Replies to post #296984 on Amarin Corp Plc (AMRN)

[alm2]

HinduKush
Can you consider this ?
Alm

[jlucer53]

VASCEPA 2.0 MND-2119 is a drug delivery system play

Study ends august 2021. 4mg and 2mg self emulsifying drug delivery system. once a day dosing.

This appears to be the same molecule and is 52 week trial. Look on clinical trials website and per terra pharma

"$AMRN's partner Mochida updates their MND-2119 study today to announce completion of study June 29, 2019. Watch for readout in next month or so. Once per day dose, self-emulsifying, higher bioavailability. "

Question is

A) study is in japan so will FDA accept?

B) since its the same molecule if the FDA accepts a Japanese site study shouldnt they be able to get the reduce it label without a CVOT and just exclude Marine label?

C) not the same study population but if this the same molecule wouldnt they just need to show safety and pharmacokinetic and dynamic similarity ? its the same drug with a different delivery system. thats it.

this is just like when drug companies add extended release to extend the drug franchise.

Regulatory people is this not an option? Am i missing anything here??