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Convalescent plasma players under pressure on FDA hold on emergency use nod

August 19, 2020

Processors of antibody-rich convalescent plasma, derived from COVID-19 patients who have recovered from the infection, are under the gun on a delay of the expected emergency use authorization from the FDA for the treatment of COVID-19.

NIAID clinical director Dr. H. Clifford Lane says the authorization is on hold to allow for the review of more data since clinical trials have not proven that the plasma helps patients fight SARS-CoV-2.

Recent data from the largest study to date, conducted by the Mayo Clinic, were not strong enough to support emergency use approval according to top health officials, including NIAID’s Dr. Anthony Fauci. Results involving more than 35K patients showed a lower mortality rate if the convalescent plasma was administered within three days of diagnosis compared to later administration but the study has no control group so it is not possible to confirm the treatment effect. Enrollment in the study has ballooned up to an “unmanageable” level says Dr. Lane.

A study in the Netherlands was stopped after investigators saw no difference in mortality, length of hospital stay or disease severity compared to placebo.

At least 10 randomized trials in the U.S. are struggling to recruit participants since they need to be sick and the pandemic is waning in many cities.

Selected tickers: Kamada (KMDA -8.8%), Grifols (GRFS +0.1%), XBiotech (XBIT -1.8%), Cerus (CERS -1.1%), ADMA Biologics (ADMA -8.3%)

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