Module 16 2024

23/10/2024

Case Study – Rogaine/Minofidil: Extracts from FDA correspondence

The Organisation for Professionals in Regulatory Affairs

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Consequences of a Failure to Report

Heavy financial penalties (the company, officers or connected persons)

Authorities may de-list or suspend trading

Offences like insider dealing and market abuses carry heavy criminal penalties

● Penalties for insider dealing: – UK: unlimited fines and/or up to 7 years imprisonment – US: fines of up to $5 million and/or up to 20 years – US civil penalties include up to 3 times trading gains or losses avoided

Could lead to shareholder litigation – damages are substantial

The Organisation for Professionals in Regulatory Affairs

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