Splitting on Pulminiq

Critics will be ready to pounce if FDA rejects Chiron Corp.'s Pulminiq to prevent lung transplant rejection, as they will be able to cite the well-documented death rate for these patients and the surprising survival result in clinical trial patients treated with the inhaled cyclosporine.

Views on FDA's upcoming decision - the PDUFA date is July 14 - are especially likely to be colored by the agency's admission that it used data dredging to undercut the survival data presented to the Pulmonary-Allergy Drugs Advisory Committee last week...