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Phase 3 trial

The last stage of clinical testing before a drug is submitted for approval.

FundamentalsIntermediate

Definition

Phase 3 studies test a treatment in large numbers of patients, usually against a placebo or the standard of care, to confirm it works and to track safety. Positive results usually lead to an FDA submission.

Watch out for

A meaningful share of late-stage trials fail to meet their goals, and the stock reaction to results can be large in either direction.

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