European Orphan Drug Designation (“ODD”) qualifies NXC-201 for:
- 10 years of market exclusivity once authorized in the EU
- Access to the EU centralized authorization procedure
- Reduced fees for EU protocol assistance, marketing authorization applications, inspections before authorization, applications for changes to marketing authorizations made after approval, and reduced annual fees
“European Union orphan drug designation for NXC-201 represents an important milestone in our global strategy,” said
Orphan drug designation in the
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Company Contact
irteam@immixbio.com
Source:
2024 GlobeNewswire, Inc., source