Executive Summary

An FDA "complete response" letter for Acusphere's Imagify suggests that additional clinical work will be required to support its proposed use as a screening tool to stratify patients for referral to coronary arteriography, the firm announces March 11. The company says the letter is largely consistent with the feedback it received from an FDA advisory committee in December; the panel voted 16-1 with one abstention against Imagify approval due to evolving trial design standards, miscommunication with the FDA review division, inconsistent efficacy, safety signals and unconvincing diagnostic value (1"The Pink Sheet," Dec. 15, 2008, p. 17). Acusphere submitted a narrower claim for the imaging agent in February with a potentially improved risk-benefit ratio, and is in the process of scheduling a meeting with FDA to discuss alternatives