Baxter/Cerus predict US filing for blood safety technology:
This article was originally published in Clinica
A regulatory submission for Baxter International's and Cerus' collaborative pathogen inactivation system for platelets may be filed in the US in around 18 months time. So predicts Baxter, after it announced that the firms have agreed with the FDA to conduct a supplemental platelet transfusion study and perform additional analysis of its US phase III clinical trial data. The study is expected to provide additional data to address questions raised by the agency about platelet performance in the phase III study. The two steps are expected to be completed in the next 15-18 months, with a regulatory submission to follow shortly thereafter, says the Deerfield, Illinois firm. The technology is already approved in Europe.
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