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Revive Therapeutics Data Access Plan Approved By The FDA; Partial Unblinded Data In Company Hands

Revive Therapeutics Ltd. (CNSX: RVV) (OTCMKTS: RVVTF) moved closer towards potential endpoint change in their Phase 3 clinical trial to evaluate the…

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Revive Therapeutics Ltd. (CNSX: RVV) (OTCMKTS: RVVTF) moved closer towards potential endpoint change in their Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine to treat COVID-19. The FDA officially approved the company’s Data Access Plan (DAP) to allow for the unblinding of the pre-dose selection data to a designated company statistician. This marks the final regulatory hurdle between Revive reviewing data and determining whether to pivot to revised trail endpoints.

The news was announced after market open on Friday, in what has become a recent deviation from customary pre-market morning releases. In it, Revive Therapeutics disclosed that with DAP approval in-hand, it will now proceed to unblind the pre-dose selection data to potentially support the amended study protocol with the new primary efficacy endpoints. This will involve reviewing data from the first 210 patients and determining whether targeting symptom reduction gives the trial the best chance to succeed.

With the rise of the virulent, yet less dangerous Omicron and BA.2 variants, the original mission to reduce death and hospitalization has evolved. However, there remains an important need for an oral COVID therapeutic that can provide symptom relief and potentially mitigate another wave of disruptive economic shutdowns.

As BNN Bloomberg reported on June 24, COVID infection rates are rising again in the UK and across much of Europe—driven by newer versions of the omicron variant—amid concerns that another wave will disrupt businesses and add to pressure on health systems. New outbreaks elsewhere are causing growing absences from workplaces and worsening labor shortages. In Germany, Deutsche Lufthansa AG is canceling 3,100 flights, adding to Europe’s travel chaos as the summer vacation period gets under way.

Reports of worldwide COVID case outbreaks have been common throughout 2022. For example, new cases in South Korea rose from under 5000 per day in early January to a surge of 621,328 cases per day, as reported by The Guardian on March 17. It also brought along with it record fatalities, with 429 people succumbing to the illness on that day.

Broadly speaking, the scientific community and state leaders expect more such outbreaks in the foreseeable future—including U.S. president Joe Biden. This past week, president Biden spoke at the White House about the need for more funding to fight Covid-19, stating that a “second pandemic” was coming.

Revive Therapeutics COVID Trial Nears An Inflection Point

According to the Merriam-Webster dictionary, an inflection point is defined as “a moment when significant change occurs or may occur.” This simple definition applies aptly to the current dynamics of Revive Therapeutics COVID trial story.

With unblinded data now in-possession, Revive is positioned to make an informative decision on the applicability of potential endpoint change. Should it move forward and decide that the data justifies this conclusion, and pending FDA review and approval of such changes, the trial’s Data Safety and Monitoring Board could meet shortly thereafter to unblind the study entirely, paving the way for potential Emergency Use Authorization submission.

And given the way leading oral COVID therapeutic Paxlovid (Pfizer) is performing, it’s a reasonable assumption that the FDA is keen on bringing new drugs into the marketplace.

The ineffectiveness of Paxlovid recently came into focus when Pfizer halted enrollment into the EPIC-SR trial evaluating Paxlovid in standard-risk patients due to lack of efficacy. The phase 2/3 trial failed to prove that the antiviral treatment reduced the relative risk of contracting COVID-19 and associated symptoms. This came in addition to a May 24 warning issued by the Center for Disease Control and Prevention (CDC) which advised that a rebound in COVID symptoms can occur after taking Paxlovid, approved for symptoms reduction in the high-risk population.  

With questions regarding the efficacy and long-term viability of antiviral medications in-focus, Bucillamine may have a legitimate shot at becoming a frontline therapeutic option. With a differentiated mode-of-action reliant on squelching oxidative stress and inflammation (along with some purported antiviral and anti-spike protein binding characteristics), Bucillamine is treating symptoms of COVID as opposed to trying to eradicate a virus that is constantly mutating.

Regardless, the quality of trial data will determine Bucillamine’s success or failure in the current Phase 3 study. By allowing the company to view partial unblinded data before making an endpoint decision, we can only surmise that the FDA is giving Revive the best possible chance to succeed. For the first time in almost two years since the trial was initiated, a potential endgame is close at hand.

