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NYC To Reopen Indoor Dining; Dr. Fauci Says Vaccine Makers Must Keep Up With Mutating Virus: Live Updates

NYC To Reopen Indoor Dining; Dr. Fauci Says Vaccine Makers Must Keep Up With Mutating Virus: Live Updates

Summary:

NYC to reopen indoor dining on Valentine’s day
Germany bars visitors from areas where COVID mutations identified
Dr. Fauci..

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NYC To Reopen Indoor Dining; Dr. Fauci Says Vaccine Makers Must Keep Up With Mutating Virus: Live Updates

Summary:

  • NYC to reopen indoor dining on Valentine's day
  • Germany bars visitors from areas where COVID mutations identified
  • Dr. Fauci warns mutant COVID strains to be expected
  • EU regulators say vaccines safe for elderly
  • JNJ chief scientific officer says will apply for emergency approval in US
  • WHO team finally visits Wuhan
  • Tokyo and surrounding area hint at closures of bars, restaurants
  • Thailand's tourism industry hit
  • India new cases continue to decline
  • China reports 52 new infections

* * *

Update (1145ET): With even the President of France questioning whether vaccines from AstraZeneca (and other western vaccine makers) are even worth taking now, Dr. Anthony Fauci has once again stepped in to give the American public a lecture in epidemiology, per the AP.

Today's subject: Viral mutations. So long as the virus keeps spreading, there will continue to be mutations, Dr. Fauci said.

Still, after insisting the mutations wouldn't cause any problems with the first round of vaccines, Fauci said during a White House briefing that vaccine-makers were already hard at work making new versions of the vaccines that are effective against the mutated COVID strains. "This was a wake up call for all of us," Dr. Fauci said.

"You can be almost certain that as long as there is a lot of virus circulating in the community, there will be the evolution of mutants, because that is what viruses do," Dr. Fauci said.

The AP reported that Dr. Fauci was speaking as worries about mutated COVID strains arriving in the US were intensifying. As we noted yesterday, the first known cases of the South African COVID mutation have been identified in South Carolina, and officials believe that the "variant" could be spread far and wide at this point since the two patients have no connection.

Finally, Gov Andrew Cuomo has just confirmed that indoor dining will reopen in NYC on Valentine's Day (Feb. 14), while also releasing the latest COVID data (which, like the broader US, show hospitalizations falling).

Meanwhile, as the EU approves the AstraZeneca vaccine amid a major dispute over supplies (as some factories run by AZ have had unspecified difficulties meeting production targets), Germany is barring entry for travelers from areas where COVID mutations were identified (so far that's South Africa and the UK).

* * *

Regulators in Germany yesterday warned that the Pfizer-BioNTech vaccine shouldn't be administered to minors or those older than 64. It appears the comments have sparked some kind of a battle between European regulators, as the European Medicines Agency, the top medical regulator in the EU, tells the public that the Pfizer-BioNTech vaccine is safe for older people, as a Europe-wide review found, with no link between the shot and any kind of enhanced risk.

A Europe-wide review found no link between the shot and the deaths of elderly people exposed to the vaccine. However, the EMA review found no new side effects.

In the US, JNJ released its first COVID vaccine data, while its chief scientific officer, Dr. Paul Stoffels, appeared on CNBC to confirm that the company plans to apply for emergency-use approval in the US immediately, and hopes to have supplies of the vaccine being doled out within weeks.

But nevertheless, new cases and hospitalizations are already starting to decline, as new cases reported in the US were under 156K yesterday, while hospitalizations fell by 3K, with big declines across the major outbreak states.

In other news, the WHO team finally made its way to Wuhan on Friday, and visited the Hubei Provincial Hospital of Integrated Chinese and Western Medicine, where many early cases of the virus were located.

Zhang Jixian, director of the hospital's department of respiratory and critical care, has been described by Chinese state media as the first to report the virus after examining an elderly couple in late 2019 whose CT scans showed differences from typical pneumonia.

With vaccines a big topic again Friday morning following the Novavax news Thursday night and the JNJ news Friday morning, WHO's CoVax program said it plans to ship enough vaccines to cover 3% of the population of the developing world as of Friday.

In Japan, the governors of Tokyo and its three neighboring prefectures of Kanagawa, Chiba and Saitama have agreed to consider asking restaurants and bars to shut down operations if the central government decides to extend the monthlong COVID-19 state of emergency beyond Feb. 7. The local governments are considering asking them to close early. Tokyo just reported 868 new infections, down from 1,064 a day earlier, as the capital tries to slow the spread of the virus.

Thailand's tourism industry is now being hit with a number of business closures and job losses as it suffers through yet another wave of COVID-19 infections while pleading with the government for aid. At least 1MM workers in the country's hospitality sector have been laid off so far, according to one trade group.

India, meanwhile, reported 18.9K cases over the past 24 hours, up from 11.7K the previous day, bringing the country total to 10.72MM. It also reported 163 deaths due to the virus, bringing the country's total confirmed deaths to 154K. Meanwhile, India has vaccinated about 2.93MM people against COVID-19 since it started vaccinations on Jan. 16.

