Regulatory / FDA

FDA Status

FDA Center CBER
Application IND 33055
eCTD Sequence 0000
Submission Method ESG NextGen / Unified Submission Portal
Portal Status Submitted to Center
Product SanoMSC
Allogeneic Mesenchymal Bone Marrow Cell Therapy
Indication Ischemic Stroke with Persistent Neurologic Impairment

FDA Development Pathway

DuniyaBio Inc. is pursuing a formal FDA clinical development pathway for SanoMSC under CBER IND 33055. The submitted package includes:-

FDA Form 1571
RMAT Designation Request
Type B Meeting Request
CMC / manufacturing readiness materials
Supporting clinical/regulatory background documentation.