News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

Acusphere Inc. (ACUS) Reaches Special Protocol Assessment Agreement with FDA for Imagify(TM) Phase 3 Placebo-Controlled Trial


6/8/2011 10:27:59 AM

LEXINGTON, Mass.--(BUSINESS WIRE)--Acusphere, Inc. (ACUS.PK), a specialty pharmaceutical company, today announced that it had reached an agreement with the U.S. Food & Drug Administration (FDA) regarding the design of a new Phase 3 study of the company’s lead product candidate, Imagify™ Perflubutane Polymer Microspheres for Injectable Suspension. As previously announced, this new study, designed under the Special Protocol Assessment (SPA) process, will compare stress ultrasound with Imagify to stress ultrasound without Imagify for the detection of coronary artery disease (CAD).

Read at BioSpace.com


comments powered by Disqus
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES