U.S. report concluded COVID-19 may have leaked from Wuhan lab – WSJ
June 7, 2021; 10:45 PM EDT
Reuters – A report on the origins of COVID-19 by a U.S. government national laboratory concluded that the hypothesis of a virus leak from a Chinese lab in Wuhan is plausible and deserves further investigation, the Wall Street Journal said on Monday, citing people familiar with the classified document.
The study was prepared in May 2020 by the Lawrence Livermore National Laboratory in California and was referred to by the State Department when it conducted an inquiry into the pandemic’s origins during the final months of the Trump administration, the WSJ report said.
Lawrence Livermore’s assessment drew on a genomic analysis of the COVID-19 virus, the Journal said. Lawrence Livermore declined to comment on the Wall Street Journal report.
President Joe Biden said last month he had ordered aides to find answers to the origin of the virus. read more
U.S. intelligence agencies are considering two likely scenarios – that the virus resulted from a laboratory accident or that it emerged from human contact with an infected animal – but they have not come to a conclusion, Biden said.
A still-classified U.S. intelligence report circulated during former President Donald Trump’s administration alleged that three researchers at China’s Wuhan Institute of Virology became so ill in November 2019 that they sought hospital care, U.S. government sources have said.
U.S. officials have accused China of not being transparent about the virus’ origins, a charge Beijing has denied.
Separately, Mike Ryan, a top World Health Organization official said on Monday the WHO cannot compel China to divulge more data on COVID-19’s origins, while adding it will propose studies needed to take understanding of where the virus emerged to the “next level”. read more
Earlier this month, U.S. infectious disease expert Dr. Anthony Fauci called on China to release the medical records of nine people whose ailments might provide vital clues into whether COVID-19 first emerged as the result of a lab leak.
Our Standards: The Thomson Reuters Trust Principles.
UK’s Johnson Urges Talks As Unions Threaten “Biggest Rail Strike In Modern History”
UK’s Johnson Urges Talks As Unions Threaten "Biggest Rail Strike In Modern History"
Authored by Alexander Zhang via The Epoch Times,
British Prime Minister Boris Johnson has urged rail unions to talk to the government before causing “irreparable damage” with strike action.
The National Union of Rail, Maritime, and Transport Workers (RMT) is holding a ballot of its 40,000 members on plans to strike over jobs, pay, and conditions. The ballot is set to close on Tuesday, and the union has claimed that a yes vote could lead to “the biggest rail strike in modern history.”
Another union, the Transport Salaried Staffs’ Association (TSSA), has also warned of a “summer of discontent” with similar action on the way unless pay disputes are resolved.
The prime minister’s official spokesman said on Monday:
“Railways are going through difficult times with passenger numbers down. We need to make sure they’re fit for the future.”
He said the government wants “a fair deal for staff, for passengers, and taxpayers” so that “money isn’t taken away from other essential services” such as the National Health Service.
“The prime minister is firmly of the view that unions should talk to the government before causing irreparable damage to our railways—strikes should be the last resort not the first,” he added.
Transport Secretary Grant Shapps told The Sunday Telegraph that ministers are looking at drawing up laws which would make industrial action illegal unless a certain number of staff are working.
Shapps said the government hopes the unions will “wake up and smell the coffee” and suggested that strikes could put more people off rail travel.
He also accused unions of going straight to industrial action rather than using it as a last resort, adding that railways were already on “financial life support” because of the CCP (Chinese Communist Party) virus pandemic.
Referring to a pledge in the Conservative Party’s 2019 election manifesto, which promised minimum services during rail strikes, he said:
“We had a pledge in there about minimum service levels. If they really got to that point then minimum service levels would be a way to work towards protecting those freight routes and those sorts of things.”
Unions have reacted to the threat with anger.
RMT General Secretary Mick Lynch said, “Any attempt by Grant Shapps to make effective strike action illegal on the railways will be met with the fiercest resistance from RMT and the wider trade union movement.”
He said the government needs to “focus all their efforts on finding a just settlement” to the rail dispute rather than “attack the democratic rights of working people.”
