Wells Fargo Securities Rates InterMune (ITMN) Market Perform
Wells Fargo Securities analysts Aaron Reames and Matthew J. Andrews rated shares of InterMune, Inc. (Nasdaq: ITMN) Market Perform.
The analysts questioned whether or not the FDA would accept InterMune's use of Forced Vital Capacity, as opposed to Overall Survival as the appropriate endpoint for the CAPACITY studies of pirfenidone (proposed brand name Esbriet) as a treatment for idiopathic pulmonary fibrosis.
The Wells Fargo Securities analysts wrote, "although the briefing documents may have read much better than we and many on the Street anticipated, InterMune is not out of the woods yet. Due to the conflicting efficacy data presented in the FDA briefing documents for CAPACITY 1 and CAPACITY 2, approval of pirfenidone (pr0posed brand name Esbriet) essentially comes down to whether or not the panel on 3/9/10 and subsequently the FDA are convinced that the 52% reduction in the risk of death from pooled data from both studies for IPF-related deaths [HR=0.48, (95% CI 0.24, 0.95); p=0.035] is truth, instead of a spurious outcome."
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