Title: Disclosure of the Dealings Between Drug Developing Companies and the FDA Under the Federal Securities Laws (2002 Third Year Paper)
Author(s): Mikko Heinonen
Subject & Subject keywords: Food and Drug Law "FDA" "securities" "disclosure" "approval" "ImClone"
Abstract:The purpose of this article is to highlight the main issues raised by the Food and Drug Administration’s (“FDA”) approval process relating to new drugs and the treatment of this process receives in the context of the Federal Securities Laws . The partial inspiration for this article has been the recent highly publicized case concerning ImClone Systems Incorporated – a case, which well exemplifies both the connection between the valuation of a biotech/medical company and the FDA’s approval process for new drugs, and also the huge effect of the approval process to the market’s valuation of the stock price.