Editing Samuel D. Waksal (section)

==ImClone Systems==
Waksal founded [[ImClone Systems]] in 1984. The company was engaged in several research and development projects before filing its first [[Biologic License Application]] with the FDA in 2001. When it won the rights to develop Erbitux, a cancer antibody, the drug's clinical success caused ImClone's stock to reach a high of $70 a share. In September 2001, [[Bristol-Myers Squibb]] was intrigued enough by Erbitux to sign a $2 billion deal with the company in return for the marketing rights to the drug.<ref name=app>{{cite news|url=https://www.nytimes.com/2004/02/13/business/technology-imclone-cancer-drug-behind-martha-stewart-trial-is-approved-by-fda.html|title=Technology; ImClone Cancer Drug Behind Martha Stewart Trial Is Approved by F.D.A.|newspaper=The New York Times|first=Andrew|last=Pollack|date=February 13, 2004|access-date=August 29, 2016}}</ref> In December 2001, however, the FDA issued a ''Refuse to File''<ref>{{cite web|title=Refusal to File Procedures for Biologic License Applications|url=https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ProceduresSOPPs/ucm073474.htm|publisher=US Department of Health and Human Services|access-date=9 December 2012}}</ref> decision effectively turning down ImClone's application due to concerns about the structure of the clinical trials.<ref name=NYT/> In 2004, Erbitux was approved by the FDA.<ref name=app/> In 2008, the drug generated over $1.5 billion in sales and was credited with aiding thousands of cancer patients. That same year, ImClone was sold to [[Eli Lilly and Company]] for $6.5 billion.<ref name=nymag>{{cite magazine|url=http://nymag.com/news/features/55340/index1.html|title=Sam Waksal was Right All Along* |magazine=New York Magazine|first=Robert|last=Kolker|date=March 15, 2009 |access-date=August 29, 2016}}</ref>