Trump weighing potential emergency declaration for coronavirus

President Trump is weighing whether to declare a national emergency over the coronavirus, which would free up additional resources to combat the rapidly spreading disease.
The president indicated to reporters that using an emergency declaration under the Stafford Act was under consideration, but would not say definitively whether he would sign it on Thursday.
“We have things that I can do. We have very strong emergency powers under the Stafford Act,” he said during an Oval Office meeting with the Irish prime minister. “I have it memorized practically as to the powers in that act, and if I need to do something I’ll do it. I have the right to do a lot of things that people don’t even know about.”

Asked if he planned to declare a national emergency on Thursday, Trump deflected.
“I don’t want to say that, but you know, at some point,” he said.
Trump can declare a national emergency or a major disaster declaration under the Stafford Act, which would enable the Federal Emergency Management Agency (FEMA) to mobilize additional resources and funding to fight the coronavirus.
There were roughly 1,300 people with confirmed cases of the coronavirus in the U.S. as of Thursday morning, and 37 people had died from the virus, according to The New York Times.
Trump’s remarks Thursday came a day after he announced that the U.S. would restrict travel from Europe for the next 30 days in an effort to stem the spread of the virus.
The president also said he would use executive orders to offer financial relief to individuals and small businesses impacted by the fallout over the disease.

Multiple advisers to the president have indicated he is seriously considering signing an emergency declaration on Thursday in what would be the latest significant step to try to combat the fallout from the coronavirus.
“If ever there was an emergency, it’s now. We’re a week away from being Italy,” one adviser told The Hill, invoking the Italian government’s decision to largely shut down the country to stop the virus from spreading.
CNN reported that top economic adviser Larry Kudlow informed congressional Republicans that Trump could sign the declaration as early as Thursday afternoon.
Trump may be hesitant to declare a national emergency after spending the past several weeks downplaying the severity of the coronavirus. He predicted in late February that the number of cases could quickly drop to near zero, and told a conservative conference that the administration deserved an “A+++” for its work containing the disease.
But as new cases are reported each day, Trump has been forced to adopt more serious measures, such as those laid out in his Wednesday night address.
Top health officials in the Trump administration said the decision to restrict travel from Europe would be beneficial, but have warned in recent days that the worst of the virus was yet to come. Still, Trump on Thursday projected optimism.
“We’re in great shape compared to other places,” he said. “We want to keep it that way.”
https://thehill.com/homenews/administration/487243-trump-weighing-potential-emergency-declaration-for-coronavirus

Organogenesis Holdings (ORGO) Receives a Buy from Oppenheimer

In a March 10 report, Steven Lichtman from Oppenheimer maintained a Buy rating on Organogenesis Holdings (ORGO), with a price target of $9.00. The company’s shares closed last Monday at $3.09, close to its 52-week low of $3.00.
In a report issued on March 6, Credit Suisse also reiterated a Buy rating on the stock with a $8.00 price target.
The company has a one-year high of $14.30 and a one-year low of $3.00. Currently, Organogenesis Holdings has an average volume of 74.83K.
Based on the recent corporate insider activity of 16 insiders, corporate insider sentiment is positive on the stock. Over the past quarter there has been an increase of insiders buying their shares of ORGO in relation to earlier this year.
Organogenesis Holdings, Inc. is a regenerative medical company. It focuses on the development, manufacture and commercialization of product solutions for the advanced wound care, surgical, and sports medicine markets. The company was founded in 1985 and is headquartered in Canton, MA.

