Aurinia Pharmaceuticals Inc (AUPH)

[biotech_researcher]

Important document from the FDA's web site that highlights the chances of success in phase 3 trials:


Phase 1

Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.
Length of Study: Several months

Purpose: Safety and dosage

Approximately 70% of drugs move to the next phase


Phase 2

Study Participants: Up to several hundred people with the disease/condition.
Length of Study: Several months to 2 years

Purpose: Efficacy and side effects

Approximately 33% of drugs move to the next phase


Phase 3

Study Participants: 300 to 3,000 volunteers who have the disease or condition
Length of Study: 1 to 4 years

Purpose: Efficacy and monitoring of adverse reactions

Approximately 25-30% of drugs move to the next phase