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Replies to post #720 on Oxford BioMedica PLC (OXBDF)
georgejjl
02/12/19 8:12 PM
#721 RE: georgejjl #720
FDA confirmed that studies previously conducted using first generation ProSavin® may be considered part of a single development program with AXO-Lenti-PD, including the preclinical data and over 10 years of clinical data of ProSavin. The FDA also provided feedback on the design of the SUNRISE-PD phase 2 study of AXO-Lenti-PD and agreed that current manufacturing and quality control plans were adequate for the clinical program.