Ultrasound contrast developer Acusphere has submitted an amendment to its new drug application (NDA) for Imagify, the Watertown, MA-based vendor said.
The original NDA was submitted to the U.S. Food and Drug Administration (FDA) in April 2008 and filed in June 2008. The amended indication is for patients for whom the risk-to-benefit ratio of Imagify is more compelling than the broader indication that was originally filed. Because this is a significant amendment to Acusphere's Imagify NDA, the company expects the FDA to push back the date for its complete response letter from February 28, 2009, to May 31, 2009.
The company also announced that it has completed the renegotiation of payment terms under certain of its intellectual property agreements. Payments totaling approximately $6.7 million due in 2009 will be reduced to $350,000 immediately, with another $350,000 payable upon a financing of the company, and the remainder due in 2013.
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FDA 'concerned' over Acusphere agent, December 9, 2008
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