Organogenesis Holdings (ORGO) Receives a Buy from Oppenheimer

Hundreds of Virus Patients Allowed to Try Gilead’s Ebola Drug

• Repurposed Ebola antiviral furthest along in drug development for Covid-19
• Many in Washington state among those treated, CDC chief says

Hundreds of coronavirus patients have been treated with Gilead’s experimental Ebola treatment under an FDA program to allow access to unapproved drugs.
Gilead Sciences, Inc. expects to know by April whether a clinical trial in China testing the antiviral drug remdesivir can effectively treat patients infected with the virus that causes Covid-19. But company spokesperson Ryan McKeel said Tuesday it’s already “provided remdesivir on a compassionate use basis to treat several hundred patients with confirmed, severe COVID-19 infection in the United States, Europe and Japan.”
Expanded access, also known as compassionate use, allows patients with life-threatening conditions who have run out of options to try experimental therapies outside of a clinical trial. The Food and Drug Administration must approve all expanded access requests, which it does more than 99% of the time, but the company is never required to provide the experimental drug.
A number of people in Washington state have been treated with remdesivir through the compassionate use program, CDC Director Robert Redfield told a House appropriations panel during a hearing on Tuesday. Twenty-three of the 28 deaths in the U.S. that are linked to Covid-19 outbreak have occurred in Washington state.
“For people that are very sick, and we have a number that are very sick, there is an experimental drug called remdesivir that’s available right now in compassionate use. This country has used it,” Redfield said in response to a question form Rep. Bonnie Watson Coleman (D-N.J.).
The Department of Health and Human Services announced last week it provided remdesivir to severely ill patients in Japan as part of a collaboration with the U.S. Public Health Service Commissioned Corps; the U.S. Embassy in Japan; the Japanese Ministry of Health, Labour and Welfare; and Gilead Sciences Inc.
Remdesivir has shown promise in animal studies as a possible treatment for Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), which are caused by other coronaviruses.
Other companies such as AbbVie Inc. are pursuing cornoavirus therapies. But Gilead’s remdesivir is furthest along in the drug development pipeline, Anthony S. Fauci told, director of the National Institute of Allergy and Infectious Diseases, told a Senate panel March 3.
https://news.bloomberglaw.com/pharma-and-life-sciences/hundreds-of-corona-patients-allowed-to-try-gileads-ebola-drug

Estimating the cost of coronavirus development

Money will of course be no object when it comes to funding development of treatments for Covid-19, but how much exactly are we talking?

A lot of time and resources are being thrown at developing treatments for Covid-19, with governments around the world pledging to spend whatever it takes to find a treatment. Much of the initial expense will fall on biopharma companies, however.
To estimate how much these investigations might cost, Vantage has extracted estimates from EvaluatePharma Vision and looked at historic precedent, for the development of vaccines and antivirals in previous pandemics.
Phase III trials of Gilead’s remdesivir are likely to be the most expensive ventures right now; the US biotech has indicated that initial data should emerge before the end of March. This readout represents the world’s nearest-term chance of finding a treatment for the sometimes deadly respiratory symptoms caused by this particular coronavirus.
According to EvaluatePharma Vision’s R&D Costs module, these trials will probably cost Gilead around $150m to run. Estimates of the phase III trials being run in China are also included – the much lower figures reflect the fact that it is substantially cheaper to run studies in this region. A description of how these costs are calculated is below.
Gilead can afford this, of course, and should remdesivir prove effective the commercial return is likely to be huge, notwithstanding the company claiming their efforts are not rooted in the commercial. Roche has booked cumulative sales of $15.9bn of Tamiflu since it was launched in 1999; annual sales peaked at just over $1bn in 2014. These figures exclude sales booked by the other companies that make it
A previous Vantage analysis, looking at historic sales of flu antivirals, shows how much these drugs brought in for their developers (Previous pandemic antiviral demand spike sees Biocryst jump aboard, March 5, 2020).

Coronavirus costs – antiviral development
Details	Estimated cost of trial ($m)*	NCT ID
US sponsored studies
Moderate Covid-19 disease, remdesivir vs SoC (n=600)	92	NCT04292730
Severe Covid-19 disease, two remdesivir regimens (n=453)	61	NCT04292899
NIAID-sponsored adaptive Covid-19 treatment trial (n=394)	88	NCT04280705
Chinese sponsored studies
Severe Covid-19 respiratory disease (n=453)	31	NCT04257656
Mild-moderate Covid-19 respiratory disease (n=308)	21	NCT04252664
Estimated total clinical costs of developing Tamiflu	300	–
Estimated total clinical costs of developing Relenza	393	–
SoC = standard of care. Source: EvaluatePharma Vision.

