Biotech Values

[exwannabe]

ONTY: Clark or P3, do you guys know how the trial stop and patient "replacement" is being handled? The first SA article that started all this ad 2 different claims, and both seamed bogus to me.

Are you guys assuming that the extra patients are just to make up for the loss of power created by the known protocol violations, or are you also assuming that based on some rule patients have been removed from the ITT population? Also, were the peek points (and final N) adjusted?

On a related item, how many drop outs do you guys model at the trial stop?