Advisory Committee (AdComm)
What is Advisory Committee (AdComm)?
An FDA advisory committee of external experts that reviews data and votes on recommendations for drug approvals.
Why does Advisory Committee (AdComm) matter?
FDA Advisory Committees (AdComms) are panels of outside experts — physicians, statisticians, patient advocates — who review clinical data and vote on whether FDA should approve a drug.
AdComm votes are not binding, but FDA follows them roughly 75% of the time. A negative AdComm vote can crater a biotech stock; a positive one can send it soaring.
AdComm meetings are public, streamed live, and the briefing documents are published days in advance. This makes AdComm week one of the most closely watched events in biotech investing.
Companies present their data, FDA presents its review, the committee debates, and then votes. The drama is real — careers and billions of dollars hang on a show of hands.
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