*EvaluatePharma Vision’s R&D cost model estimates the cost of individual clinical programmes using real-world data. Company disclosed product-level spend and clinical trial patient numbers are combined to create cost per patient benchmarks by technology and therapy type. Utilising a matching algorithm, these benchmarks are applied to all commercially relevant clinical trials to estimate their cost, which can then be aggregated by product to estimate the cost of development of all products. 
https://www.evaluate.com/vantage/articles/news/corporate-strategy/estimating-cost-coronavirus-development

New York’s coronavirus ‘containment zone’ may not do enough, residents say

People who live in the epicenter of New York’s coronavirus outbreak said they were not convinced the state’s order closing the area’s schools and large-gathering venues for two weeks would do enough to curb the spread of infection.

New York Governor Andrew Cuomo this week said he was heeding the advice of the state health commissioner by ordering a one-mile diametrical “containment zone” around an infection hotspot in New Rochelle, Westchester County, north of New York City.
The mandate closes three public schools, several private and parochial schools, houses of worship and other large gathering venues in that area for two weeks starting Thursday.
Still, some residents believe the zone is too narrow to limit the spread of the disease, which has infected at least 216 people in New York, including more than 120 in Westchester.
Joy Malone, a photographer in New Rochelle whose children attend two of the three public schools that have been closed, said shutting just three of the city’s 10 public schools made no sense.
“There are children in all three who have siblings in the other seven,” Malone said. “It’s a huge mistake, especially with the severity of what is happening.”
More than 1,300 people in the United States have contracted the highly contagious respiratory illness caused by the virus, and at least 38 have died, most of them in Washington state, according to a tally by Johns Hopkins University.
The cluster of some 121 cases in Westchester County emerged after an attorney who lives in New Rochelle and works in Manhattan became the second person in New York to be diagnosed with the virus last week.
Several cases in the city have been traced to the Young Israel Synagogue of New Rochelle, where the attorney attended services last month. The synagogue, which public health officials closed last week, is at the center of the containment zone.
Health officials hoped the containment zone would prevent large gatherings of people and slow the spread of the illness, but the measure would not stop people’s movement into and out of the area, New Rochelle Mayor Noam Bramson said.

In a phone interview with Reuters, Bramson said state and federal health officials decided the parameters of the zone with little input from city officials.
“All of those factors were considered by the state, and they judged the containment zone to be a sensible way of proceeding,” Bramson said.
“For a locality like New Rochelle to independently freelance without the expertise to back up our local judgments I think would be a very serious mistake,” he said.
Governor Cuomo said he would deploy the National Guard during the period of containment to clean schools and other buildings and deliver food to those in need, including thousands of children who rely on school meals.
Not every parent was displeased by the state’s order.
Denise Logan, who lives in the containment zone, said her children have so far enjoyed the novelty of completing their school work remotely.

“I thought that closing the schools was going to be inevitable,” she said. “It seems like a very good idea to me.”
Kelly Ann DeCola, a New Rochelle resident whose children’s schools were not affected, did not want schools to close because she could not afford to skip work to care for her children at home.
Regardless, DeCola said the decision to close only a few schools, and not all, was “astronomically illogical” because children from across the city congregate for various activities and may even spend more time together now without the confines of a school day, heightening the risk of the virus spreading.
“Children from all over the city join together for basketball, soccer, karate, after-school programs, dancing school,” DeCola said in a Facebook message. “Now we’re going to have teenagers congregating in areas that they would have not been before.”
https://www.reuters.com/article/us-health-coronavirus-new-york-westchest/new-yorks-coronavirus-containment-zone-may-not-do-enough-residents-say-idUSKBN20Z2JK

First online U.S. census kicks off amid coronavirus fears

U.S. residents will begin receiving census forms in the mail as early as Thursday as the federal government kicks off its once-a-decade count of the population, a gargantuan effort crucial to guiding U.S. political and economic policy but which experts fear will be complicated by the spread of coronavirus.

