virus in the upper airways, preventing it from incubating and spreading to the lungs. It is based on nitric oxide (NO), a natural nanomolecule produced by the human body with proven anti-microbial properties shown to have a direct effect on SARS-CoV-2, the virus that causes COVID-19. The pharmacology, toxicity, and safety data for NO use in humans has been well-established for decades. The NO molecule released from NONS is identical to the one delivered in its gaseous form to treat persistent pulmonary hypertension, or Blue Baby Syndrome, in newborn babies.

With the receipt of manufacturing and marketing approval from India’s drug regulator, SaNOtize’s strategic partner, Glenmark, will launch NONS commercially in India under the brand name FabiSpray®. The approval is for the treatment of adult patients with COVID-19 who have a risk of progression of the disease, which includes either persons over the age of 45, non-vaccinated people and/or those with comorbidities. Glenmark entered into an exclusive long-term strategic partnership with SaNOtize in August 2021 to manufacture, market and distribute NONS for COVID-19 treatment in India and other Asian markets including Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste, and Vietnam.

NONS has a marketing authorization as a Class I Medical Device in the EU. NONS is also approved and being sold in Israel, Thailand, Indonesia, and Bahrain, under the name enovid or VirX.

“As viral load is an important determinant of disease severity and transmission of COVID-19 infection, demonstration of reduction in the viral load is expected to have significant clinical consequences from a patient and community perspective,” said Dr. Monika Tandon, Senior Vice President and Head – Clinical Development, Global Specialty/Branded Portfolio for Glenmark. “In the current scenario, with new emerging variants exhibiting high transmissibility, this novel product provides a useful option in the world’s fight against COVID-19.”

Glenmark will submit the clinical trial data for publication in a peer-reviewed journal in order to share its findings.

Randomized, Double-Blind, Placebo-Controlled Phase 3 Trials – Details

  • Patients in the Glenmark Phase 3 clinical trial in India self-administered a dose of 2 sprays per nostril, six times a day for a seven-day treatment period, along with standard supportive care.
  • The primary and secondary outcome measures demonstrated the efficacy and safety of the NONS treatment arm over the control arm, which was administered normal saline nasal spray as placebo in double-blind manner.
  • The trial also included a subgroup analysis for patients with a high risk of disease progression, including either non-vaccinated patients, patients in middle- and older-age groups, and/or patients with co-morbidities.
  • Reduction in log viral load in the NONS group was statistically significant and superior to the control group in the full population and high-risk population (p < 0.05). Similar results were seen in the un-vaccinated group. The primary endpoint was achieved and confirmed in all analyses.
  • Significantly higher proportion of patients became negative on the RT-PCR test in the NONS group as compared to the placebo group. The time to virological cure was four days in the NONS group and eight days in the placebo group (p < 0.05).
  • A significantly higher proportion of patients demonstrated a 2-point clinical status improvement on the WHO Progression Scale, the most clinically validated point system used in clinical trials, in the NONS group as compared to the placebo group in the high-risk group (p < 0.05).
  • Data suggests role of NONS in prevention of COVID-19, which is consistent with a faster viral reduction.
  • NONS was safe and well tolerated by all patients who were part of the clinical trial. There were no reports of moderate or severe or serious adverse events or death in the study. An independent Data and Safety Monitoring Board (DSMB) concluded that NONS was safe in COVID-19 patients.

“NONS destroys the virus, blocks entry into the nasal cavity and halts replication of the virus, which rapidly reduces viral load. This is important because viral load has been linked to infectivity, poor health outcomes and complications from Long COVID,” said Dr. Chris Miller, Chief Science Officer and co-founder of SaNOtize. “Amid evidence of waning efficacy for some vaccines and higher breakthrough rates, there is currently a lack of an antiviral therapy that is effective against COVID-19 and its variants that can be made widely and affordably available to the public. This is what makes NONS a critical weapon in ending the pandemic and preventing future outbreaks.”

Jim Hoft

Jim Hoft is the founder and editor of The Gateway Pundit, one of the top conservative news outlets in America. Jim was awarded the Reed Irvine Accuracy in Media Award in 2013 and is the proud recipient of the Breitbart Award for Excellence in Online Journalism from the Americans for Prosperity Foundation in May 2016.

