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Friday, September 23, 2022

Cassava Sciences Shares Falter on Response to SEC Probe Report

 Shares of Cassava Sciences Inc. fell more than 15% Friday, erasing much of Thursday's big gains, after the biotechnology company downplayed a published report that the Securities and Exchange Commission is preparing to close an investigation into claims of study manipulation.

The Austin, Texas, company said in an SEC filing that it hasn't received any termination letter or the like from any government agency regarding any requests for corporate information and documents.

Cassava last November disclosed that undisclosed government agencies had made confidential requests for information and documents, and the company on Friday said those requests remain confidential.

The Wall Street Journal, citing people familiar with the matter, reported in November that the SEC was looking into claims that Cassava had manipulated research results of its experimental drug for Alzheimer's disease.

On Thursday, Seeking Alpha, citing a document it said was obtained through a request under the Freedom of Information Act, or FOIA, reported that the SEC was closing its case, sending Cassava shares up nearly 36% during Thursday's trading session.

Cassava on Friday said it is "unable to establish the legitimacy" of the communications purportedly sent from a government agency following a FOIA request, and that it "expressly disclaims any obligation to respond to any reports or rumors related to the topic of FOIA."

Cassava shares were recently changing hands at $42.58, down nearly 17%.

https://www.marketscreener.com/quote/stock/CASSAVA-SCIENCES-INC-56537199/news/Cassava-Sciences-Shares-Falter-on-Response-to-SEC-Probe-Report-41848083/

Dems ‘demonizing’ valuable energy sources proves they don't care about climate: Holtz-Eakin

 During an interview on "Cavuto: Coast to Coast" Friday, former Congressional Budget Office director and AAF President Douglas Holtz-Eakin slammed the Biden administration's approach to climate change, arguing their policies do not align with the nation's "broader social goals."

DOUGLAS HOLTZ-EAKIN: I have been baffled by this administration's approach to climate change. If you care about climate, you care about what comes out, you don't demonize what fuels go in. And their strategy is built on taking valuable energy sources off the table. That's not a particularly rational strategy. All of the deep research on the economics of climate change show that natural gas and other fossil fuels would be in the mix for decades to come, even as you'd made the transition to cleaner fuels and controlled the emissions from the economy. 

So that's the research. This strategy is not based on anything approaching the research reality. It's a very risky bet on solar and wind. And it doesn't make sense from the perspective of the broader social goals that we have sustained rises in standard of living, sustained ability to get people to work and the clean environment. You can do all those at the same time. But this strategy doesn't allow it. 

https://www.foxbusiness.com/energy/democrats-demonizing-valuable-energy-sources-proves-dont-care-climate-douglas-holtz-eakin

Admin watching stock market closely as equities drop: spokes

 The Biden administration is watching the stock market and other indicators closely as equities tumbled on Friday, a White House spokeswoman said. "The stock market, as you've heard us say many times, is just one measure of the economy," said press secretary Karine Jean-Pierre. "We are watching, always watching, these different indicators closely, including the stock market," she told reporters at a daily briefing. Jean-Pierre added that laws signed by Biden including the Inflation Reduction Act are designed to ensure that "we don't leave anybody behind."

https://www.morningstar.com/news/marketwatch/20220923554/biden-administration-watching-stock-market-closely-as-equities-drop-spokeswoman-says

White House condemns World Bank chief Malpass’s climate comments

 World Bank President David Malpass on Friday said none of the global development bank’s shareholders have asked him to resign despite a wave of criticism this week after he declined to say whether he accepts the scientific consensus on global warming.

Malpass addressed the concerns on Thursday in an interview with CNN International and in a separate note to staff, saying it was clear that human activity is fueling climate change and defending his record at the helm of the development bank.

On Friday, he told Politico it was “unfortunate” that he responded as he did during an event on Tuesday: “When asked, ‘Are you a climate denier?’ I should have said no. … I really wasn’t prepared and didn’t do my best job in answering that charge.”

Malpass, a Republican nominated by former President Donald Trump, said he was caught off guard by the question because “no one’s said that other than (former Democratic Vice President) Al Gore, and it was pretty much off topic.”

Malpass, whose five-year term is due to end in spring 2024, reiterated on Friday that he believed human activity caused climate change, while defending what he called the bank’s “forceful leadership” on climate change and its role as the leading financier of climate change projects.

Asked if any shareholder had asked him to resign over the issue, Malpass said, “No, none have.”

In fact, he said, shareholders had been strongly supportive of him and the work of the World Bank, citing “massive” support for its creation of a new pandemic response fund and the recent replenishment of the International Development Association facility for the world’s poorest countries.

