Sanofi-Aventis said August 2nd it is "still hopeful and confident" that its highly anticipated diet pill Acomplia (rimonabant), stalled by unidentified issues at the U.S. Food and Drug Administration, will be available for purchase in the United States by the end of the year.

But Hanspeter Spek, head of pharmaceutical operations, as usual provided no details as to what has been holding up FDA action on Acomplia since February. And at this point, virtually no one else shares Sanofi's optimism.

Spek said only that Sanofi continues to talk to the FDA in a "very intense and regular manner" about Acomplia, and said he did not know if the FDA would convene an advisory panel of experts to review the diet drug before making a decision on approval.

"We have no information at all on an advisory committee, and my understanding is that an advisory committee always could appear but today we have not the slightest indication that the FDA has done so," Spek said.

"We are still hopeful and confident we can launch Acomplia before the end of 2006" in the U.S., Spek said during a conference call with financial analysts.

A number of observers who have been hearing these optimistic pronouncements from Sanofi about the likelihood of early FDA approval for more than a year seemed more skeptical about the prospects of Acomplia making it to the market in the United States in 2006.

"We believe the drug may not launch until sometime in the first half of 2007,'' Prudential analysts said in a note to clients two days ago. "It may have to go up before an FDA Advisory Committee first, something we think investors may have lost sight of.''

Most FDA observers agree with that assessment, but at this point, the FDA advisory panel that would consider Acomplia has no meeting scheduled to consider issues involved with rimonabant between now and the end of the year.

Sanofi began selling its diet drug for the first time at the end of June in Britain, and Spek said "we have had a very, very positive first response from very very positive first response from the doctors that have been using it the past three weeks." He said, however, that there was not enough sales data from the first month to assess the success of the U.K. launch.

Spek said Sanofi also hopes to launch Acomplia in Germany in the next three weeks, and roll out the prescription weight-loss pill in about a half dozen other European countries during the remainder of the year.

But the huge U.S. weight-loss market -- where unlike Europe, Sanofi will be able to pour millions of dollars into consumer advertising for the prescription pill -- remains key to rimonabant becoming a blockbuster drug, and Sanofi continued to provide no information on the issues holding up FDA approval.

"It is a permanent dialogue between the agency and us that we submit information, and then the FDA may ask additional questions on the basis of what has been submitted," was the most Spek would say.