Acusphere Left Unstable By FDA Panel Review; CEO Turns Ire On Panelists
Executive Summary
Acusphere is evaluating its viability after an FDA advisory panel voted against its lead product Imagify Dec. 10, and amid failing investor confidence. CEO Sherri Oberg held an emotional next-day conference call to discuss next steps for the Watertown, Mass.-based firm
You may also be interested in...
Acusphere Future Up In Air After Imagify Fails Before Advisory Panel
Evolving trial design standards and miscommunication with the review division tripped up Acusphere's effort to bring Imagify to market, signaling to competitors in the space that FDA is raising the bar on contrast imaging agents
Acusphere Future Up In Air After Imagify Fails Before Advisory Panel
Evolving trial design standards and miscommunication with the review division tripped up Acusphere's effort to bring Imagify to market, signaling to competitors in the space that FDA is raising the bar on contrast imaging agents
Acusphere Secures Funding From Cephalon To See Imagify Through PDUFA
Cephalon gains option to license the cardiovascular imaging drug, as well as rights to an injectable formula of celecoxib in preclinical development.