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Notification report


Full notification file


General information

Notification Number
B/ES/20/17

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
22/09/2020

Title of the Project
A Phase 1/2 Ascending Dose Study to Evaluate the Safety and Effects on Progranulin Levels of PR006 in Patients with Fronto-Temporal Dementia with Progranulin Mutations (FTD-GRN).

Proposed period of release:
01/03/2021 to 30/09/2027

Name of the Institute(s) or Company(ies)
Prevail Therapeutics, Inc., 430 East 29th Street, Suite 1520
New York, NY 10016
USA.;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Belgium; France;

Has the same GMO been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):


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 wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
-DependoparvovirusAdeno-associated Virus-AAV9-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known