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Neurochem Submits First Unit Of Fibrillex Rolling NDA

This article was originally published in The Pink Sheet Daily

Executive Summary

The amyloid A amyloidosis agent is part of the Pilot 1 and Pilot 2 programs overseen by FDA's Division of Cardio-Renal Drug Products.

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Neurochem Gets FDA Priority Review For AA Amyloidosis Drug

Filing for Fibrillex in Europe awaits accelerated orphan drug pathway, but could come in fall 2006.

Neurochem Gets FDA Priority Review For AA Amyloidosis Drug

Filing for Fibrillex in Europe awaits accelerated orphan drug pathway, but could come in fall 2006.

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

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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