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Acusphere, Inc.
Acusphere Receives Complete Response from FDA
March 27th, 2009
Acusphere, Inc. announced that it has received a complete response from the U.S. Food & Drug Administration (FDA). The response was largely consistent with the feedback received at the Advisory Committee meeting on December 10, 2008, and discussions that continued with FDA in January 2009. In general, their response suggested that additional clinical work would be required to support the original broad claim. As previously announced, The Company also submitted in February 2009 a narrower claim with a potentially improved risk-to-benefit ratio. The Company was also invited by FDA to schedule a meeting to discuss alternatives. The Company is in the process of scheduling the meeting. About...
Source: Health Business Week (2009-03-27)
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