Market response to FDA announcements

This study investigates announcement effects at four points in the Food and Drug Administration (FDA) review process and explores conditions that may impact final approval. We show that investors adjust expectations through the approval process, and most uncertainty is resolved by final approval. While smaller firms reap benefit from the approval, the market penalizes first movers. We do not find additional gain for pioneering research, implying that these firms may be able to reduce R&D spending.

本研究调查了美国食品药品监督管理局（FDA）审查过程中四个时间点的公告效应，并探讨了可能影响最终批准的条件。我们发现，投资者在审批过程中调整预期，且大部分不确定性在最终批准时得以消除。虽然较小的公司从批准中获益，但市场对先行者不利。我们没有发现开创性研究有额外收益，这意味着这些公司或许能够减少研发支出。