CytoDyn Inc (OTCMKTS: CYDY) On the Comeback Trail (HIV Leronlimab Update)
CytoDyn Inc (OTCMKTS: CYDY) continues to move steadily higher in recent trading since hitting lows of $0.231 after the FDA placed a partial clinical hold…
CytoDyn Inc (OTCMKTS: CYDY) continues to move steadily higher in recent trading since hitting lows of $0.231 after the FDA placed a partial clinical hold on the Company’s HIV program and a full clinical hold on its COVID-19 program in the United States. CYDY was one of the biggest runners of 2020 skyrocketing from pennies to $10 per share and MIcrocapdaily covered the stock regularly back in those exciting times. Since than CYDY has been downward bound, first suffering from the Citron short attack and more recently the March 30 drop after the FDA hold. Further, CytoDyn elected to pause its Brazil COVID-19 trials pending results from its previously scheduled data safety monitoring committee meeting and is in the process of reevaluating the timing of its HIV BLA resubmission. CYDY saw further declines after the Company’s CEO and registered public accounting firm, Warren Averett LLC, both resigned.
On May 23 CYDY reached a non-cash settlement with its former Chief Medical Officer, Dr. Richard Pestell. The Company will release to Dr. Pestell 8.3 million shares of CYDY held in escrow, transfer to Dr. Pestell the assets acquired from ProstaGene LLC and subsequently written-off by the Company and issue a warrant at an exercise price of $0.37 per share to Dr. Pestell for seven million shares of the Company’s common stock. Dr. Pestell and the Company are also exploring ways in which Dr. Pestell can reengage with the Company to help realize Leronlimab’s full potential in oncology. This is an important step forward for CytoDyn as any potential suitor would want the current management to clear the deck of lawsuits before initiating a buyout or partnership. Also, an all-stock settlement shows a lot of faith in the Company from Dr. Pestell who make come back. At this point Cytodyn must find a sponsor or partner to get Leronmilab back on track for HIV.
The underlying science of Leronmilab has not changed; leronlimab has demonstrated significant potential to attack a number of diseases including cancer, and HIV. Considering how fast CYDY dropped the bounce potential here is significant and when CYDY does make a definitive move northbound the stock could make rapid gains in a very shorty time period. Management remains hopeful the FDA will review the case and stop the hold of Leronlimab.
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CytoDyn Inc (OTCMKTS: CYDY) is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn is studying leronlimab in multiple therapeutic areas, including infectious disease, cancer, and autoimmune conditions.
In January Cytodyn reported positive results from the 350 mg weekly dose of its Phase 2 NASH clinical trial. The trial was conducted in two parts. Part 1 compared a 700 mg weekly dose and placebo in a double-blind randomized manner and Part 2 evaluated a 350 mg weekly dose as an open label study compared to the same placebo blinded arm. Results of the topline report will be announced when available.
The pre-clinical and clinical development of PRO 140 was led by Progenics Pharmaceuticals, Inc. through 2011. The Company acquired the asset from Progenics in October 2012. In February 2018, CYDY announced it had met the primary endpoint in its Phase 3 trial for leronlimab as a combination therapy with HAART for highly treatment-experienced HIV patients and first submitted the non-clinical portion of the Company’s Biologics License Application (“BLA”) to the FDA in March 2019.
— TL (@THL99999) May 21, 2022
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Cytodyns current business strategy is to resubmit its BLA to the FDA as soon as possible, to finalize with the FDA our submitted protocol for a pivotal Phase 3 clinical trial with leronlimab as a monotherapy for HIV patients, to seek emergency use authorization and approval for leronlimab as a potential therapeutic benefit for COVID-19 patients with mild-to-moderate, severe-to-critical, and long-haulers indications in the U.S., Brazil, and other countries, to advance the Company’s clinical trials with leronlimab for various forms of cancer, including, among others, the Phase 2 clinical trial for metastatic triple-negative breast cancer and Phase 2 basket trial for 22 solid tumor cancers, to complete the Phase 2 trial for liver fibrosis associated with nonalcoholic steatohepatitis (“NASH”), and to explore other cancer and immunologic indications for leronlimab.
On May 23 CYDY announced it has reached a non-cash settlement with its former Chief Medical Officer, Dr. Richard Pestell, concerning an ongoing legal dispute related to his former employment with the Company.