The post Revive Therapeutics Data Access Plan Approved By The FDA; Partial Unblinded Data In Company Hands appeared first on The Dales Report.

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International

Apple Reportedly Shifting Watch And MacBook Production To Vietnam

Apple Reportedly Shifting Watch And MacBook Production To Vietnam

Wary of soaring tensions surrounding out-of-favor countries like China,…

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Apple Reportedly Shifting Watch And MacBook Production To Vietnam

Wary of soaring tensions surrounding out-of-favor countries like China, multinational corporations such as Apple are diversifying production to places with less geopolitical risk.

Nikkei Asia spoke to three sources with direct knowledge of Apple's plans to shift Watch and MacBook production out of China to Vietnam for the first time. 

Apple suppliers Luxshare Precision Industry and Foxconn have already piloted a production run of the Watch in northern Vietnam. 

The move by Apple is a further win for the Southeast Asian country as it already produces iPads and AirPods. 

Two sources told Nikkei Asia that Apple had requested suppliers to set up a MacBook test production line in Vietnam. They said progress in constructing laptop production in the country has been "slow, partly due to pandemic-related disruptions but also because notebook computer production involves a larger supply chain."  

"AirPods, Apple Watch, HomePod and more ... Apple has big plans in Vietnam, apart from iPhone manufacturing," one of the people with direct knowledge of Apple's plans said. "The components for MacBooks have become more modularized than in the past, which makes it easier to produce the laptops outside of China. But how to make it cost-competitive is another challenge."

This trend is called "friendshoring." While it's a play on "offshoring," this isn't about companies moving operations back to the US and Europe, but rather seeking foreign alternatives that retain the benefit of low labor costs but with less international controversy. 

Apple's production diversification comes as the US and China already had an increasingly adversarial relationship before House Speaker Nancy Pelosi's visit to Taiwan sparked anger with Beijing. The fact is, geopolitical and trade war tensions aren't going away anytime soon and will only push Apple further away from China. Though reshoring production to the US is unfeasible because of labor costs, maybe robotics can offset some of those costs or perhaps set up shop in Mexico, where there's abundant cheap labor and healthy demographics. 

A recent Rabobank analysis of friendshoring showed that chief beneficiaries would include countries like Vietnam, India, Brazil, Bangladesh, Indonesia, Mexico, Turkey, Egypt, and South Africa.

Apple's Tim Cook appears to have learned a valuable lesson this year that high exposure of supply chains to China during Beijing's zero-Covid policies and worsening geopolitical tensions with the West is a dangerous cocktail, and the need to diversify production in a trend dubbed friendshoring is essential for survival in a multi-polar world. 

Tyler Durden Wed, 08/17/2022 - 18:30

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International

Apple Reportedly Shifting Apple Watch And MacBook Production To Vietnam

Apple Reportedly Shifting Apple Watch And MacBook Production To Vietnam

Wary of soaring tensions surrounding out-of-favor countries like China,…

Published

on

Apple Reportedly Shifting Apple Watch And MacBook Production To Vietnam

Wary of soaring tensions surrounding out-of-favor countries like China, multinational corporations such as Apple are diversifying production to places with less geopolitical risk.

Nikkei Asia spoke to three sources with direct knowledge of Apple's plans to shift Watch and MacBook production out of China to Vietnam for the first time. 

Apple suppliers Luxshare Precision Industry and Foxconn have already piloted a production run of the Watch in northern Vietnam. 

The move by Apple is a further win for the Southeast Asian country as it already produces iPads and AirPods. 

Two sources told Nikkei Asia that Apple had requested suppliers to set up a MacBook test production line in Vietnam. They said progress in constructing laptop production in the country has been "slow, partly due to pandemic-related disruptions but also because notebook computer production involves a larger supply chain."  

"AirPods, Apple Watch, HomePod and more ... Apple has big plans in Vietnam, apart from iPhone manufacturing," one of the people with direct knowledge of Apple's plans said. "The components for MacBooks have become more modularized than in the past, which makes it easier to produce the laptops outside of China. But how to make it cost-competitive is another challenge."

This trend is called "friendshoring." While it's a play on "offshoring," this isn't about companies moving operations back to the US and Europe, but rather seeking foreign alternatives that retain the benefit of low labor costs but with less international controversy. 

