Published in Medical Letter on the CDC and FDA, June 21st, 2006
The company also announced it remains on track to initiate the phase III clinical trial in Q2 2006. CoFactor is a biomodulator drug designed to improve the efficacy and safety of the widely used chemotherapeutic agent, 5-fluorouracil (5-FU).
The SPA documents the FDA's agreement that the design and planned analysis of the phase III study adequately address the objectives necessary to support a regulatory submission for...
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