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Sophiris Bio Receives Positive Feedback From European Medicines Agency Regarding Phase 3 Localized Prostate Cancer Clinical Trial Design


Wednesday, 19 Jun 2019 08:30am EDT 

June 19 (Reuters) - Sophiris Bio Inc ::SOPHIRIS BIO RECEIVES POSITIVE FEEDBACK FROM EUROPEAN MEDICINES AGENCY REGARDING PHASE 3 LOCALIZED PROSTATE CANCER CLINICAL TRIAL DESIGN.SOPHIRIS BIO INC - PHASE 3 STUDY DESIGN, AGREED UPON BY EMA, WILL ENROLL PATIENTS WITH A CONFIRMED DIAGNOSIS OF INTERMEDIATE RISK DISEASE..SOPHIRIS BIO - BELIEVE THAT DATA FROM A SINGLE PHASE 3 TRIAL, IF SUCCESSFUL, WILL BE SUFFICIENT TO SUPPORT MARKET APPROVAL IN EUROPE.