Genentech To Resubmit Avastin sBLA In Mid-2007
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA is seeking substantially more information than expected from an NCI-sponsored trial for first-line treatment of metastatic breast cancer, the company says.
You may also be interested in...
Handicappers Debate Chances Of Genentech’s Avastin In Breast Cancer
As clock ticks down to tomorrow’s user fee date for Avastin, “ambivalent and ambiguous” agency hard to outguess, analyst tells “The Pink Sheet” DAILY.
Handicappers Debate Chances Of Genentech’s Avastin In Breast Cancer
As clock ticks down to tomorrow’s user fee date for Avastin, “ambivalent and ambiguous” agency hard to outguess, analyst tells “The Pink Sheet” DAILY.
FDA Panel To Discuss Genentech's Avastin Use In Metastatic Breast Cancer
Oncologic Drugs panel considers whether progression-free survival can support approval for Avastin absent an overall survival benefit.