#Reminisce pronounce trial

That decision by the agency has paved the way for accelerated approval pathways for other drugs. It did this on condition that the drugmaker, Burroughs Wellcome, would continue to study patients taking the drug, and report the results back to the FDA. The agency approved AZT without waiting for the long clinical trials required in other drug approvals.

The 1987 approval of azidothymidine - AZT - as the first AIDS medicine, was a game-changer for the FDA, he says. But 'the FDA can work with companies to provide a greased pathway.' 'You still have to have a drug and still have to show that the drug works,' Kaitin says. Kaitin, from the Tufts Center for the Study of Drug Development, says today's FDA is better equipped than ever to approve a drug quickly. The agency hopes to make a decision on remdesivir quickly. What Comes to Mind When Thinking of reminisce Synonym Discussion of Reminisce. The FDA says it has granted this sort of access to remdesivir to about 250 patients already.Īs for when the drug might be approved, FDA Commissioner Stephen Hahn has indicated that the agency is working closely with Gilead. The meaning of REMINISCE is to indulge in reminiscence. Compassionate use is when patients are allowed to get unapproved, experimental medicine outside of clinical trials. The FDA and Gilead are also granting access to the drug via 'compassionate use' programs. For example, it's possible, he says that the drug would only be beneficial for patients with mild or moderate symptoms, but be harmful to those with severe disease. He says human studies will not only tell us whether the drug works, but for whom it works. 'We got the drug on the weekend, and gave it to the first patient the very next day,' he tells NPR. 'We need answers sooner rather than later,' he says. Gandhi is pleased by how quickly his hospital was able to get going on its part of the clinical trial. At Massachusetts General Hospital in Boston, it began this week, says epidemiologist Rajesh Gandhi, who is leading the hospital's COVID-19 treatment taskforce.

#Reminisce pronounce trial

The National Institutes of Health's remdesivir clinical trial is taking place at sites around the United States. 'But such hope or expectation needs to be managed and balanced, and should let science speak for itself.' 'For patients or general public, it is understandable that hope is important,' says Ding, who also directs the Global Health Drug Discovery Institute. And without them, 'we cannot really conclude whether it works or not,' says Sheng Ding, dean of the school of pharmaceutical sciences at Tsinghua University. In another, they'll measure how many sick patients can leave the hospital within two weeks after starting treatment with remdesivir.īut it's too soon to see final study results. In one Gilead-sponsored trial, researchers are measuring how remdesivir affects sick patients' oxygen levels.