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Hog Killer

04/23/21 12:12 PM

#161134 RE: Bill_ENG #161112

Bill E, Misiu, Excellent post and well said! Lets jump on this band wagon and demand a public review INCLUDING LL!

Mike Abrams appears to be the contact man. Can one of our DR's reach out to him? Here is the excerpt from the letter:

“The FDA’s previous failure to convene its own public advisory committee to consider whether to approve remdesivir was inexcusable,” said Michael Abrams, M.P.H., Ph.D., a health researcher in Public Citizen’s Health Research Group, and lead author of the letter. “This failure is particularly troubling given that the agency was aware of evidence from a major clinical trial that raised substantial doubts about whether the drug provides clinically meaningful benefit.”

The letter requests that FDA Acting Commissioner Janet Woodcock convene a public meeting of the FDA’s Antimicrobial Drugs Advisory Committee to review the agency’s October 2020 decision to fully approve remdesivir, which was already available to patients in the U.S. under an Emergency Use Authorization (EUA). Public Citizen contends that based on the available evidence regarding the effectiveness of remdesivir, this full approval decision was not justifiable.