Sanofi-Aventis -- in a puzzling statement that comes close to defying both the calendar and belief -- reiterated on October 6th that diet drug Acomplia (Rimonabant) was on track for launch in the United States before the end of 2006,

A Sanofi spokesman told the Reuters news agency that the company remains in constant discussion with the U.S. Food & Drug Administration (FDA) about Acomplia, which probably will be marketed as Zimulti in the U.S., and said there has been no change to what Sanofi said about the drug back on Aug. 2nd.

Hanspeter Spek, head of pharmaceutical operations, on Aug. 2 told analysts that Sanofi was still "hopeful and confident " the FDA would approve Acomplia for sale in the United States before the end of this year, but as usual provided no details as to what has been holding it up since February.

The latest Sanofi non-statement came after the Bloomberg news agency reported that Sanofi was collecting data on use of Acomplia by European patients that could help persuade the FDA that product was safe.

Sanofi started selling Acomplia in the U.K. in June and has been speaking to doctors and patients in the U.K., Germany and a couple other European countries where the drug is now on sale, according to Doug Greene, the company's chief medical officer.

The information Sanofi is collecting from them helps track side effects or risks that may emerge during a drug's first months on the market, Greene said, noting that "rare events are difficult to discern during a clinical trial period.

"The FDA has become very cautious,'' Greene told Bloomberg at a forum on drug research and development in Berlin. "We're working very closely with them and helping them in their interpretation of the data. We think when it completes its review, Acomplia will be found to be safe and effective.''

The Bloomberg article, which raised concern in investment circles that the FDA may be seeking more data before acting on approval of Acomplia for sale in the U.S., sent Sanofi shares skidding on European markets.

But a Sanofi spokesperson denied that the FDA had asked for the data. "We are collecting data in Europe on the secondary effects of Acomplia. It's a typical process, but we have not been asked by the FDA for this data," the spokesperson said.

The latest questions about Acomplia have been snowballing since a research analyst who has been one of the biggest boosters of Sanofi and diet drug Acomplia sent a note to investors saying the company had gone silent to most investors, analysts and the media, and would remain quiet until it announces quarterly financial results on Oct. 31.

This decision not to let anyone know what is going on gives Sanofi's shareholders "plenty of reason to be nervous," Forbes magazine reported on October 5th.

U.S. approval of rimonabant, Forbes notes, has been delayed for seven months and counting.