FDA treads water on Effient (prasugel) approval

The blockbuster blood thinner Plavix from Bristol-Myers Squibb (BMY) and Sanofi-Aventis (SNY), looks under even less of a threat from Lilly's Effient (prasugel) --which the FDA is going to kick back to one and maybe two, advisory committees early next year.

Advisory committees are outside panels of industry "experts" that review products for the FDA, (removing responsibility from as well) usually when there are safety and/or efficacy concerns, who then (eventually) make elusive and non binding recommendations and leave it (much later) for the FDA to think what to do.

In tests reporteed so far Effient (prasugel) works as well or better than the Plavix but there is a downside that it may cause some patients to bleed internally too much.

New CEO John Lechleiter wason CNBC's David Faber on "Squawk on the Street" from the Business Council's meeting in South Carolina and revealed he was unable to provide timing on an FDA decision.