Module 16 2022

02/09/2022

Case Study – Rogaine (Minoxidil) Upjohn briefed investigators on phase III study results ● Concerns about insider trading

Press release over-stated significance of data and product’s efficacy

A letter from the FDA claimed the press release was misleading and false

The value of stock plummeted

● shareholder and SEC actions

The Organisation for Professionals in Regulatory Affairs

27

Case Study – Rogaine/Minofidil: Extracts from FDA correspondence

The Organisation for Professionals in Regulatory Affairs

28

14