Thanks, Peter. Did you buy management's answer (Harkonen passed the question to Pennington, I think) to the question as to why there should be statistical significance as to survival/mortality if there was only 10% difference between placebo as to disease-free progression? Pennington's answer was to the effect (my feeble attempt to paraphrase) that there was sufficient pharmokinetic activity from actimmune such that collateral effects of ipf, such as bronchitis and other lung-related conditions, were resolved such that deaths attributable to these collateral conditions (made worse by ipf) but not ipf itself were reduced. Pennington hedged by saying that the data were preliminary and that this was a valid question. (That part of the call got me very nervous.)
Also, as to the primary endpoint:
The primary endpoint was progression free survival time defined as either one of the following: (i) a decrease in forced vital capacity (FVC) of >10 percent, (ii) an increase in A-a gradient of 5 mmHg, or (iii) death. While this endpoint did not reach statistical significance, there was a trend in favor of Actimmune-treated patients, representing an approximately 10% relative reduction in the rate of progression-free survival versus placebo.
I assume that in the case of FVC, the endpoint sought to be reached was 10% average reduction in all patients in the trial, versus 10% relative reduction versus placebo. Does this mean the endpoint was just missed or that only 10% of patients in the trial showed progression-free survival on any of the three prongs?
tia,
quid |
