Gentium S.p.A.(GENT) announced, following the oral explanation, based on preliminary feedback from the European Medicines Agency's or EMA Committee for Medicinal Products for Human Use or CHMP, that it expects an opinion recommending against approval of the Marketing Authorization Application for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy.
While not a final decision, the company said it considers it unlikely that this position will change before the formal vote is undertaken next month. If a formal negative recommendation is issued, and depending upon the nature of the objections, the company may appeal such negative decision.
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