Under the terms of the agreement, the parties will release each other of all claims, and the Company will release to Dr. Pestell 8.3 million shares of the Company’s common stock held in escrow, transfer to Dr. Pestell the assets acquired from ProstaGene LLC and subsequently written-off by the Company and issue a warrant at an exercise price of $0.37 per share to Dr. Pestell for seven million shares of the Company’s common stock. Dr. Pestell and the Company are also exploring ways in which Dr. Pestell can reengage with the Company to help realize leronlimab’s full potential in oncology. CytoDyn regrets Dr. Pestell’s departure from the Company and the subsequent public statements made by its former CEO about Dr. Pestell.
Dr. Pestell has published more than 600 works, is the most frequently cited scientist in the field of cell-cycle control and was appointed an Officer of the Order of Australia in the 2019 Queen’s Birthday Honours for distinguished service to medicine and medical education. He has served on editorial boards of six journals, was the Director of two NCI-designated Cancer Centers and has founded several biotechnology companies. He serves as an advisor and reviewer for a number of domestic and international research centers, including NCI cancer centers.
$CYDY 8-K CytoDyn (23 May, 4:03pm)
— Docoh Feed (@investor_feed) May 23, 2022
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Currently trading at a $226 million market valuation CYDY is an SEC filer and is fully reporting OTCQB. The Company has close to $100 million in assets and about that in debt. At current price levels CYDY is worth a close look; CYDY was one of the biggest runners of 2020 skyrocketing from pennies to $10 per share. While there are plenty of ricks not to mention the CEO and accounting firm resigning CYDY is moving northbound now and looks to be coming back. The underlying science has not changed; Leronlimab has demonstrated significant potential to attack a number of diseases including cancer and HIV. Considering how fast CYDY dropped the bounce potential here is significant and when CYDY does make a definitive move northbound the stock could make rapid gains in a very shorty time period. Management remains hopeful the FDA will review the case and stop the hold of Leronlimab. We will be updating on CYDY when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with CYDY.
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Disclosure: we hold no position in CYDY either long or short and we have not been compensated for this article.
The post CytoDyn Inc (OTCMKTS: CYDY) On the Comeback Trail (HIV Leronlimab Update) first appeared on Micro Cap Daily.emergency use authorization covid-19 treatment fda clinical trials therapy brazil
Immigration Disappears From Kamala Harris’ Public Schedule
Immigration Disappears From Kamala Harris’ Public Schedule
Authored by Philip Wegmann via RealClear Politics (emphasis ours),
It was her…
Authored by Philip Wegmann via RealClear Politics (emphasis ours),
It was her first overseas trip, and Vice President Harris, recently deputized to address what the White House calls “the root causes of migration,” was in Guatemala trying to break through with a simple message. “Do not come,” Harris told would-be migrants last June. “Do not come. The United States will continue to enforce our laws and secure our borders.”
They did not listen, or if any migrants did hear Harris last year, many ignored her message. Just last month, according to U.S. Customs and Border Patrol, 234,088 migrants were apprehended at the southern border, the highest mark ever recorded.
Asked that same month if President Biden had confidence in Harris and her ability to handle the situation, then-White House Press Secretary Jen Psaki replied, “he absolutely does.” But as the flow of migrants accelerates across the southern border, immigration has disappeared from the vice president’s public schedule.
A compilation of that schedule by the Los Angeles Times, reviewed by RealClearPolitics, shows that Harris has not hosted an immigration-specific event since last summer. The last one, a meeting with Asian American, Native Hawaiian, and Pacific Islander leaders in the White House last August, touched briefly on immigration.
White House officials dispute any characterization that Harris’ public schedule tells the whole story. “The vice president continues to lead implementation of the Root Causes Strategy and has been engaging with Cabinet and other Administration officials on this effort,” Harris’ Press Secretary Kirsten Allen told RCP.
Addressing the challenge remains part of the vice president’s policy portfolio. She leads top-level meetings that are not always made public, and she has taken point in diplomatic efforts in the region. For instance, it was Harris who traveled to Honduras for the inauguration of President Xiomara Castro in January. Administration officials hoped to find a new ally in that executive, someone who would help stem the flow of the millions of people heading north through Central America to the southern border. According to an official White House readout, Harris and Castro discussed “a broad range of issues.” Among them migration, but also coronavirus and the economy as well as corruption and gender-based violence.
