mercurius-adept schreef op 19 november 2020 17:38:
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“We believe that etranacogene dezaparvovec has the potential to be a first- and best-in-class gene therapy for patients with hemophilia B,” stated Matt Kapusta, chief executive officer of uniQure. “We are very pleased to have met the 26-week FIX primary endpoint and to feature these promising data at the upcoming ASH conference. Based on interactions with the FDA and EMA, we plan to incorporate FIX activity and bleeding rates at 52 weeks as additional co-primary endpoints in the study. We look forward to holding our pre-BLA meeting with the FDA and completing the last patient’s 52-week follow-up visit in the first quarter of 2021.”
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