May 10, 2018 / 5:25 AM / 6 months ago

BRIEF-Rovi Updates Status Of The Pivotal PRISMA-3 Study Of DORIA

May 10 (Reuters) - LABORATORIOS FARMACEUTICOS ROVI SA :

* SAID ON WEDNESDAY THAT AN INDEPENDENT DATA MONITORING COMMITTEE HAS RECOMMENDED TO CONTINUE THE CLINICAL TRIAL OF PRISMA-3 STUDY FOR THE ONCE-MONTHLY INJECTABLE FORMULATION OF RISPERIDONE ISM, DORIA, TO TREAT SCHIZOPHRENIA

* RECOMMENDATION ALSO SAYS THAT AN INCREASE OF THE STUDY SAMPLE SIZE IS NOT NEEDED

* COMPANY PLANS TO FILE A NEW DRUG APPLICATION (NDA), U.S. REGISTRATION DOSSIER FOR THE FOOD AND DRUG ADMINISTRATION (FDA) IN SECOND HALF OF 2019

Source text for Eikon:

Further company coverage: (Gdynia Newsroom)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below