COVID-19 throttles trial site expansion at Novocure

Citing COVID-19 disruptions, Novocure (NASDAQ:NVCR) announces that the expansion of clinical trial sites has been “materially delayed,” adding that the timing of enrollment and completion of studies will most likely be extended by multiple quarters.

Management will update investors on its pipeline during its Q1 earnings call.

https://seekingalpha.com/news/3558131-covidminus-19-throttles-trial-site-expansion-novocure

3M will have ‘big price to pay’ over masks – Trump

Pres. Trump slams 3M (NYSE:MMM) in a tweet last night, saying his administration “hit 3M hard today after seeing what they were doing with their masks… will have a big price to pay,” without further elaboration.

Trump apparently was referring to a Fox News report featuring the head of Florida’s Division of Emergency Management accusing 3M of shipping N95 masks to foreign countries who outbid U.S. buyers, while U.S. hospitals and state officials scramble to secure protection for healthcare workers fighting the coronavirus.

Trump earlier announced he was invoking the Defense Production Act to get the company to produce face masks.

https://seekingalpha.com/news/3558077-3m-will-big-price-to-pay-over-masks-trump

Shipping begins for rapid antibody test – COVID-19 updates

Aytu BioScience (NASDAQ:AYTU) has begun shipping its rapid antibody blood test for COVID-19. Shares up 8% premarket.

Stryker (NYSE:SYK) has developed a low-cost limited-release emergency response bed for healthcare providers during the pandemic. It anticipates being able to produce 10K beds per week.

Novartis (NYSE:NVS) and the Novartis US Foundation have established a US COVID-19 Community Response Fund that will provide $5M in cash and in-kind donations for immediate response and recovery efforts.

ResTORbio (NASDAQ:TORC) has postponed enrollment in the fifth cohort in its ongoing New Zealand-based Phase 1b/2a clinical trial of RTB101 in Parkinson’s due to level 4 alert there.

Capricor Therapeutics (NASDAQ:CAPR) will provide its CAP-1002 cell therapy under compassionate use for patients with advanced COVID-19. Shares up 34% premarket.

I-Mab (NASDAQ:IMAB) announced FDA sign-off on its IND for a clinical trial evaluating TJM2 for the treatment of cytokine release syndrome in severely ill COVID-19 patients. Shares up 9% premarket.

https://seekingalpha.com/news/3558148-shipping-begins-for-rapid-antibody-test-covidminus-19-updates

First peer-reviewed coronavirus vaccine shows promise in mice

A new potential vaccine against the coronavirus sweeping the world has showed promise in mice, researchers at the University of Pittsburgh School of Medicine said Thursday.
In a peer-reviewed study published in the medical journal EBioMedicine, the researchers said their new development comes from earlier vaccines they had created to fight the two other deadly coronavirus strains already known: SARS, which broke out in China in 2003, and MERS, which hit Middle Eastern countries and South Korea in 2014.
“We have been designing coronavirus vaccines since 2003,” Andrea Gambotto, an associate professor of surgery at the Pitt School of Medicine and one of the study’s two lead authors, told The Hill in an interview.

The researchers repurposed those earlier vaccines to target a specific protein that protrudes from the new version.
“For us, it was easy to switch gears from one target to the other,” Gambotto said. “We had all the pieces together.”
The study showed that when tested in mice, the vaccine produced antibodies that were specific to the current coronavirus, and in quantities that are likely sufficient to neutralize the virus.
Unlike many vaccines, the Pitt-developed version would be delivered by a fingertip-sized patch that scratches the surface of a recipient’s skin. The scientists said the immune system reacts more strongly to irritations on the skin, in hopes of triggering it to recognize the coronavirus more quickly.
The delivery method is similar to a vaccine used to eradicate smallpox, said Louis Falo, chair of the dermatology department at the Pitt School of Medicine and the University of Pittsburgh Medical Center. Falo said the team hoped to begin tests on human volunteers in short order.
“We’d like to begin testing in patients as soon as possible,” Falo said. “We would like to be in a phase one clinical trial in weeks. Not a week, maybe a month.”

The Pitt vaccine is at least the fourth potential candidate in the research pipeline so far. Johnson & Johnson said this week it had identified what it called a promising candidate, and that it would begin human trials by September. Last month, the first human trials of an experimental vaccine developed by Moderna began at the Kaiser Permanente Washington Health Research Institute in Seattle. The German research firm CureVac is developing its own vaccine.
Experts warned that no vaccine is proven to work until it has gone through the rigorous testing process — and in some historical cases, vaccines that have rushed to market have turned out to cause more harm than they solved.
It is not uncommon for multiple research teams to develop their own vaccines for the same disease. Every year, different groups try to come up with a vaccine for influenza that would cover multiple strains.
The Pitt researchers said they believe their methods make them a “front-runner,” in Gambotto’s words, in the current race to develop a vaccine against the coronavirus — but that they would be just as happy if someone else develops a viable vaccine faster.
“It’s a race because of the urgency. We have to race against the virus. If the competition makes it quicker, competition is welcome,” Gambotto said.
https://thehill.com/policy/healthcare/490866-first-peer-reviewed-coronavirus-vaccine-shows-promise-in-mice

Jobs growth comes to screeching halt in March

March nonfarm payrolls: -701K vs. -150K consensus and +275K previous (revised from +273K).

