FDA Advisory Committee meetings often precede PDUFA approval decisions by 1–3 months. A favorable committee vote (especially a strong majority) substantially de-risks the approval. A negative vote doesn't always kill a drug — but it usually moves the stock.
An FDA Advisory Committee is a panel of independent experts convened to vote on whether a drug's benefits outweigh its risks. While not binding, the FDA follows committee recommendations ~75% of the time.
Companies with upcoming AdCom meetings often see elevated volatility. Historically, positive votes cause +20–50% moves; negative votes cause -30–70% drops. Sophisticated traders position before the vote.
Not all drugs go through AdCom. The FDA uses committees for novel mechanisms, controversial safety profiles, or first-in-class drugs. The PDUFA date is the FDA's deadline to make the final decision.
A Complete Response Letter (CRL) is FDA's way of saying "not yet." Risk factors: manufacturing issues, clinical trial design questions, safety signals, or committee concerns not addressed.
Not financial advice. AdCom dates sourced from FDA.gov, company filings, and public disclosures. Dates may change without notice. Guerilla Finance Inc.