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Article: Guilford Begins Phase III Program For Aquavan Injection In Sedation.
- Article from:
- BIOWORLD Today
- Article date:
- November 3, 2009
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Washington Editor
Guilford Pharmaceuticals Inc. on Monday said it initiated a Phase III development program for Aquavan Injection, a candidate for procedural sedation.
The decision to enter Phase III follows the firm's end-of-Phase II meeting with the FDA. Data from the 64-patient Phase II trial are expected in the second quarter, Stacey Jurchison, director, corporate communications of Baltimore-based Guilford, told BioWorld Today.
Meanwhile, Guilford expects the Phase III program to be completed in 2005. Under the best of circumstances, the firm will file a new drug application based on data from 1,200 patients (including data from Phase I ...