Lilly/Icos Cialis Development Strategy: FDA Delays Phase IIIs – Go Overseas
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Lilly/Icos’ Cialis NDA was based on Phase III studies conducted outside the U.S. after FDA advised the firm at an end-of-Phase II meeting to delay pivotal studies until potential testicular toxicity could be investigated, FDA review documents show.
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