Biotech Catalyst Research: FDA Decision Analysis for Investors

Referenced research reports explaining upcoming FDA decisions for readers without a medical background, covering more than 100 decisions to date. Each report assesses seven areas: mechanism, pivotal trial data, competition, manufacturing, cash and runway, market access, and the options-implied move. The method uses primary sources, explains trial limitations in plain language, and makes the numbers traceable. Two anonymized examples show the report structure, with figures as reported at the time of writing.