Sedana Medical announces positive FDA interaction
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has completed a successful End of phase II meeting with the US Food and Drug Administration (FDA). The FDA accepted Sedana Medical's proposals for phase III program, including study design and primary endpoints for the studies. This positive outcome means that the company can enter phase III in line with the communicated schedule.Sedana Medical is working to submit an IND during the fall and expects to receive an approval to conduct two randomized, controlled trials involving approximately 250 patients each, to