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Biotech / Medical : InterMune (nasdaq)ITMN

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To: tom pope who wrote (304)	9/3/2002 5:29:46 PM
From: rkrw	Read Replies (1) of 508

I think itmn did as best as could be expected given the very limited data and precedent in ipf. IMO their intentions and execution were excellent. They consulted top ipf physicians to design the trial, they overenrolled the study, they held the dropout rate to less than half what was built in. The problem imo, was that there is such a poor precedent and dearth of historical data in ipf and ipf clinical trials, that they had to create the regulatory path to take. This obviously creates risk that the trial won't be optimally designed. I bet they were also a bit fooled by the incredibly strong austrian/vienna results, I know I was :-). They essentially mirrored the successful but very small austrian trial. Using such a small trial as essentially a phase II will always create phase III risk. Incidentally, I was told some time ago that the fda had initially asked itmn to run a multi-year trial with survival as the primary endpoint (ala cancer). I was told itmn balked thinking that this would take several years and was impractical and probably impossible given the off label accessibility. If the original fda request is indeed true, maybe, ironically it will be helpful in gaining the ipf indication.

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