Erbitux Head And Neck Cancer Application Slated For Third Quarter Filing
This article was originally published in The Pink Sheet Daily
Executive Summary
Firms originally planned a second quarter submission, but delayed to allow for an independent review of the Phase III trial. The review confirms the study met its primary efficacy endpoint of locoregional control.
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ImClone/Bristol Seek Priority Review For Erbitux Head And Neck Cancer Indication
Erbitux sBLA filing for head and neck cancer follows independent confirmatory review of Phase III trial.
Erbitux sBLA For Head And Neck Cancer Delayed By "Independent Review" Process
ImClone and Bristol-Myers Squibb originally intended to submit supplemental BLA by second-quarter 2005. ImClone now anticipates filing in the fourth quarter following an additional review of the Phase III study's primary endpoint. Delay means ImClone will miss milestone payment.