Amarin Corp Plc (AMRN)

[ziploc_1]

Apparently the EMA is more concerned with bioequivilance than the U.S. FDA


"• A panel of the European Medicines Agency (EMA) said that Viatris (NASDAQ:VTRS) withdrew an application for a generic HIV therapy Raltegravir Viatris on Feb. 22.
• The EMA's Committee for Medicinal Products for Human Use (CHMP) said that based on review of data and the company's response to the agency's questions, at the time of the withdrawal, the regulator had some concerns.
• The EMA considered that BIOEQUIVILANCE with the reference drug was not shown as the study results showed differences in the absorption rate."


The FDA seems to have zero interest in the fact that the capsule of gV is less resistant to oxidation of the vital EPA than the Vascepa capsule...all of which makes gV less effective than Vascepa.