FDA Could Approve Remdesivir For Emergency Use As Soon As Tomorrow

FDA Could Approve Remdesivir For Emergency Use As Soon As Tomorrow

When Dr. Fauci said the FDA and Gilead would move to “quickly” get remdesivir into the hands of COVID-19 patients, we didn’t think they’d move this quickly.

In a sudden break from a federal virus response that has at times been criticized for unnecessary delays – delays drive by petty political squabbles and other hangups, from the ‘PPP’ to the CDC’s badly botched testing rollout – the FDA could move to grant emergency approval to remdesivir, an antiviral initially developed to treat ebola, but was never approved for that, or any other, medical purpose – as quickly as Wednesday aka tomorrow.

That’s according to the NYT, which spoke to a ‘senior official’ about the matter. It has all the hallmarks of an authorized ‘leak’, probably OK’d directly by Dr. Fauci himself (native New Yorker that he is).

To be sure, there remains some dispute about the drug’s efficacy, as we pointed out earlier. Despite all that, Gilead announced some positive data from a NIAD study earlier today – that the drug had met its ‘target’ of shortening recovery time – by Gilead is apparently enough to satisfy Dr. Fauci, who said remdesivir reminded him of the early data on studies of AZT during the AIDS outbreak. He explained that some of the initial studies were inconclusive, even as positive results seemed to be readily apparent.

Whether the drug can reduce the mortality rate in a more “statistically significant” way remains unclear, as does whether the drug is strictly safe for all human patients.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


Tyler Durden

Wed, 04/29/2020 – 14:32

via ZeroHedge News https://ift.tt/2VOYogP Tyler Durden

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