NAFTA Is 20 Years Old – Here Are 20 Facts That Show How It Is Destroying The Economy


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http://www.infowars.com/nafta-is-20-years-old-here-are-20-facts-that-show-how-it-is-destroying-the-economy/

NAFTA Is 20 Years Old – Here Are 20 Facts That Show How It Is Destroying The Economy

Image Credits: David Dees

by Michael Snyder

Economic Collapse Blog | August 15, 2014

 

Imperial President ObamaBack in the early 1990s, the North American Free Trade Agreement was one of the hottest political issues in the country. When he was running for president in 1992, Bill Clinton promised that NAFTA would result in an increase in the number of high quality jobs for Americans that it would reduce illegal immigration. Ross Perot warned that just the opposite would happen.

He warned that if NAFTA was implemented there would be a giant sucking sound as thousands of businesses and millions of jobs left this country. Most Americans chose to believe Bill Clinton. Well, it is 20 years later and it turns out that Perot was right and Clinton was dead wrong. But now history is repeating itself, and most Americans don’t even realize that it is happening. As you will read about at the end of this article, Barack Obama has been negotiating a secret trade treaty that is being called “NAFTA on steroids”, and if Congress adopts it we could lose millions more good paying jobs.

It amazes me how the American people can fall for the same lies over and over again. The lies that serial liar Barack Obama is telling about “free trade” and the globalization of the economy are the same lies that Bill Clinton was telling back in Cloward Pevin with explanationthe early 1990s. The following is an excerpt from a recent interview with Paul Craig Roberts

I remember in the 90′s when former Presidential candidate Ross Perot emphatically stated that NAFTA (North American Free Trade Agreement) would create a giant “sucking sound” of jobs being extracted away from the U.S. He did not win the election, and NAFTA was instituted on Jan. 1, 1994. Now, 20 years later, we see the result of all the jobs that have been “sucked away” to other countries.

According to an article by the Economic Policy Institute on 1/3/14:

“Clinton and his collaborators promised that the deal would bring “good-paying American jobs,” a rising trade surplus with Mexico, and a dramatic reduction in illegal immigration. Considering that thousands of kids are pouring over the border as we speak, well, how’d that work out for us?

Many Americans like to remember Bill Clinton as a “great president” for some reason. Well, it turns out that he was completely and totally wrong about NAFTA. The following are 20 facts that show how NAFTA is destroying the economy…

#1 More than 845,000 American workers have been officially certified for Trade Adjustment Assistance because they lost their jobs due to imports from Mexico or Canada or because their factories were relocated to those nations.

#2 Overall, it is estimated that NAFTA has cost us well over a million jobs.

#3 U.S. manufacturers pay Mexican workers just a little over a dollar an hour to do jobs that American workers used to do.

#4 The number of illegal immigrants living in the United States has more than doubled since the implementation of NAFTA.

#5 In the year before NAFTA, the U.S. had a trade surplus with Mexico and the trade deficit with Canada was only 29.6 billion dollars. Last year, the U.S. had a combined trade deficit with Mexico and Canada of177 billion dollars.

#6 It has been estimated that the U.S. economy loses approximately 9,000 jobs for every 1 billion dollars of goods that are imported from overseas.

#7 One professor has estimated that cutting the total U.S. trade deficit in half would create 5 million more jobs in the United States.

#8 Since the auto industry bailout, approximately 70 percent of all GM vehicles have been built outside the United States. In fact, many of them are now being built in Mexico.

#9 NAFTA hasn’t worked out very well for Mexico either. Since 1994, the average yearly rate of economic growth in Mexico has been less than one percent.

#10 The exporting of massive amounts of government-subsidized U.S. corn down into Mexico has destroyed more than a million Mexican jobs and has helped fuel the continual rise in the number of illegal immigrants coming north.

#11 Someone making minimum wage in Mexico today can buy 38 percent fewer consumer goods than the day before NAFTA went into effect.

