Not quite in answer to your question but the research done by Ma, Singh, Smith and Townsend considered the strength of the advisory committee endorsement by creating three equal categories (by looking at the percentage of votes cast): (i) less than or equal to 33% endorsement for approval; (ii) between 33% and 67% endorsement for approval; and (iii) greater than or equal to 67% endorsement. The chart shows that the duration of the FDA approval date varies inversely with the strength of the endorsement.
We know that we don't have to wait 140 days though!!
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- Will the FDA refuse approval in the face of the favourable ODAC 9 versus 1 vote?
Will the FDA refuse approval in the face of the favourable ODAC 9 versus 1 vote?, page-9
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