Sedana Medical informs about adjusted US submission plan following FDA interaction
Sedana Medical AB (publ) today informs that the US Food and Drug Administration (FDA) has requested the company to include long-term outcomes data in the Clinical Study Report (CSR) of the INSPIRE-ICU trials before the New Drug Application (NDA) can be submitted. This is expected to move the filing date by approximately one year to Q1 2025, but is not expected to materially impact the overall cost for the clinical program.INSPIRE-ICU 1&2 are two identical phase III studies to confirm the efficacy and safety of inhaled isoflurane delivered via Sedaconda ACD, compared to IV propofol, for