Company Asks FDA for Emergency OK of Its COVID Pill

Pharmaceutical giant Merck and its partner Ridgeback Biotherapeutics announced Monday that it has asked the Food and Drug Administration for emergency approval of its COVID-19 pill after the experimental drug showed “compelling results” in clinical trials.

The pill, called molnupiravir, cut the risk of hospitalization or death in patients with mild to moderate COVID-19 by about 50 percent in a late-stage trial, according to data from a phase three clinical trial shared earlier this month.

“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” Merck’s CEO Robert Davis said in a statement.

After seeing early success with the pill in clinical trials, the company — in consultation with an independent data committee and staff from the FDA — decided to end the trial early and seek an emergency use authorization.

If the FDA grants Merck an EUA for the pill, it would be the first oral antiviral for COVID-19. (Read more from “Company Asks FDA for Emergency OK of Its COVID Pill” HERE)

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Southwest Cancels Hundreds More Flights — Is Vax Mandate To Blame?

Southwest Airlines canceled hundreds more flights Monday after the airline was forced to ground nearly 2,000 flights over the weekend, blaming the issues on weather and staffing amid speculation that the debacle is tied to the company’s recent COVID-19 vaccine mandate.

The world’s largest low-cost carrier canceled almost 350 flights — or one in ten scheduled departures — as of Monday at 7 a.m. ET, according to data from Flight Aware. That marks the highest cancellation rate of any major US airline by far, according to the site.

More than 300 other Southwest flights were facing delays, the site’s data showed.

The airline’s latest woes come after it had to ground more than 25 percent of its scheduled flights on Sunday. . .

The mass cancelations and delays on the busy Columbus Day weekend come after the airline announced last week that it would require all of its employees to get the COVID-19 vaccine, as called for by President Biden earlier this year. Employees must get vaccinated before Dec. 8 or face termination. The Dallas, Texas-based airline has approximately 56,000 employees. (Read more from “Southwest Cancels Hundreds More Flights — Is Vax Mandate To Blame?” HERE)

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Pentagon Tech Chief Quits in Frustration, Says U.S. Has No “Fighting Chance” Against China; Ex-Pentagon Official: U.S. Has Lost the Technology Battle to China

By Futurism. In a blistering new interview with the Financial Times, the Pentagon’s former chief software officer said that he resigned in protest of slow technological innovation in the United States — and, in a provocative twist, opined that China is dominating in the space, particularly at developing advanced artificial intelligence.

“We have no competing fighting chance against China in 15 to 20 years,” Nicolas Chaillan, who quit the Defense Department in September, told the newspaper in his first interview since leaving the post. “Right now, it’s already a done deal; it is already over in my opinion.”

Chaillan’s complaints are numerous. He blasted cybersecurity in some parts of the US government as “kindergarten level,” decried lack of cooperation between the US military and its tech sector, and said that he had wasted his time “fixing basic cloud things and laptops.”

Most of all, though, he seems furious that China is pulling ahead in the realms of artificial intelligence, machine learning and cyberattack capability. In a particularly grim critique, he complained that US tech giants like Google have been hesitant to dive into particularly controversial AI research, whereas Beijing isn’t held back by those pesky ethical debates. (Read more from “Pentagon Tech Chief Quits in Frustration, Says U.S. Has No “Fighting Chance” Against China” HERE)

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Ex-Pentagon Official: U.S. Has Lost the Technology Battle to China

By Washington Examiner. The former inaugural chief software officer at the Pentagon said he believes the United States has already lost the technological battle against China.

Nicolas Chaillan, 37, who worked for three years on a Department of Defense-wide effort to enhance cybersecurity and became the first chief software officer of the Air Force , resigned last month in part due to his belief that the U.S. is getting outmaneuvered by foreign powers.

“We have no competing fighting chance against China in 15 to 20 years. Right now, it’s already a done deal; it is already over in my opinion,” he told the Financial Times in an article published on Sunday, adding there was “good reason to be angry.”

Chaillan argued that the emerging technological advances and developments pose a much more important aspect to defense than commonly thought of military hardware, such as fighter jets.

Some of the U.S. cyberdefense systems are at a “kindergarten level,” he said, later noting that China is angling to dominate the military sphere in the future. Even though the U.S. still spends more than three times on defense as the Chinese do, Chaillan said much of that funding is being spent on the wrong things and that bureaucracy and regulations play a role in it, too. (Read more from “Ex-Pentagon Official: U.S. Has Lost the Technology Battle to China” HERE)

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GOP Governor Issues Order Banning COVID Vaccine Mandate

Texas Gov. Greg Abbott issued an executive order on Monday prohibiting any entity, including private businesses, from imposing Covid-19 vaccination requirements on employees or customers.

“The COVID-19 vaccine is safe, effective, and our best defense against the virus, but should remain voluntary and never forced,” said Abbott said in a statement.

Abbott, a Republican, said in his order that it was prompted by the Biden administration’s vaccine federal mandate, which the governor called federal overreach.

President Joe Biden announced a mandate last month requiring companies with 100 or more employees to ensure that their workforces are vaccinated or regularly tested. The Labor Department has yet to release details of the emergency rule, but Biden last week called on companies to act now and not to wait for the requirement to go into effect. (Read more from “GOP Governor Issues Order Banning COVID Vaccine Mandate” HERE)

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State Bans Small Gas Engines, Including Mowers, Chainsaws

California took another step toward its goal of ridding the state of all gas-powered engines thanks to a new bill signed by Gov. Gavin Newsom on Saturday.

The new law will ban the sale of all off-road, gas-powered engines, including generators, lawn equipment, pressure washers, chainsaws, weed trimmers, and even golf carts. Under the new law , these machines must be zero-emissions, meaning they will have to be either battery-powered or plug-in, according to the Los Angeles Times.

“This is a pretty modest approach to trying to limit the massive amounts of pollution that this equipment emits, not to mention the health impact on the workers who are using it constantly,” Marc Berman, the bill’s author, told the outlet. “It’s amazing how people react when they learn how much this equipment pollutes, and how much smog forming and climate changing emissions that small off-road engine equipment creates.”

The new law is expected to affect nearly 50,000 small businesses . California’s budget includes $30 million to help professional landscapers and gardeners quit using gas-powered equipment, but even then, the budget is still not capable of bearing the full financial burden. (Read more from “State Bans Small Gas Engines, Including Mowers, Chainsaws” HERE)

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The ‘Whipgate’ Hoax Investigation Has Already Crumbled

It’s been nearly a month since a Democratic operative created a fake narrative about the behavior of Border Patrol agents defending the U.S.-Mexico border from illegal immigrants, but the initially swift condemnation from the highest levels of the Biden administration has turned into a slow-walked investigation.

Despite promising that the investigation would take “days,” Mayorkas and DHS have now taken more than two weeks and still haven’t concluded their hastily ordered probe. . .

At the time back, [Department of Homeland Security Secretary Alejandro] Mayorkas pledged that the investigation would happen swiftly to provide information about exactly what had happened. The problem with the Biden administration’s quick condemnation of reports — many of which had to be corrected due to utter inaccuracy — is that the alleged actions they condemned didn’t actually happen. . .

When The Hill queried DHS about their missed deadline, officials said they still have no clear end-date for the report. “The investigation is ongoing,” DHS claimed. “The Department is committed to a thorough, independent, and objective process,” adding they “are also committed to transparency and will release the results of the investigation once it is complete.” (Read more from “The ‘Whipgate’ Hoax Investigation Has Already Crumbled” HERE)

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At Least 15 Shot, 1 Dead, in ‘Hellish’ Bar Shooting

A mass shooting at a crowded Minnesota bar early Sunday left at least 15 people shot — including a young woman who died — and “bullet holes all over,” according to local police.

Officers found a “hellish situation” when they arrived at the Seventh Street Truck Park bar in St. Paul about 12:15 a.m., cops said in a statement.

