Comunicati della casa madre?, Tacciono ?
Sicuramente è stato letto , ma nel dubbio lo posto;
Da Fineco: 16 a 1 il verdetto negativo.........
SILVER SPRING, Md., May 12 (Reuters) - NicOx SA's (COX.PAR) prescription arthritis drug should not be approved for the U.S. market because there is not enough safety data to back its use, a U.S. Food and Drug advisory panel said on Wednesday.
France's top biotech company is seeking FDA's approval to market its pain drug, called naproxcinod, to treat patients with osteoarthritis with the claim it has fewer heart risks compared with certain rivals.
But the agency's panel of outside medical experts, in a 16-1 vote, said there was not strong enough data from the company's small trials to back safe use of the drug, which could mostly be in older patients with other health problems.
The FDA will weigh the panel's vote before making its final decision, which is expected by July 23.