Pfizer has announced on 28 April 2022 they have received approvals to re-start the Phase 3 study evaluating their gene therapy for Duchenne muscular dystrophy in several countries, including the UK, and that the clinical hold in the US has been lifted by the FDA.
Following the lift of the clinical hold, Pfizer is now proceeding with the study in the UK, and working to activate trial sites to begin recruitment, screening, and enrolment in their Phase 3 ambulatory trial (CIFFREO) for the first time.
Coinciding with the press statement, Pfizer has produced a letter to the community.
Interesting further information
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