LifeCycle Pharma Receives Special Protocol Assessment (SPA) From FDA for LCP-Tacro(TM) Pivotal Phase 3 Study in De Novo Kidney Transplant Patients
Globe Newswire -- LifeCycle Pharma A/S (Copenhagen:LCP) today announced receipt of agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) of its pivotal Phase 3 study, Study 3002, for LCP-Tacro(TM) in patients, who have just received a kidney transplant ("de novo" transplant patients).