BioCentury
ARTICLE | Company News

Erbitux timeline not addressed at IMCL meeting

June 11, 2002 7:00 AM UTC

ImClone (IMCL) President and CEO Harlan Waksal said in his prepared comments at the company's annual shareholder meeting that "it is not appropriate to comment on the timing of our refiling of the BLA" for the anti- EGFR antibody to treat colorectal cancer. On Thursday, the House Energy and Commerce Subcommittee on Oversight and Investigations will hold a hearing on Erbitux. Witnesses scheduled to testify include: Harlan Waksal and former IMCL CEO Samuel Waksal; Laurie Smaldone, SVP of global regulatory sciences at Bristol-Myers (BMY); and Brian Markison, VP in the division of oncology at BMY who subcommittee staff say received information about the FDA's decision to refuse to accept the Erbitux filing four days before the official notification. ...