Koo asked "I am assuming we don't need a new drug application (NDA) filed in US to allow apabetalone to be commercialized outside of North America."

I can't answer that with much certainty. The European EMA approval will allow for marketing and commercialization is most, if not all of Europe. And the NDA approval will be necessary for marketing and commericalizatin in the US. However, off-hand I do not know the drug approval process for other countries/continents outside of the US and Europe. Does the NDA/EMA affect countries in Asia? Japan? Canada? Mexico? Austrailia? South America? etc? I'm pretty sure some countries follow the recommendations of the NDA, but I can't say which ones.

If any knowledgable posters know about this and can educate us, it would be much appreciated. 

BearDownAZ