Module 16 2024

23/10/2024

“Inside Information”

Inside information ● Is of a precise nature ● Is not generally available ● Relates directly or indirectly to an issuer or investment ● Is likely to have a significant effect on price – would a reasonable investor be likely to use the information as part of the basis of his investment decisions?

Safety and efficacy developments may be “inside information”

The Organisation for Professionals in Regulatory Affairs

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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

24

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