fuss schreef:
Leiden, The Netherlands, December 13, 2007. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) announced today that it has been informed by the European Medicines Agency (EMEA) that the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the Marketing Authorization Application (MAA) for Rhucin®. On the basis of currently available information, Pharming understands that the CHMP was not reassured that there was sufficient evidence to confirm the benefits of Rhucin in laryngeal sub-mucosal attacks, or how safe and effective the medicine is when given to a patient more than once. Pharming intends to apply, later this month, for a re-examination of the CHMP opinion in accordance with relevant procedural guidelines of the EMEA. A final opinion of the CHMP after re-examination is expected in the first half of 2008.