Table: What a Difference a Year Makes
The checkered journey of Erbitux, ImClone's (IMCL ) cancer drug
FEB. 1, 2001
The FDA grants fast-track approval status to Erbitux.
MAY 12, 2001
ImClone reports a 22.5% response in the sickest colon cancer patients in clinical studies.
JUNE 28, 2001
ImClone starts filing a "rolling" approval application with the FDA, submitting sections as they are completed.
SEPT. 19, 2001
Bristol-Myers Squibb (BMY ) agrees to pay $1 billion for a 20% stake in ImClone, plus $1 billion in stages as Erbitux reaches approval.
OCT. 29, 2001
Bristol-Myers deal is completed. The Waksals tender 20% of their shares for $110 million.
NOV. 1, 2001
ImClone finishes its application.
DEC. 6, 2001
COO Harlan Waksal files SEC document to sell 700,000 shares.
DEC. 15, 2001
An FDA committee reviewing the application extends its 45-day deadline to issue a decision.
DEC. 28, 2001
The FDA rejects the Erbitux application.
JAN. 7, 2002
An industry newsletter publishes parts of a leaked FDA letter, indicating that the agency had warned ImClone about the design of its clinical trials more than a year earlier.
JAN. 18, 2002
The same congressional subcommittee that is investigating Enron announces that it will investigate ImClone's conduct of its clinical trials of Erbitux. CEO Sam Waksal is forced to sell 80% of his ImClone shares in margin calls.
JAN. 25, 2002
ImClone receives inquiries from the SEC and the Justice Dept.