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Full notification Final report - General information Notification Number B/DE/22/PEI4988 Member State to which the notification was sent Germany Date of acknowledgement from the Member State Competent Authority 29/07/2022 Title of the Project Clinical Study J3Z-MC-OJAE: An Open-label, Dose-Finding, Phase 1/2 Study to Evaluate the Safety and Tolerability of a Single Intravenous Dose of LY3884961 in Patients with Peripheral Manifestations of Gaucher Disease. Proposed period of release: 01/07/2022 to 30/09/2024 Name of the Institute(s) or Company(ies) Prevail Therapeutics, Inc., 430 East 29th Street, Suite 1520 New York, NY 10016 USA.
Is the same GMO been notified elsewhere by the same notifier? Yes:
Germany; Spain;
Has the same GMO been notified elsewhere by the same notifier? No GMO characterization GMO is a: DNA Virus Identity of the GMO: Genus: Dependoparvovirus Species: Recombinant AAV9 Information relating to the recipient or parental organisms from which the GMO is derived Common Name: N/A Genus: Dependoparvovirus Species: Adeno-associated virus Subspecies: N/A Strain: AAV9 Pathovar: European Commission administrative Information Consent given by the Member State Competent Authority: Not known
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