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For the millions of American's wondering when highly anticipated diet pill Acomplia (rimonabant ) may be obtainable in the United States, the next opportunity for developer Sanofi-Aventis to update the world on where things really stand with the U.S. Food and Drug Administration comes on August 2nd. That's the date Sanofi's top executives plan to meet with financial analysts to report on the company's first half 2006 earnings, after which the analysts get a chance to ask questions. It's been more than five months now since Sanofi-Aventis dribbled out the news that the FDA had decided not to allow Acomplia to be sold in the United States until certain unspecified conditions are met. At past sessions of this kind, Sanofi has brushed aside all questions about why the FDA was delaying action on Acomplia, telling analysts only that it was responding to the FDA, and expected to have Acomplia approved and on sale in the United States as a weight-loss medication in the second half of this year. The likelihood of that now happening, in the view of most observers, is very close to zero. So given Sanofi's financial stakes in getting what they foresee as a $5 billion drug into the U.S. market, we would hope analysts might be a bit more aggressive in seeking to determine when the Acomplia revenue stream (and the availability of the drug to U.S. patients) might start. Sample question for analysts: What issues are holding up approval at the FDA? While Acomplia has been on the market now in the U.K. for just over a month, and is expected to be launched in a half-dozen other European markets in the months ahead, the revenue the drug will produce for Sanofi during the balance of this year is trivial compared to what is at stake in the United States. Sample follow-up question for analysts: Have you had have any indication when Acomplia will be considered by an FDA advisory committee? Source:Acomplia Report
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