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Gentium hopes latest defibrotide response will convince EMA

This article was originally published in Scrip

Executive Summary

Gentium says it has submitted its responses to the Day 180 list of outstanding issues that it received from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) with respect to its marketing authorisation application (MAA) for its only clinical product, defibrotide, to treat a potentially fatal complication related to stem cell transplants.

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