Replies to post #72686 on Biotech Values

[ghmm]

ITMN:

thers were what the company deemed "exploratory," which means they were done after the data had been collected

Glad you pointed that out I noticed that but thought I already came across as an Adam basher :-)

Technically he is correct about the size of the trials but considering the high dose arms are the only ones included in the analysis they were the same size too but I don't want to appear nit-picky :-)

[jbog]

ITMN,

Could Adam be referring to something different. In Intermune's meeting yesterday it presented positive "exploratory" results in dealing with the trials. When both trials were written they both had a concrete "Zero to 72 week" timetable, in other words all final results were supposed to be measured at week 72. In their "exploratary analysis" they deviated the timeline and this was not preplanned.

To better understand the primary efficacy outcome, InterMune conducted a series of exploratory analyses interrogating the time course of treatment effect. An exploratory repeated measures analysis of ranked change from baseline, assessing treatment effect over the full duration of the study suggested pirfenidone reduced the decline in FVC in both studies (CAPACITY 2 p = 0.004 and CAPACITY 1 p = 0.001). In both studies, the magnitude of treatment effect generally was most pronounced in the first 48 weeks of treatment. For example, in CAPACITY 2 and CAPACITY 1 the Week 48 rank ANCOVA p values were 0.001 and 0.005; the relative reductions in LS means from the repeated measures analysis were 46% and 29%, respectively. The difference between the CAPACITY 2 and CAPACITY 1 primary endpoint results at Week 72 may have been due to a modest attenuation in the rate of FVC decline in the placebo group subsequent to Week 48 in CAPACITY 1.