regulatory
confidence high
sentiment positive
materiality 0.60
CEL-SCI files Breakthrough Medicine Designation with Saudi FDA for Multikine; signs MOU with Dallah Pharma
CEL SCI CORP
- Breakthrough Medicine Designation application filed with SFDA by Dallah Pharma for Multikine.
- MOU signed with Dallah Pharma for commercialization; final partnership expected Q3 2025.
- SFDA response time ~60 days; if granted, Multikine available for patient access and reimbursement in Saudi Arabia.
- Dallah Healthcare serves over 3 million patients annually via network of hospitals and clinics.
item 8.01