Disclosure of the Dealings Between Drug Developing Companies and the FDA Under the Federal Securities Laws

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Disclosure of the Dealings Between Drug Developing Companies and the FDA Under the Federal Securities Laws

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Title: Disclosure of the Dealings Between Drug Developing Companies and the FDA Under the Federal Securities Laws
Author: Heinonen, Mikko
Citation: Disclosure of the Dealings Between Drug Developing Companies and the FDA Under the Federal Securities Laws (2002 Third Year Paper)
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Abstract: The purpose of this article is to highlight the main issues raised by the Food and Drug Administration’s (“FDAâ€) 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.
Terms of Use: This article is made available under the terms and conditions applicable to Other Posted Material, as set forth at http://nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of-use#LAA
Citable link to this page: http://nrs.harvard.edu/urn-3:HUL.InstRepos:8852181

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