Gilead Sciences Inc (GILD)

[north40000]

It appears, two212 and others, we will soon see whether statements that Remdesiver is worthless in the context below are true or false:

FDA Authorizes Emergency Use of Gilead Drug Remdesivir for Covid-19 Patients -- 2nd Update Dow Jones News - 5/1/2020 7:05:00 PM
FDA Authorizes Emergency Use of Gilead Drug Remdesivir for Covid-19 Patients -- Update Dow Jones News - 5/1/2020 5:01:00 PM
FDA Authorizes Emergency Use of Gilead Drug for Covid-19 Patients Dow Jones News - 5/1/2020 4:39:00 PM

http://ih.advfn.com/stock-market/NASDAQ/gilead-sciences-GILD/stock-news/82363836/fda-authorizes-emergency-use-of-gilead-drug-remdes:

".....Anthony S. Fauci, the Institute's director and the government's leading infectious-disease doctor, said in an interview that the reduction in time to recovery was "highly statistically significant." A data safety and monitoring board analyzed the trial data on Monday and shared its findings with the investigators in the study.

Preliminary analysis of 468 recovered patients showed that patients on remdesivir took a median time of 11 days to recover from their disease, whereas those on placebo took 15 days, a difference of 31%. Recovery, defined as a patient being well enough to leave the hospital or to return to normal activity, is a standard measure in flu studies, the NIAID said in its discussion of the research.

The results so far also pointed in a positive direction regarding the death rate. Among the roughly 1,060 patients enrolled in the study, there was an 8.0% death rate among the remdesivir patients, versus 11.6% in the placebo group. The results weren't considered robust enough to be clinically significant, but data from the full study will continue to be analyzed. About 485 patients in the study are still being evaluated because they haven't recovered or died yet.

The study is headed by Andre Kalil, a professor of internal medicine at the University of Nebraska Medical Center. It encompasses 68 sites, of which 47 are in the U.S. and 21 in European and Asian countries. Full results, including rates of adverse events, haven't yet been published.

The research demonstrates, Dr. Kalil said in an interview, "not only that high-quality science can be done in the middle of a pandemic, but also that new therapies can be successfully discovered to treat patients severely affected by Covid-19."

Two antimalaria drug, chloroquine and hydroxychloroquine, already have emergency-use authorizations from the FDA, though the evidence supporting their expanded access was thinner. Both drugs are also undergoing clinical study.

Mr. Trump and members of his administration initially touted their use in Covid-19 treatment, but the FDA last month issued a warning against their use in nonhospital settings after they were linked to serious heart problems.

The NIAID study of remdesivir was a large randomized, controlled trial, the gold standard in drug research, lending it added prominence for U.S. health regulators. A separate recent study in China posted negative results for the drug, but that study's researchers urged more testing because their trial was stopped early due to problems recruiting subjects as the pandemic slowed there.

Joseph Walker contributed to this article.

Write to Michelle Hackman at [e-mail] and Thomas M. Burton at [e-mail]