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Article: Sonus, FDA Agree To Terms For Tocosol Paclitaxel SPA.
- Article from:
- BIOWORLD Today
- Article date:
- November 3, 2009
CopyrightCOPYRIGHT 2009 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Washington Editor
Sonus Pharmaceuticals Inc. is moving forward with pivotal development plans for its lead product, Tocosol Paclitaxel, after completing a special protocol assessment for a single Phase III trial.
"It really is a very important milestone for us," Sonus President and CEO Michael Martino said, "and for what our team has been working very hard to achieve."
He added that the FDA-approved plan also validates the company's regulatory strategy, which should appeal to investors and potential partners. Sonus, which has long planned to seek a partner for the product's late-stage development and commercialization, had $15.1 million in cash ...