Malpass has long faced criticism from climate advocates, who renewed calls on President Joe Biden to replace him. His remarks at a climate event hosted by the New York Times on Tuesday also rekindled concerns about the bank’s lack of a deadline to stop funding fossil fuels.

Speaking onstage during Tuesday’s panel on climate finance, Malpass was asked several times whether he believes the “manmade burning of fossil fuels is rapidly and dangerously warming the planet.” He tried to dodge the question before saying: “I don’t even know. I’m not a scientist.”

“That wasn’t a good phrase for me to use,” Malpass said on Friday. “We have a lot of input from the global scientific community … We interact with scientists.”

The United States, the largest shareholder in the bank, on Wednesday said it expected the bank to be “a full partner” in fighting climate change, but stopped short of voicing more forceful criticism of Malpass.

The president of the United States traditionally nominates World Bank presidents, subject to confirmation by the bank’s board. Treasury declined comment when asked if it supported a second term for Malpass when his term ends in 2024.

A coalition of civil society groups on Wednesday called for the Bank to fire Malpass.

Activists and former climate advocates worry the World Bank is falling short on climate action. Last year, over 70 non-governmental organizations jointly called for Malpass to be replaced, citing a lack of action.

World Bank’s Malpass, under fire on climate views, says no shareholders asked him to resign

https://hollywoodwealthhub.com/2022/09/23/white-house-condemns-world-bank-chief-malpasss-climate-comments/

Moderna asks FDA to authorize omicron booster shots for kids as young as 6

 Moderna on Friday said it has asked the Food and Drug Administration (FDA) to authorize its COVID-19 bivalent booster shot for adolescents and children as young as 6 years old.

The application for children ages 6 months to under 6 years is expected to be completed later this year, the company said.

The announcement was made on Twitter, with no additional details.

Moderna’s booster shot is currently authorized for adults, while the bivalent booster from Pfizer/BioNTech is authorized for adolescents as young as 12. They have not yet asked FDA to authorize the shot for younger kids.

In a document published earlier this week, the Centers for Disease Control and Prevention said it anticipates a recommendation for bivalent COVID-19 boosters for young children in early- to mid-October, pending FDA authorization.

The agency said it expects that if bivalent boosters are authorized for individuals aged 5 years and older as a booster, the original mRNA COVID-19 vaccines may no longer be authorized as booster doses, only as an initial vaccine series. 

Bivalent boosters contain mRNA targeting the original strain of SARS-CoV-2 as well as the BA.4/BA.5 subvariants of the Omicron strain, which are currently the most prevalent versions of the virus circulating.

The Biden administration has procured over 170 million doses of bivalent COVID-19 vaccine for distribution and administration, enough to “ensure a robust and complete national booster vaccination campaign through the fall and early winter,” CDC said. 

Doses of bivalent Moderna vaccine for children aged 6 to 17 are expected to come from the same vials currently in the field that are being used to vaccinate adults.

The Moderna bivalent vaccine for adolescents and teenagers aged 12 to 17 years is expected to be the same volume and dosage as is currently authorized for adults, while the vaccine for kids ages 6 to 11 is expected to be half the volume and dosage that is currently authorized for adults.

https://thehill.com/policy/healthcare/3658319-moderna-asks-fda-to-authorize-omicron-booster-shots-for-kids-as-young-as-6/

Cancer-killing virus tested as cutting-edge therapy

 Researchers have genetically modified a herpes virus to direct an antibody to “destroy tumors and to generate an anti-tumor immune response,” described in the clinical trial website.  

The herpes virus is one of the types of viruses that cause cold sores. 

The cold-virus-therapy, called RP2, is in phase 1 clinical trials, with 36 participants enrolled, and the preliminary results are promising. 

According to BBC News, the findings were presented at a medical conference in Paris. Overall, the data showed that tumors shrank in three out of nine patients given RP2, and seven out of 30 who had a combined treatment also seemed to benefit. Side effects like tiredness were generally mild. One participant explained to the BBC that they got injections every two weeks for five weeks and subsequently were cancer free for the following two years. 

“It is rare to see such good response rates in early stage clinical trials, as their primary aim is to test treatment safety, and they involve patients with very advanced cancers for whom current treatments have stopped working,” says lead researcher Kevin Harington at The Royal Marsden NHS Foundation Trust to the BBC. 

Similar technology from this team was approved in the United Kingdom to treat skin cancer. In order to get approval for RP2 to treat solid tumors, there will need to be more clinical trials with a larger group of people. 

https://thehill.com/changing-america/well-being/prevention-cures/3658458-cancer-killing-virus-tested-as-cutting-edge-therapy/

If this is what the end of the pandemic looks like, that’s bad

 Even before President Biden’s highly publicized recent assertion that the COVID-19 pandemic is over, there was plenty of discussion on this topic in public health circles and beyond. Dropping the “p” word from our COVID-19 discourse would suggest to many that our current state of play is something we should accept for the foreseeable future.

