Protalix BioTherapeutics, Inc.
Elfabrio
Fabry disease
Date
TBD
FDA decision · Date TBD estimated
What's at stake
An FDA complete response letter on Elfabrio for Fabry disease is in focus around Date TBD.
Primary source
· SEC 8-K
verified 15h ago
“The CHMP opinion is based on results from an open-label, switch-over study, BRIGHT (formally PB-102-F50), designed to assess the safety, efficacy, and pharmacokinetics (PK) of the new dosing regimen of pegunigalsidase alfa 2 mg/kg E4W for 5”