Approval ProcessA key part of Capricor's thesis is based on extensive discussions with the FDA, and last steps toward approval could see potential hurdles.
Drug DevelopmentPotential hurdles remain for drug development, including the possibility of the FDA requiring additional data, potential manufacturing issues, and the need for an advisory committee meeting.
Regulatory ApprovalThere is uncertainty as deramiocel may not gain regulatory approval, and Nippon Shinyaku may not meet revenue forecasts.