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Re: None

Tuesday, 03/07/2006 8:10:02 PM

Tuesday, March 07, 2006 8:10:02 PM

Post# of 126
There are a number of news items which have given the incorrect info about the panels voting. The panel unanimously approved to use of daptomycin in both bacteremia and endocarditis. The 5-4 split vote was over the labeling requirements that members felt had to be developed. These discussions will continue with Cubist and the FDA having to do some real soul searching to get these correct. Labeling is vital to the treating physician and in the case of these two very dangerous diseases it will be a most difficult chore that I expect shall take a few months. Agreement on this has to be reached before the FDA will act and hopefully grant approval to market Dapto.