Gilead Sciences (NASDAQ:GILD)
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2 Months : From Feb 2020 to Apr 2020
By Joseph Walker
Gilead Sciences Inc. said Wednesday it would start late-stage studies of its experimental treatment for the coronavirus in March, an acceleration of its push to evaluate what it hopes could be the first medicine specifically approved to treat the respiratory disease.
Gilead said it will conduct two studies with a total of 1,000 patients across mainly Asian countries, as well as other nations with high numbers of diagnosed patients.
Gilead is kicking off the studies following the U.S. Food and Drug Administration's acceptance of its investigational new-drug application, an early first step for studying unproven drugs in humans.
The studies, if successful, would help contribute to a larger dataset needed to win regulatory approval for the drug. It is too early to say if the two studies alone would be sufficient for regulators, said Diana Brainard, Gilead senior vice president for HIV and emerging viral infections.
"Things are moving so quickly, it's hard for us to gauge what the right approval package would look like in the U.S. or abroad," Dr. Brainard said in an interview. "We're in data-collection mode right now."
Gilead hopes to have at least an initial set of data results in May, Dr. Brainard said.
Gilead's drug, remdesivir, is already being studied in two sets of clinical trials. Chinese researchers earlier in February began enrolling patients with moderate disease and severe disease.
On Tuesday, the National Institutes of Health announced the start of the first U.S. study of remdesivir, which is being led by researchers at the University of Nebraska.
(END) Dow Jones Newswires
February 26, 2020 17:35 ET (22:35 GMT)
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