Despite those efforts, the influx has not slowed, and Biden is expected to end enforcement of Title 42, the pandemic policy that allowed Border Patrol to turn away hundreds of thousands of migrants on public health grounds. Warnings from some Democrats in border states, including Texas Rep. Henry Cuellar, have gone unheeded.
The Department of Homeland Security is bracing for more record-breaking numbers at the border, and NBC News reports that there is concern in the department that they won’t have enough funding to address a surge if Title 42 is lifted, compounding a challenge that Biden has faced since the beginning of his presidency.
As the number of interdictions started to rise and chaotic images from the southern border flooded cable news, concern grew, even among Democrats. Biden’s own pollsters, the New York Times reported, warned that the issue was “a growing vulnerability." Biden still insisted that he could get the situation under control, albeit with divine intervention.
“Is there a crisis at the border?” RCP asked the president as he walked out of the East Room of the White House after a speech last March.
“No,” Biden replied over his shoulder. “We’ll be able to handle it,” he said while walking side-by-side with Harris. “God willing.”
Two weeks later, the Associated Press reported at the time, Biden tapped Harris to lead the administration efforts to tackle the migration challenge at the southern border and work with Central American nations to address root causes of the problem. Republicans were eager to assign blame and dubbed Harris “border czar.”
The vice president rejected that framing and sought to clarify her mission. As the White House press secretary explained to reporters last March, Harris “will be helping lead that effort, specifically the root causes – not the border,” admitting that there has been “some confusion over that.”
The president was also confused: When Biden and Harris met with the Congressional Black Caucus in April that year, he praised his vice president, saying she would do “a hell of a job” handling immigration, according to a new book by New York Times’ reporters Jonathan Martin and Alexander Burns. But Harris corrected him then and there, the two write. “Excuse me,” she said, “it's the Northern Triangle – not immigration.”
Biden eventually clarified the mission. “It’s not her full responsibility,” he later told reporters, but “when she speaks, she speaks for me.”
Whether she wanted the job or not, Harris embraced the challenge. She has made three trips to the region, and she traveled to the southern border to hear directly from Border Patrol. The vice president has met both with law enforcement and migrant groups, stressing all the while that the question “cannot be reduced to a political issue.”
Politics were there from the beginning though, and some feared that deputizing Harris to tackle such a mammoth challenge ran the risk of unfairly saddling her with a thankless mission for which there is no easy solution. “She is qualified to do the job,” Chuck Rocha told RCP of Biden’s decision to turn this part of his policy portfolio over to his vice president. Rocha helmed Latino outreach for Sen. Bernie Sanders in both of that candidate’s presidential bids, and Rocha credited Harris for being “a staunch advocate of the progressive wing of the immigration movement.”
All the same, Rocha warned last year that expectations should be tempered: “It has been an issue that we have been trying to fix for generations, one that I don’t think any one person can totally solve.”
Biden has called on Congress to take up comprehensive immigration reform since he got to the White House. There is no bipartisan appetite on Capitol Hill for the bill that he sent to Congress on his first day in office. The administration has subsequently been left to its own devices, and Harris released a 20-page plan last July to address the problem.
“We will build on what works, and we will pivot away from what does not work,” Harris wrote in an introduction to the plan that focuses on creating partnerships with Northern Triangle countries to combat corruption, violence, and poverty.
“It will not be easy, and progress will not be instantaneous,” the vice president warned, “but we are committed to getting it right.” Biden should know. He was deputized by then-President Obama to deal with a similar mission amid an earlier surge of migrants, many of them unaccompanied children. On a tour of Central and South American nations in 2014, he offered U.S. help to root out corruption, provide economic opportunity, and ensure safety in the Northern Triangle nations.
“We have to deal with the root causes,” Vice President Biden told reporters gathered for a press conference in the residence of the U.S. ambassador to Guatemala, echoing the exact phrase his administration now uses eight years later.
Biden understands the challenge, and that tackling it without help from Congress is arduous and thankless, if not impossible.
“I said when we became a team and got elected, that the vice president was going to be the last person in the room,” he joked last March when he announced that Harris would helm the mission. “She didn’t realize that means she gets every assignment.”
“I gave you a tough job, and you’re smiling, but there’s no one better capable of trying to organize this for us,” the president continued after the levity. The vice president didn’t flinch. She thanked him “for having confidence in me.” Then Harris added, “there’s no question that this is a challenging situation.”
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