Replies to post #2049 on Biotech Values

[DewDiligence]

>> Median survival was assesses in the iressa trial; it just wasn't a primary endpoint. <<

The Iressa trials in refractory NSCLC were not powered to detect a statically significant increase in median survival; rather, they were powered merely to detect a statistically significant increase in response rate (two-dimensional tumor shrinkage of 50%+ lasting at least one month).

At this point, we don’t’ know if Tarceva is a better drug than Iressa, or if Tarceva was merely the beneficiary of a better-designed clinical trial.

[randychub]

Master what happens to

osip survival rate p-value, if like irressa, long term survivors have a mutant egf'r. If you remove that subset of patients from the traveca trial, is the p-value still significant?

If those patients are the only patients treated with traveca, a market that would be shared by irressa, the number of patients taking this drug drops very significantly.

I posted this on the yahoo osip board also. I would appreciate any comments.

Thanks


Randy