CTI shuns FDA advice over new pixantrone trial
This article was originally published in Scrip
Cell Therapeutics (CTI) has gone against the US FDA's advice on the design of a new trial that it has just started for its lead chemotherapeutic, pixantrone, even though it hopes the study could serve as a follow-on pivotal trial if the agency remains firm on its April 2010 decision to reject the product's NDA for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL).
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