#12 Overall, the United States has lost a total of more than 56,000manufacturing facilities since 2001.

#13 Back in the 1980s, more than 20 percent of the jobs in the United States were manufacturing jobs. Today, only about 9 percent of the jobs in the United States are manufacturing jobs.

#14 We have fewer Americans working in manufacturing today than we did in 1950 even though our population has more than doubled since then.

#15 Back in 1950, more than 80 percent of all men in the United States had jobs. Today, only 65 percent of all men in the United States have jobs.

#16 As I wrote about recently, one out of every six men in their prime working years (25 to 54) do not have a job at this point.

#17 Because we have shipped millions of jobs overseas, the competition for the jobs that remain has become extremely intense and this has put downward pressure on wages. Right now, half the country makes$27,520 a year or less from their jobs.

#18 When adults cannot get decent jobs, it is often children that suffer the most. It is hard to believe, but more than one out of every five children in the United States is living in poverty in 2014.

#19 In 1994, only 27 million Americans were on food stamps. Today, more than 46 million Americans are on food stamps.

#20 According to Professor Alan Blinder of Princeton University, 40 million more U.S. jobs could be sent offshore over the next two decades if current trends continue.

For much more on this, please watch the video by Charlie LeDuff. It is well worth a few minutes of your time…A Service Member

So if NAFTA is so bad for American workers, then why don’t our politicians just repeal it?

Well, unfortunately most of them are not willing to do this because it is part of a larger agenda. For decades, politicians from both major political parties have been working to slowly integrate North America. The eventual goal is to turn North America into another version of the European Union.

Just check out what former general and CIA chief David Petraeus had to say about this

“After America comes North America,” Petraeus said confidently in answering the question about what comes after the United States, the theme of the panel discussion. “Are we on the threshold of the North American decade, question mark? I threw that away — threw away the question mark — and boldly proclaimed the coming North American decade, says the title now.” He also boasted about how the three economies have been put “together” over the last 20 years as part of the “implementation” of the North American Free Trade Act.

The “highly integrated” forces of Canada, the United States, and Mexico, Petraeus continued, will become the world’s powerhouse for energy and science. “There are four revolutions that are ongoing at various levels in each of the countries but foremost in the United States,” said the former CIA chief, who now serves as chairman of the KKR Global Institute. “The energy revolution is the first of those, which has created the biggest change in geopolitics since the rise of China since 1978.” The other “revolutions” include IT, manufacturing, and life sciences, which, “as highly integrated as they are, allow you to argue that after America comes North America,” he added.

Econ-Plans-590-LAWhen you hear our politicians talk about “free trade”, what they are really talking about is integrating us even further into the emerging one world economic system. And over the past couple of years, Barack Obama has been negotiating a secret treaty which would send the deindustrialization of America into overdrive. The formal name of this secret agreement is “the Trans-Pacific Partnership”, and it would ultimately result in millions more good jobs being sent to the other side of the planet where it is legal to pay slave labor wages. The following is a description of this insidious treaty from one of my previous articles

Did you know that the Obama administration is negotiating a super secret “trade agreement” that is so sensitive that he isn’t even allowing members of Congress to see it? The Trans-Pacific Partnership is being called the “NAFTA of the Pacific” and “NAFTA on steroids”, but the truth is that it is so much more than just a trade agreement. This treaty has 29 chapters, but only 5 of them have to do with trade. Most Americans don’t realize this, but this treaty will fundamentally change our laws regarding Internet freedom, health care, the trading of derivatives, copyright issues, food safety, environmental standards, civil liberties and so much more. It will also merge the United States far more deeply into the emerging one world economic system. Initially, twelve nations will be a party to this treaty including the United States, Mexico, Canada, Japan, Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore and Vietnam. Together, those nations represent approximately 40 percent of global GDP. It is hoped that additional nations such as the Philippines, Thailand and Colombia will join the treaty later on.

Unfortunately, most Americans are as uneducated about these issues as they were back in 1994.

That is why we need to get this information out to as many people as we can.

So what is your perspective on all of this? Please feel free to share your thoughts by posting a comment below…

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