(Reuters) - WASHINGTON, July 20 - U.S. drug reviewers have
questioned GPC Biotech AG's 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, the FDA reviewers asked whether one of
the main goals in a GPC study was acceptable for marketing
approval, and whether pain measurements were reliable.
Read more at Reuters.com Government Filings News
questioned GPC Biotech AG's 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, the FDA reviewers asked whether one of
the main goals in a GPC study was acceptable for marketing
approval, and whether pain measurements were reliable.
Read more at Reuters.com Government Filings News
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