529, plan is 4 years for a Phase I study of 46 patients
From the FDA web site. Really, 4 years for a phase I study?
Estimated Enrollment: 46
Study Start Date: January 2012
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure
IMGN isn't testing safety on healthy subjects for ph1. Instead, IMGN went with subjects with relapsed NHL making recruitment difficult. They are probably hoping to see good activity in that patient group and advance the drug to phase 2/3 based on that.