Plenaxis "not approvable" response
Executive Summary
Praecis says it will consider conducting additional clinical trials following Sept. 10 meeting with FDA to discuss "not approvable" letter for Amgen/Praecis' prostate cancer treatment Plenaxis (abarelix). Possible trials would evaluate the use of currently available hormonal therapies in patients first treated with Plenaxis. Praecis will also conduct a re-analysis of allergic reactions using existing clinical data
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