“In an instant, they found themselves caught in a hellish situation,” St. Paul Police Chief Todd Axtell said.

Gunshot victims were found inside the bar, on the sidewalk and in the street, according to the Pioneer Press. The woman, who hasn’t been publicly identified, was pronounced dead at the scene. Police said she was in her 20s. . .

Three men, ages 33, 32 and 29, were arrested, CBS Minnesota reported. (Read more from “At Least 15 Shot, 1 Dead, in ‘Hellish’ Bar Shooting” HERE)

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Hospital Uses Photo of Vaccine-Fired Nurse to Recruit for Her Replacement

Besides and in addition to any question of legality of the actions, there’s no doubt many Americans feel corporations are abusing their workers if they fire them for failing to comply with COVID-19 mandates.

But one health-care company, Asante, based in southern Oregon, is being trashed online for firing one such worker, and then using her own image in an advertisement seeking a replacement for her.

The report on Facebook comes from Tiana Therrien, who reveals, “I am losing my job due to the vaccine mandate.”

She then reproduces Asante’s ad seeking from the public referrals for “top-notch healthcare professionals.”

The image shows a young woman in a canoe on a lake, with the logo, “Help build our team and get a bonus!” and it’s signed “Asante.” (Read more from “Hospital Uses Photo of Vaccine-Fired Nurse to Recruit for Her Replacement” HERE)

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Nurse Takes Legal Action Against Hospital Waging War on Christianity

A longtime nurse in the United Kingdom is taking legal action against a London National Health Service Trust after officials there insisted that her small cross necklace, worn in honor of her Christian faith, was a health menace.

That appeared to be a false claim, since the managers repeatedly offered her a compromise that she could wear the necklace if it was not visible, ignoring any potential health aspects of the dispute.

Officials at Christian Concern say the Christian Legal Center now is representing Mary Onuoha in her dispute with Croydon University Hospital in south London.

Her lawyers are pointing out in their case that others in the hospital were allowed to wear “jewelry, hijabs, saris, turbans and religious bracelets” without a problem under the dress code which states: “The Trust welcomes the variety of appearances brought by individual styles, choices and religious requirements regarding dress; this will be treated sensitively and will be agreed on an individual basis with the Manager and Trust and must conform to health, safety and security regulations, infection prevention and control and moving and handling guidelines. The wearing of saris, turbans, kirpan, skullcaps, hijabs, kippahs and clerical collars arising from particular cultural / religious norms are seen as part of welcoming diversity.” . . .

“NHS management exposed that the real reason for their demands was not safety and hygiene, but the visibility of the cross. In a letter to Mrs Onuoha on 9 August 2018, her line manager and Clinical Lead Practitioner, wrote: ‘I offered you a compromise of using a longer chain so your necklace was out of sight but you refused,'” the Christian Concern report explained. (Read more from “Nurse Takes Legal Action Against Hospital Waging War on Christianity” HERE)

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New Virus Poses ‘An Existential Threat to Life as We Know It on This Planet’

The Biden administration’s apparent unwillingness to conduct a serious official investigation of the origin of SARS-CoV-2 that holds China accountable for its actions and lack of cooperation could result in a pandemic much more lethal that the current one, warns a leading researcher.

Dr. Steven Quay, whose research became part of a State Department probe of the origin of COVID-19 under President Trump, told Fox News’ Martha MacCallum on Friday that “all of the evidence points toward the lab theory.” . . .

But it’s more vital than ever to stop the dangerous “gain-of-function” research going on at the Wuhan Institute of Virology, he said.

Raw data from patient specimens posted in the National Institutes of Health’s gene bank showed researchers at the Wuhan lab in December 2019 were manipulating genes from the highly lethal Nipah virus, Quay said.

The Nipah virus, which causes severe inflammation of the brain or encephalitis, has a death rate of about 80%, Quay warned. (Read more from “New Virus Poses ‘An Existential Threat to Life as We Know It on This Planet'” HERE)

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