Catalyst calendar

• FDA decisionThe date by which the FDA has to decide whether to approve a drug (the “PDUFA date”).
• FDA panelOutside experts advise the FDA on a drug. The FDA usually, but not always, follows their vote.
• Trial resultsA company reports what a clinical trial showed. Often the biggest single mover.
• ApprovalA regulator (FDA, EU, UK, Japan) approves a drug for sale.
• Not approvedThe FDA said “not yet” and listed what has to be fixed (a “complete response letter”).
• ConferenceNew data shown at a medical meeting.
• MilestoneA company milestone such as a filing, a submission or a trial starting.
• Trial endsA trial is scheduled to finish collecting its main data (from ClinicalTrials.gov). Results come weeks or months later.
• Results postedDetailed results were posted to ClinicalTrials.gov, usually long after the announcement.

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