Unemployment rate: 4.4% vs. 3.9% consensus and 3.5% prior.

https://seekingalpha.com/news/3558156-jobs-growth-comes-to-screeching-halt-in-march

March jobs report numbers might appear better than reality

Be prepared for a shock — the employment report for March that’s coming out on Friday may not be as bad as people are expecting.
But don’t misunderstand what I’m saying.
The job market right now is the worst it has been in over a decade. But quirks in how the monthly numbers are derived might make the statistics look a little less atrocious than they really are.
As a point of reference, the “experts” are expecting the US Labor Department to announce that 100,000 jobs were lost in March and that the unemployment rate jumped to 3.8 percent.
That compares with a whopping 273,000 new jobs that were created in February and a jobless rate for that month of just 3.5 percent.
Here are some reasons Friday’s initial figures for March might not be as bad as they could have been.
For one thing, the Labor Department’s surveys of companies and of individuals are done during the week that contains the 12th day of the month. And in March this wasn’t the week all the strictest coronavirus rules went into effect. It also wasn’t the week that the bulk of layoffs and furloughs began.
New claims for unemployment insurance suddenly exploded the week that began on March 16 and ended on the 21st. That’s when new jobless claims spiked to an all-time high of 3.3 million.
So the figures the Labor Department will release on Friday missed the worst of the job losses by a few days. ADP, which does a private survey of jobs, reported a loss of only 27,000 jobs at companies in March because of this timing glitch.
For those of you who like bad news, don’t worry. The figures will catch up to the devastation in the April figures released in early May. And downward revisions to the March numbers will trickle in over the next months and even years.

The true horror of what we are going through won’t be missed by history.
Speaking of history, you have to go back more than 10 years to find a period of employment that is this bad. The last time there was any decline in the monthly job figures was in September 2010 when the economy shed 65,000 jobs. In March 2009, the Labor Department reported an enormous decline of 800,000 jobs.
We could’ve beat that record this time. But because of the quirks I’m telling you about, the job-loss figures might be spread out more evenly over several months.
Here’s another thing: The standard when considering if a job exists isn’t very strict.
If someone is paid for any part of a month — even for one hour — that person is considered to have had a job and the job is considered to have existed.
In our current predicament, lots of people were paid in early March before their salaries were suddenly cut off.
Friday’s report won’t be good news. But it might not be as bad as it could have been.
https://nypost.com/2020/04/01/march-jobs-report-numbers-might-appear-better-than-reality/

Tracking COVID-19 hospital expenses important for federal funding

COVID-19 relief funding for hospitals will be coming through several government sources, so experts recommend that hospitals immediately begin tracking all their expenses and lost revenue.

Hospitals could be eligible for funds through the Federal Emergency Management Agency, several funding streams set up by Congress in the Coronavirus Aid, Relief, and Economic Security Act, state grants and HHS programs. Each of the funding sources can be used for different purposes, have different requirements and are likely to be audited later.

As hospital administrators are already dealing with a mounting crisis, Robert Reeves, a partner at Ernst & Young, recommends that hospitals identify a team to document expenses and lost revenue, identify funding sources, prioritize funding applications, and ensure documentation is in place so funds aren’t clawed back later for being improperly used.

“We really recommend clients after any disaster take a really holistic, enterprise-wide approach to financial recovery,” Reeves told providers on Monday.

Facilities that accurately track COVID-19 surge capacity expenses, staffing costs and policies that led to the cancellation or delay of elective procedures will be better able to back up their funding requests, RSM US healthcare partner Rick Kes said.

“If an organization has more sophistication in defining their costs and lost revenue, they will have a better answer if and when the government calls years from now. We are telling clients to take that part really seriously,” Kes said.

Timeliness is especially important for a $100 billion fund Congress set aside for providers in the CARES Act. Providers would be eligible for reimbursement for both costs and lost revenue due to COVID-19 and the funds will be doled out on a rolling basis. HHS hasn’t released full details about how the funds will be released, but Manatt Health managing director Brenda Pawlak said the application period will likely be “fast and furious” as acute-care hospitals, critical access hospitals, community health centers, long-term care facilities, inpatient rehabilitation facilities, ambulatory surgery centers, behavioral health providers and others could be eligible for assistance.

“Everybody will need to apply quickly, and they need to be prepared and willing to do that,” Pawlak said.

Hospitals are already jockeying to ensure they get most of the funds, and quickly. The American Hospital Association told HHS Tuesday that they want every hospital across the country to directly and immediately get $25,000 per hospital bed, with additional payments for hospitals in COVID-19 hotspots. The baseline funding request alone would cost $23 billion, the group estimated.

The Federation of American Hospitals on Wednesday asked HHS to ensure a “substantial majority” of the funds are allocated to hospitals.

Background materials on the CARES Act released by Senate Democrats said that if providers received reimbursement for the same expenses from two sources, the CARES Act provider grant funds would have to be repaid.

Providers may also be eligible for corporate loans with strings attached including restrictions on executive pay and small-business loans if they have fewer than 500 employees. These loans stem from the CARES Act.

FEMA grant processes will vary state-by-state as not all states have declared emergencies, and funds cannot be used for lost revenue. Only not-for-profit institutions would be eligible.

https://www.modernhealthcare.com/finance/tracking-covid-19-hospital-expenses-important-federal-funding