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Trump’s use of Regeneron treatment creates ‘tough situation’: CEO

President Donald Trump’s use of Regeneron’s experimental coronavirus treatment creates “a very tough situation” for the drugmaker since it hasn’t been cleared for broader use, CEO Dr. Leonard Schleifer told CNBC on Monday.

The president, who announced Friday that he and first lady Melania Trump tested positive for the coronavirus, was given an 8 gram dose of Regeneron’s monoclonal antibody treatment, his doctors said.

The company said it provided the drug to the president in response to a “compassionate use” request from Trump’s doctors, which allows for expanded access to experimental drugs for “immediately life-threatening” illnesses, according to the Food and Drug Administration. It allows patients to access an investigational drug outside of clinical trials in lieu of adequate other treatments.

That means that while the president’s doctors were confident enough of the drug’s benefit to administer it to Trump, the treatment remains unavailable to most Americans.

“We have tried to take a principled approach until there is a broader authorization,” Schleifer told CNBC’s Meg Tirrell on “Squawk Box.” “Asking somebody like the president to go into a clinical trial just wasn’t practical.”

Until the FDA takes a look at all the available data on the benefits and risk of the drug for Covid-19 patients, patients who want to receive the treatment should enroll in a clinical trial, Schleifer said. He added that patients in clinical trials are closely monitored so that researchers can understand how the drug affects the disease, but at least a third of patients will receive a placebo.

“Giving it to [Trump] or to others who might not be able or don’t qualify for clinical trials is the right use of compassionate use. That’s for small numbers of people, for these exceptions,” he said. “We want everybody to be potentially able to benefit. We understand we don’t make that decision. This is a decision the FDA has to make.”

Schleifer added that he thinks the treatment meets “a lot of” the FDA’s standards for an emergency authorization. But he said the company needs to continue to collect data in controlled clinical trials to better understand the treatment. But as trials continue, the virus continues to infect more than 40,000 people every day across the U.S.

“This is all very complicated because it’s real lives at stake” he said. “If it’s my loved one or your loved one, … yes, we want to give this if we can help them. Of course, we want to get definitive evidence, so it’s a tough act to balance.”

Shares of the company were up more than 5% in early trading Monday.

Some analysts have speculated that the use of Regeneron’s antibody cocktail to treat the president is a tacit endorsement of the drug and could signal a swift approval by the FDA. Schleifer, however, tried to assure the public in the CNBC interview that the FDA has its own standards for authorization and the White House does not play a role. 

The class of drug has long been used to

Trump Situation Proves Anyone Can Get Coronavirus

HOBOKEN, NJ — Hoboken Mayor Ravi Bhalla said Saturday that there’s a lesson in the recent news about President Donald Trump and top-level White House officials contracting coronavirus.

“This development should serve as a real wake-up call to all of us, that covid-19 is still a formidable opponent requiring vigilance in all aspects of our lives,” Bhalla wrote in a virus update for residents Saturday night. “Even the most powerful and well protected people in the country can’t escape covid-19 if it isn’t taken seriously.”

Trump was brought to Walter Reed Hospital on Friday. Former Gov. Chris Christie and other officials who have been to recent White House events have also tested positive.

Bhalla said that in the last three days, Hoboken has seen 18 new cases of the virus, many within the same family.

“There have been no reported clusters or superspreader events reported,” Bhalla noted.

But, he said, people shouldn’t let their guard down just because they’re tired of precautions.

Hoboken was one of the first cities in the country to begin shutting facilities in March. Since then, the city of 53,000 people — across the river from Manhattan — has seen 31 fatalities from the virus, the last in May.

A total of 805 Hoboken residents have tested positive for covid-19, including the 18 new cases. Last Saturday, the number of cases was 772.

“Unfortunately, we are seeing a similar pattern of increasing cases in Hoboken as is occurring across New Jersey,” Bhalla wrote. “Today, 957 additional positive cases were reported across the state, the most cases since May 29, while the rate of transmission of 1.24 is the highest it has been in almost two months (anything above 1 indicates the virus is spreading).”

More than 14,000 people have died of the virus in New Jersey, including four more deaths announced Saturday. More than 209,000 people have died nationally, with cases increasing in several states (see which states have flattened the curve here).

‘Resort to the mindset we had in March and April’

Bhalla said, “Unfortunately, too many of us here in Hoboken and across the state are beginning to let our guard down, as if covid-19 will just go away with the passage of time … a continued rise in cases could have major impacts to our schools, jobs, and overall way of life if the state must revert to stay-at-home measures.”

He said, “Given the increase in cases, I’m asking all residents to resort to the mindset we had in March and April — to assume that anyone you come into contact with could have COVID-19.”

(In late March, Hoboken officials said the local hospital was about to run out of ventilators for sick patients, and the mayor had advised residents to shelter at home.)

Bhalla explained Saturday, “This means limiting socializing and congregating with members outside your family or household, maintaining social distancing at all practical times, prioritizing outdoor activities, avoiding large indoor gatherings, and wearing a face mask. I know