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NicOx stock hit again; complete response letter for naproxcinod from FDA

July 26, 2010 7:00 AM UTC

NicOx S.A. (Euronext:COX) fell €0.60 (21%) to €2.24 and shed €43.3 million ($55.9 million) of market cap last Thursday after FDA issued a complete response letter for the company's NDA for naproxcinod to treat the signs and symptoms of osteoarthritis (OA).

The letter wasn't a surprise, as an FDA advisory panel in May voted 16-1 with one abstention against approval. After the committee vote, NicOx shares lost €3.97 (58%) to €2.82(see BioCentury, May 17). ...