If that’s the case, we should brace ourselves for a new normal in the U.S. with persistent labor shortages, buckling health care and a daily death toll that would have seemed unthinkable in February 2020.  

The definition of “pandemic” is not precise or widely agreed upon, so this debate was never going to be straightforward. From a public health perspective, this still looks like a pandemic — transmission is global, high and somewhat unpredictable. But in the U.S. (and most of the world besides China), disruptive COVID-19 policies are a thing of the past and individual risk has gone down considerably — thanks to some combination of vaccination, previous infection, treatments and weaker variants. That’s enough for many people to declare the pandemic over, choosing a broader definition that is as much psychological as it is epidemiological.

Biden’s comment last weekend was very much a reflection of this — he is well aware that there is now nothing but political downside for expressing COVID-19 caution. And with federal funding in limbo and politicians competing to see who can do less on COVID-19, Biden is now part of the broader movement to either implicitly or explicitly treat COVID-19 like it’s an “endemic” disease.

Like pandemic, agreement on the precise definition of “endemic” is hard to come by. But endemic usually refers to an epidemiological state whereby transmission follows some type of vaguely predictable pattern.

One thing endemic doesn’t mean is harmless. Seasonal flu, which is typically characterized as endemic, causes substantial amounts of illness, death and health care strain during a predictable time period (winter) and within predictable populations (elderly, immunocompromised and the very young). Endemic malaria in tropical parts of the world kills over half a million people a year, many of them children, usually during rainy seasons.

So, if COVID-19 is now settling into a predictable endemic pattern, what can we expect?

First off, whatever funding there is will mostly dry up as attention shifts elsewhere.

Based on 2022 outbreak dynamics, we are looking at about four to five waves of illness every year. Winter outbreaks will be worse than summer and coincide with a resurgent seasonal flu. But unlike flu, there will be no respite during the warmer months.

Economically, the service sector will struggle to regain its footing amidst large waves of illness, absenteeism and burnout from over-stretched employees.

Similar dynamics will affect our health care system, which is already running on fumes. Nurse and doctor shortages will continue due to illness and burnout, increasing the risks of bad outcomes for all illnesses, not just COVID-19. Health care costs will likely rise even faster as care for both COVID-19 and Long COVID creates additional upward price pressure on providers.   

We should expect testing levels to continue to go down as people get on with their lives, leaving us increasingly in the dark on true case counts.

But deaths from COVID-19 are somewhat easier to track. And while death certificates are not always 100 percent accurate, they are less susceptible to the “with COVID not from” challenge that has characterized the COVID-19 hospitalization numbers in 2022 (claims that this was widespread in 2020 and most of 2021, however, are inaccurate). If 2022 is any indicator, we could see around 125,000 deaths per year, or about four times worse than a typical flu season. Not exactly the herd immunity sweet spot that armchair epidemiologists were latching on to in 2020 and far from a post-pandemic new normal that anyone would have characterized as desirable in 2020.

But if all of this sounds overly certain, it is. The reality is that identifying an endemic state for COVID-19 can only be done in the rear-view mirror after a few years of roughly similar outbreak dynamics.

And if COVID-19 has taught us anything, it’s that long-term predictions that are delivered with extreme certainty are usually wrong.

So, it remains very difficult to characterize this moment in time. Perhaps the best-case scenario is that COVID-19 is, in fact, not endemic right now. Perhaps new virological twists and turns introduce a less virulent variant into the mix and COVID-19 finally settles into similar territory as other common cold coronaviruses. Perhaps intra-nasal vaccines will be better than our current vaccines at preventing infection, limiting the size of future waves.

Or perhaps the virus has other plans and severe illness and deaths far exceed the projections mentioned above.

While no one really knows where this will go, one way to increase the likelihood of these worst-case scenarios is to ignore them. Nobody is seriously advocating for lockdowns or suggesting we can eliminate all cases and deaths — but citizens and policymakers settling into a false sense of certainty and defeatism aboutCOVID-19 also isn’t the answer. Less disruptive investments like ventilation, wastewater surveillance and next generation vaccines and therapeutics could still go a long way to mitigate risk as we traverse this highly uncertain road to endemicity.  

Scott Rosenstein is a public health adviser to the Eurasia Group and a professor at Bard College’s Globalization and International Affairs program. 

https://thehill.com/opinion/healthcare/3658380-if-this-is-what-the-end-of-the-pandemic-looks-like-thats-bad/