(Reuters) - WASHINGTON, July 20 - U.S. drug reviewers will
ask an advisory panel if they should wait for more data before
deciding whether to approve GPC Biotech AG's proposed
prostate cancer pill, 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. The reviewers asked whether one of the main goals
in a GPC study was an acceptable basis for approval, and if
pain measurements were reliable, among other things.
Read more at Reuters.com Government Filings News
ask an advisory panel if they should wait for more data before
deciding whether to approve GPC Biotech AG's proposed
prostate cancer pill, 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. The reviewers asked whether one of the main goals
in a GPC study was an acceptable basis for approval, and if
pain measurements were reliable, among other things.
Read more at Reuters.com Government Filings News
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