The 2020 survey is expected to cost taxpayers some $15 billion and is meant to be the first taken largely online. Most residents receiving forms will be asked to submit responses at my2020census.gov, instead of by mail. But as in the past, census door-knockers will be dispatched to households that do not answer the letters.
The virus might discourage people from answering the door, said Jeffrey Wice, a census expert and Democratic redistricting adviser. Headlines about coronavirus and the resulting economic strain might also make it harder to spread awareness about the count.
“The Census Bureau will have difficulty grabbing people’s attention,” said Terri Ann Lowenthal, a consultant and former congressional staffer overseeing census matters. “I think the environment for promoting census participation becomes much more difficult.”
The count’s accuracy is critical, as the survey determines how the U.S. Congress and state legislatures draw voting districts during the next round of redistricting and guides the federal government in allocating $1.5 trillion a year in aid.
In a statement Wednesday on the impact of the virus, the Census Bureau encouraged residents to respond online as soon as possible, to minimize the need for in-person visits.
For now, the door-knocking campaign is still planned, but the bureau said it is following guidance from public health officials. “If we need to delay or discontinue nonresponse follow-up visits in a particular community, we will adapt our operation to ensure we get a complete and accurate count,” the statement said.
The census has faced other challenges. The nonpartisan Government Accountability Office last month reported the bureau was behind in its recruiting of census workers, while Reuters reported last year that the bureau’s new IT infrastructure was vulnerable to glitches and hacks.
The bureau did not immediately respond to requests for comment. It has said that it had enough workers to carry out the census, and that its IT system had worked as designed during tests.
Efforts to spread misinformation about the count also threaten to discourage participation by some groups, according to data experts and civil rights advocates who monitor census discussions online.
Last week, Facebook Inc took down ads by U.S. President Donald Trump’s re-election campaign that asked users to fill out a survey that it called the “Official 2020 Congressional District Census.” Facebook said the ad violated its policy against spreading misinformation about the actual U.S. Census.
The Trump administration’s effort to add a question asking census respondents whether they are U.S. citizens also incited fear in Hispanic and immigrant communities that the information could be used against them.

The citizenship question was invalidated by the U.S. Supreme Court last year, but more than a quarter of non-whites under 65 throughout the United States still say they may not respond to the census, according to an Urban Institute study released in February. The Census Bureau is partnering with local institutions like schools, churches and radio stations to promote the tally.
“We have improved the partnership program” since the last census in 2010, said Sergio Martinez, who oversees the program for Utah and New Mexico. “The success of the response rate relies on local engagement.”
https://www.reuters.com/article/us-usa-census-kickoff/first-online-u-s-census-kicks-off-amid-coronavirus-fears-idUSKBN20Z1JH

Greece to turn bootleg booze into coronavirus antiseptic

Greek authorities plan to turn tonnes of ethanol confiscated from bootleg booze-makers into sanitizer to combat the coronavirus epidemic.
Up to 155 tonnes of seized alcohol is languishing in customs warehouses across the country. Authorities say they are trying to find manufacturers willing to convert it into antiseptics.
“We moved swiftly to make it available to the Ministry of Health to be used for the general population,” said George Pitsilis, head of the state Independent Authority for Public Revenue.

Greek customs authorities confiscate thousands of bottles of counterfeit alcohol every year, known locally as ‘bombes’.
Vats with misleading labels such as “sugar syrup” or “distilled water” pack a punch. Lab testing showed it had alcoholic volume between 93.5% and 96.5%.
“Fortunately they came at just the right time. Now there is a shortage of pure spirit on the market because of the general shortage in antiseptic gels,” a customs agent told Reuters.
https://www.reuters.com/article/us-health-coronavirus-greece-alcohol/sanitizer-galore-greece-to-turn-bootleg-booze-into-coronavirus-antiseptic-idUSKBN20Z2GE