Here's some more COVID-19 news from overnight:

  • The Serum Institute of India, the world's biggest vaccine maker, has applied with local authorities for permission to conduct a small domestic trial of Novavax's COVID-19 vaccine (Source: Nikkei).
  • South Korea has delayed until Sunday any easing of social distancing measures because outbreaks involving mission schools are threatening to undermine efforts to keep new infections under control ahead of the Lunar New Year holidays (Source: Nikkei).
  • China reports 52 new infections for Thursday, down from 54 cases a day earlier. Of the new ones, 36 were locally transmitted infections. Asymptomatic cases, which China does not classify as confirmed COVID-19 cases, rose to 42 from 28 a day earlier (Source: Nikkei).

* * *

As we first reported yesterday, now that cases of the South African variant have found their way to the US, there's about to be a lot more talk about the 501. V2 variant/mutant, especially now that the latest vaccine data from JNJ has confirmed what Moderna's follow-up study appeared to suggest: vaccines aren't nearly as effective against the mutating virus as public health officials have promised.

Tyler Durden Fri, 01/29/2021 - 12:05

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Monkeypox cases are rising. Should we be worried?

The World Health Organization has said the current outbreak of monkeypox is the largest ever recorded outside sub-Saharan
The post Monkeypox cases are…

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The World Health Organization has said the current outbreak of monkeypox is the largest ever recorded outside sub-Saharan Africa, with cases rising above the 100-mark a few days ago and the UK top of the table with 56 as of yesterday.

Top of the list of concerns is how the virus – which does not spread easily between humans and requires skin-to-skin contact – is spreading so quickly in so many countries in Europe, the Americas and Australia where the disease is not endemic.

There is speculation that monkeypox may be being spread between sexual partners, even though it is not normally considered a sexually-transmitted infection. Thankfully, there have been no deaths reported so far, although the WHO notes monkeypox has a fatality rate of between 3% and 6%.

While health authorities are on alert, the WHO said it thinks the outbreak can be contained and that the overall risk to the population remains low. It also stressed there is no evidence that a viral mutation is responsible for the unusual pattern of infections.

Monkeypox is considered less likely to mutate quickly because it is a DNA virus rather than an RNA virus like influenza or COVID-19.

Several countries including Belgium and the UK are already advising a three-week quarantine period for anyone who contracts the virus and their close contacts.

The increasing case numbers in the current monkeypox outbreak are certainly concerning,” commented Dr Charlotte Hammer, an expert in emerging infectious diseases based at the University of Cambridge in the UK.

“It is very unusual to see community transmission in Europe – previous monkeypox cases have been in returning travellers with limited ongoing spread. However, based on the number of cases that were already discovered across Europe and the UK in the previous days, it is not unexpected that additional cases are now being and will be found, especially with the contact tracing that is now happening.”

Vaccines and drugs are available

Meanwhile, attention is now being turned to other measures to control the outbreak, including the use of vaccines against smallpox – a related virus – in a ‘ring vaccination’ approach designed to control the spread among contacts.

Vaccines used during the smallpox eradication programme can provide around 85% protection against monkeypox, according to the WHO, which notes that one newer vaccine – Bavarian Nordic’s Jyneos – has been approved by the FDA for prevention against both viruses.

There’s also a licensed antiviral drug for monkeypox. SIGA Technologies’ oral drug Tpoxx (tecovirimat) is approved for smallpox, monkeypox and cowpox in Europe, and in the US and Canada for smallpox, although it can be used off-label for the other disease. The US FDA also approved a new intravenous form of the drug last week.

The WHO says there is no need for widespread vaccination, as other control measures like isolation of patients should be enough to curb the spread and in any case supplies of vaccines are limited.

Monkeypox causes symptoms similar to but milder than smallpox, typically beginning with fever, headache, muscle aches and exhaustion. It is transmitted to people from various wild animals, such as rodents and primates, and is usually a self-limited disease with symptoms lasting from two to four weeks.

In 2003, the US experienced an outbreak of monkeypox, which was the first time human monkeypox was reported outside of Africa. The Centers for Disease Control and Prevention (CDC) is making some Jyneos vaccine reserves available for close contact inoculations, including healthcare workers tending to patients.

The UK Health Security Agency (UKHSA) said yesterday it had identified 36 additional cases of monkeypox in England, and that vaccination of high-risk contacts of cases is already underway.

“A notable proportion of recent cases in the UK and Europe have been found in gay and bisexual men so we are particularly encouraging these men to be alert to the symptoms,” said the agency’s chief medical advisor Dr Susan Hopkins.

“Because the virus spreads through close contact, we are urging everyone to be aware of any unusual rashes or lesions and to contact a sexual health service if they have any symptoms.”

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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…

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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.”

Tyler Durden Tue, 05/24/2022 - 02:00

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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…

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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.  

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CYDY

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. 

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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.

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