Acusphere, Inc.

AI-700 phase III trials expanded after U.S. FDA meeting

Published in Disease Risk Factor Week, May 15th, 2005

Acusphere, Inc., (ACUS) representatives met with various representatives of the Division of Medical Imaging and Radiopharmaceuticals at the U.S. Food and Drug Administration (FDA).

This division is responsible for reviewing Acusphere's clinical trial results and plans as well as a potential New Drug Application (NDA) for AI-700. The purpose of this meeting was to discuss the rationale behind the phase III clinical design and statistical analysis plan with new members of the division, particularly the new division head, who were not involved in these discussions before the start of phase III pivotal trials, and to receive their feedback.

Acusphere's...

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Source: Disease Risk Factor Week (2005-05-15)

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