In the absence of any real news on where the FDA decision process stands on the new anti-obesity drug Acomplia (rimonabant), speculation has begun to focus on whether a key agency advisory committee will consider the merits of the drug at a January meeting.

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which reviews and evaluates data concerning the safety and effectiveness of investigational drugs for use in the treatment of endocrine and metabolic disorders, now has its next meeting tentatively scheduled for January 23rd.

The developer of a drug, Sanofi-Aventis in the case of Acomplia, would need to be invited to attend 60 days in advance of any meeting where the drug was to be discussed, and there has been no word as to whether it has been invited to the Jan. 23rd committee meeting.

The FDA also as of December 8th had not publicly released an agenda for that meeting. Casting further doubt on the likelihood of Acomplia being discussed is the fact that the January 23rd session is at this point billed as a joint meeting with the Nonprescription Drugs Advisory Committee.

If the Endocrinologic and Metabolic Drugs Advisory Committee does not consider Acomplia in January, its next meeting is tentatively scheduled to be held May 3-4, 2006.

Most observers believe it highly unlikely that the FDA would approve a novel drug that is the first endocannabinoid-receptor inhibitor to be brought before it without any input from one of its advisory committees.

All that would seem to lower our level of confidence in a CNN report December 2nd quoting a research analyst as projecting a February decision by the FDA on approval of Acomplia.

Gbola Amusa, a much-quoted research analyst who tracks the pharmaceutical industry for for the firm Sanford Bernstein & Co. in London, projected the optimistic timeline while talking to CNN about FDA action December 2nd on the Sanofi-Aventis cancer drug Taxotere.

CNN shed no light on whether Amusa shared with them the basis for his optimism, and efforts to contact him directly have thus far been unsuccessful.

Stay tuned.