US Stem Cell Inc (USRM)

[NoMoDo]

Sponsors of drugs that have been granted accelerated approval have been required to conduct post-approval confirmatory studies to verify and describe the anticipated effects of their products on irreversible morbidity and mortality or other clinical benefit

From the FDA "Expedited Programs for Regenerative Medicine Therapies for Serious Conditions"

The whole guidelines can be found here:
https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM585414.pdf