Apple's production diversification comes as the US and China already had an increasingly adversarial relationship before House Speaker Nancy Pelosi's visit to Taiwan sparked anger with Beijing. The fact is, geopolitical and trade war tensions aren't going away anytime soon and will only push Apple further away from China. Though reshoring production to the US is unfeasible because of labor costs, maybe robotics can offset some of those costs or perhaps set up shop in Mexico, where there's abundant cheap labor and healthy demographics. 

A recent Rabobank analysis of friendshoring showed that chief beneficiaries would include countries like Vietnam, India, Brazil, Bangladesh, Indonesia, Mexico, Turkey, Egypt, and South Africa.

Apple's Tim Cook appears to have learned a valuable lesson this year that high exposure of supply chains to China during Beijing's zero-Covid policies and worsening geopolitical tensions with the West is a dangerous cocktail, and the need to diversify production in a trend dubbed friendshoring is essential for survival in a multi-polar world. 

Tyler Durden Wed, 08/17/2022 - 18:30

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Economics

Reduced myocardial blood flow is new clue in how COVID-19 is impacting the heart

Patients with prior COVID may be twice as likely to have unhealthy endothelial cells that line the inside of the heart and blood vessels, according to…

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Patients with prior COVID may be twice as likely to have unhealthy endothelial cells that line the inside of the heart and blood vessels, according to newly published research from Houston Methodist. This finding offers a new clue in understanding covid-19’s impact on cardiovascular health.

Credit: Houston Methodist

Patients with prior COVID may be twice as likely to have unhealthy endothelial cells that line the inside of the heart and blood vessels, according to newly published research from Houston Methodist. This finding offers a new clue in understanding covid-19’s impact on cardiovascular health.

In a new study published today in JACC: Cardiovascular Imaging, Houston Methodist researchers examined the coronary microvasculature health of 393 patients with prior covid-19 infection who had lingering symptoms. This is the first published study linking reduced blood flow in the body and COVID-19.

Using a widely available imaging tool, called positron emission tomography (PET), researchers found a 20% decrease in the ability of coronary arteries to dilate, a condition known as microvascular dysfunction. They also found that patients with prior COVID-19 infection were more likely to have reduced myocardial flow reserve – and changes in the resting and stress blood flow – which is a marker for poor prognosis and is associated with a higher risk of adverse cardiovascular events.

“We were surprised with the consistency of reduced blood flow in post covid patients within the study,” said corresponding author Mouaz Al-Mallah, M.D., director of cardiovascular PET at Houston Methodist DeBakey Heart and Vascular Center, and president elect of the American Society of Nuclear Cardiology. “The findings bring new questions, but also help guide us toward further studying blood flow in COVID-19 patients with persistent symptoms.”

Dysfunction and inflammation of endothelial cells is a well-known sign of acute Covid-19 infection, but little is known about the long-term effects on the heart and vascular system. Earlier in the pandemic, research indicated that COVID-19 could commonly cause myocarditis but that now appears to be a rare effect of this viral infection.

A recent study from the Netherlands found that 1 in 8 people had lingering symptoms post-covid. As clinicians continue to see patients with symptoms like shortness of breath, palpations and fatigue after their recovery, the cause of long covid is mostly unknown.

Further studies are needed to document the magnitude of microvascular dysfunction and to identify strategies for appropriate early diagnosis and management. For instance, reduced myocardial flow reserve can be used to determine a patient’s risk when presenting with symptoms of coronary artery disease over and above the established risk factors, which can become quite relevant in dealing with long Covid.

Next steps will require clinical studies to discover what is likely to happen in the future to patients whose microvascular health has been affected by COVID-19, particularly those patients who continue to have lingering symptoms, or long COVID.

This work was supported, in part, by grants from the National Institutes of Health under contract numbers R01 HL133254, R01 HL148338 and R01 HL157790.

———————–

For more information: Coronary microvascular health in patients with prior COVID-19 infection. JACC: Cardiovascular Imaging. (online Aug. 16, 2022) Ahmed Ibrahim Ahmed, Jean Michel Saad, Yushui Han, Fares Alahdab, Maan Malahfji, Faisal Nabi, John J Mahmarian, John P. Cook, William A Zoghbi and Mouaz H Al-Mallah. DOI: www.doi.org/10.1016/j.jcmg.2022.07.006

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