<<I don't understand any focus on formal responses. IMO ttp is the rational measure for any molecule, but it has to be the hurdle for new cytostatic agents.>>
Objective response is indicator that sub-group of the pts benefit more than average ones, and that there may be long term survival benefit. It is hard to follow survival beyond 18 months from randomization, as there are many factors that can paint picture one way or another, that has to be took into account. So, TTP is as good as it can be, but it is not definitive answer. All combined (RR, TTP and OS) need to be on positive side to demonstrate drug medical benefit, imo. (Velcade in APET as example)
<<Don't remember the role of clinical investigators in reporting Maxim data, if there was one, but..... which would you prefer?.... a company that respects the investigator or one that digests the data for you?>>
None of them. Nor investigator, nor company report full story. Only publication (with reputation) can be taken seriously, until FDA permit as to look on whole NDA package before AC (at least clinical part, which should not be a problem).
Miljenko
PS: Good luck with ONXX |
