Placebo or Panacea: The FDA's Rejection of ImClone's Erbitux Licensing Application

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Placebo or Panacea: The FDA's Rejection of ImClone's Erbitux Licensing Application

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Hron, Benjamin M. en_US
dc.date.accessioned 2012-06-15T20:18:48Z
dc.date.issued 2003 en_US
dc.identifier.citation Placebo or Panacea: The FDA's Rejection of ImClone's Erbitux Licensing Application (2003 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8889445
dc.description.abstract This paper draws upon the media reports, congressional hearing testimony, and company press releases to recount events surrounding the FDA’s refusal to issue a license to ImClone’s cancer drug Erbitux, late in 2001. Erbitux was granted fast-track status by FDA, and was evaluated under the agency’s accelerated approval process. Despite hype about the drug’s effectiveness in fighting certain types of cancer, the FDA found numerous and considerable problems with the licensing application, and in particular with the conduct and documentation of the main registration trial. The paper discusses the possibility that ImClone’s public statements may have misled investors, and the ability of the FDA and the SEC to oversee these disclosures. Finally, recent changes in the FDA approval process are addressed, as well as the current state of ImClone’s continuing attempts to gain licensing approval for Erbitux. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject ImClone en
dc.subject Erbitux en
dc.subject Waksal en
dc.subject insider trading en
dc.subject public disclosure en
dc.subject licensing application en
dc.subject biologics en
dc.title Placebo or Panacea: The FDA's Rejection of ImClone's Erbitux Licensing Application en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-06-15T20:18:48Z

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