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FDA Cardio-Renal Division Accepts Neurochem’s Fibrillex For Pilot 2 Program

This article was originally published in The Pink Sheet Daily

Executive Summary

Selection for the continuous marketing application program could expedite review of the amyloidosis treatment, which is targeted for NDA filing in 2005. The pilot 2 program builds upon an earlier collaboration between Neurochem and FDA through which the agency provided funding for a Fibrillex Phase II/III clinical trial.

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