<<Is there a letter saying that "refractory is tough to call, and it is not necessary to make that call if a trial is placebo controlled and double blind".>>
Progressed after two, maybe three, chemo (including irinotecan) regime, with documentation. Is this difficult?
I continue to believe that other, also important data (other than confirmed refractory) are in play. Like: mortality, duration of response, survival, combined toxicity,....
Irinitecan is on *black* list (cardio and liver toxicity), so anti-EGFr may exuberate this toxicity (which is unknown).
IMO, until they clear all this issue on C225, market will stay on sideline.
However, I still can't understand that BMY was so desperate for new drug that got pulled into this mess.
Miljenko |