The Signaling Effects of the US Food and Drug Administration Fast-Track Designation

Autor: George H. Pink, Clark Nardinelli, Kristin L. Reiter, Kathleen L. Miller
Rok vydání: 2016
Předmět:
Zdroj: Managerial and Decision Economics. 38:581-594
ISSN: 0143-6570
DOI: 10.1002/mde.2805
Popis: Pharmaceutical firms are reluctant to disclose proprietary information about a drug's likelihood of approval by the U.S. Food and Drug Administration (FDA) for fear of losing their competitive advantage. Instead, firms may use signals, like the FDA fast-track designation, to indicate to investors the likelihood of a drug's approval. This analysis uses an event study methodology, with stock and market data from the Center for Research in Security Prices. The results show that the fast-track designation is a strong, positive signal to investors (1998–2015), but its strength has markedly decreased over time. Results also show that the signal is strongest for the smallest firms. Copyright © 2016 John Wiley & Sons, Ltd.
Databáze: OpenAIRE