SECTOR RESEARCH // CLASSIFIED F-914

Biotech & Healthcare Analytics

FDA PDUFA binary catalysts, cash-runway metrics, and clinical outcome probability models.

FDA Regulatory PDUFA Binary Catalyst Timeline

AQS Quantitative ForecastRezdiffra (Resmetirom)Target Stage: PDUFA FDA Review

78%

Success Prob Index

Forecast generated using cash burn runways and prior trials profiles.

Core Philosophy

Biotech investing is binary, driven by clinical phase achievements and FDA review outcomes. Instead of guessing trial results, AQS models the implied volatility expansions of options contracts, turning volatile corporate events into highly structured risk plays.

Target Assets

Small and Mid-cap Clinical Phase Developers
Specialized Pharmaceutical Innovators
Medical Device and Diagnostic Providers
Global BioPharma Conglomerates

Primary Data Sources

NIH ClinicalTrials.gov (API)Patient enrollment ratios and testing phase completion dates
FDA PDUFA CalendarsFDA Advisory Committee scheduling and final review deadlines
SEC Cash Burn ReportsFinancial runways compared to clinical trial duration targets

Strategy & Execution

The Setup:

Identify situations where options implied volatility (IV) overstates the historical data movement of a PDUFA decision. Structure a risk-defined Iron Condor or Calendar Spread.

Risk Management:

Close out options positions 15-20 days prior to the binary catalyst date to capture pre-event IV expansion without facing event-day gap down risk.