US drug reviewers question GPC Biotech cancer drug Fri Jul 20, 2007 9:32AM EDT WASHINGTON, July 20 (Reuters) - U.S. drug reviewers have questioned GPC Biotech AG's (GPCG.DE: Quote, Profile, Research) study of a proposed prostate cancer pill and will ask an advisory panel if officials should wait for final survival data before acting on the company's application, a summary released on Friday said.
Food and Drug Administration staff raised five issues with GPC's application for the drug Orplatna, known generically as satraplatin. Among them, they asked whether one of the main goals in a GPC study was acceptable for marketing approval, and whether pain measurements were reliable. (Reporting by Lisa Richwine) ....
Finde aber sonst nichts wo diese Behauptung von REUTERs gestützt würde. Komisch...
|