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Encysive To Enter Dispute Resolution With FDA Over Third Thelin “Approvable” Letter

This article was originally published in The Pink Sheet Daily

Executive Summary

Company asserts that FDA’s data analysis of STRIDE-2 trial for Thelin does not follow special protocol assessment agreement.

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Encysive Dispute Resolution Request For Thelin Negged By FDA

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Securing approval by conducting an additional Phase III study as requested by FDA would take years, CEO Cole tells “The Pink Sheet” DAILY.

Encysive To Cut U.S. Work Force By 70 Percent To Curb Cash Flow

Company also appoints George Cole to CEO, replacing Bruce Given, following on the heels of an FDA “approvable” letter for Thelin.

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