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

Duniya SanoStem 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.