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BioWorld - Sunday, January 4, 2026
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Home » Of D-dimers, NDA timers: Portola’s betrixaban push targets second-half filing
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Of D-dimers, NDA timers: Portola’s betrixaban push targets second-half filing

May 31, 2016
By Randy Osborne
After presenting full results from the phase III trial with Portola Pharmaceuticals Inc.’s oral betrixaban for prophylaxis of venous thromboembolism (VTE) in France, study steering committee leader Michael Gibson told BioWorld Today that the company is “beginning to chip away at the chip of the iceberg with respect to the data and will continue to work closely with [the FDA] to explore all their questions.” South San Francisco-based Portola plans to submit a new drug application to the FDA in the second half of this year, and pursue approval in Europe as well.
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