This thing is getting approved. The drugs works and the vote was 17-1 for. The committee members who voted no suggested that the drugs needs to be shown effective in a emergency room setting preapproval which was a 9-8-1 vote. This is impossible to track preapproval . People would have to request the drug first before there is an emergency room setting otherwise it would have been in the original data report. The FDA will track all emergency room actions postapproval. Just my thoughts.
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