Advisory Committee meetings (AdComs) are public meetings where independent experts evaluate drug applications and provide recommendations to the FDA. They are among the most watched events in biotech.
FDA Advisory Committees are panels of outside experts who provide independent advice on scientific, technical, and policy matters. While their recommendations are non-binding, the FDA follows their guidance approximately 75-80% of the time.
| Committee | Abbreviation | Focus Area | |-----------|--------------|------------| | Oncologic Drugs Advisory Committee | ODAC | Cancer treatments | | Cardiovascular and Renal Drugs | CRDAC | Heart and kidney drugs | | Endocrinologic and Metabolic Drugs | EMDAC | Diabetes, obesity | | Peripheral and Central Nervous System | PCNS | Neurological drugs | | Antimicrobial Drugs | AMDAC | Antibiotics, antivirals | | Pulmonary-Allergy Drugs | PADAC | Respiratory conditions |
Not all drug applications require an AdCom. The FDA typically calls one when:
Pro Tip: If FDA calls an AdCom, it often signals uncertainty. However, drugs can still be approved even after a negative vote.
Advisory Committee meetings follow a structured format:
Morning Session (8:00 AM - 12:00 PM)
Afternoon Session (1:00 PM - 5:00 PM)
| Document | Timing | Content | |----------|--------|---------| | Briefing Document (Sponsor) | 2-3 days before | Company's case for approval | | Briefing Document (FDA) | 2-3 days before | FDA's analysis and concerns | | Questions for Committee | 2-3 days before | Specific questions to be voted on |
Yes/No Questions
Scoring Questions
| Vote Outcome | Typical Market Reaction | |--------------|------------------------| | Strong Yes (>70%) | Positive, stock rises | | Narrow Yes (50-70%) | Mixed, volatility | | Narrow No (40-50%) | Negative but hope remains | | Strong No (below 40%) | Significantly negative |
Important: AdCom votes are non-binding. The FDA has approved drugs after negative votes and rejected drugs after positive votes.
Strategy: Reading FDA briefing documents carefully can provide insights into the agency's concerns before the meeting.
Based on historical data:
| Metric | Approximate Rate | |--------|-----------------| | FDA follows positive vote | ~85% | | FDA follows negative vote | ~70% | | Approval after negative vote | ~25% | | Rejection after positive vote | ~5% |
Advisory Committee meetings are critical catalysts that provide insight into FDA thinking:
