It's been exactly a month since Sanofi-Aventis dribbled out the news on a Friday evening that the Food and Drug Administration had decided not to allow the much anticipated weight-loss drug Acomplia (rimonabant) to be sold in the United States until certain unspecified conditions are met.
One month later, we know little more about those unspecified conditions -- or what might be involved for Sanofi in trying to meet them. The French pharmaceutical giant has successfully kept any details from leaking about the FDA letter setting out the reasons why it was delaying action on Acomplia.
This tight control of information is something politicians dream about -- not an easy trick for a diverse multinational company. But sources say Sanofi's management in Paris has shared little information about the FDA's concerns about Acomplia with executives in the company's American operating units.
Sanofi only has told analysts it still expects to have Acomplia approved and on sale in the United States as a weight-loss medication in the second half of this year (fat chance, in our view, given Sanofi's unwillingness to shed any light on the holdup), and has said the FDA is not seeking any additional clinical trials as a precondition to approval for weight management.
But at this point, a month later, we do not even know for sure whether Sanofi has had a follow-up meeting with the FDA, and, if so, how it went.
Veteran FDA observers speculate that if Sanofi has had a follow-up meeting with the agency to discuss the Acomplia "dossier," and the meeting went well, we would already have heard the good news. So the lack of any news does not lend itself to speculation that FDA approval of Acomplia is around the corner.
But the financial analysts who follow Sanofi -- and for the most part parrot whatever Sanofi management tells them -- get another chance on Wednesday, March 22nd, to try to find out the realities of where things stand with Acomplia when the company makes a presentation in New York.
Will they press harder than they did on Feb. 24th when Sanofi's Paris management stonewalled while briefing analysts on financial results for 2005? Since they got virtually no information on the future of Acomplia during that session, they can hardly do worse on Wednesday. |