Replies to post #120626 on Biotech Values

[gdollasign]

What if the fda now says that they will not approve any cv drug without an outcomes study.

Is that something that you think is coming in the near term?

[investorgold2002]

buddy, AMARIN has said they will be able to use JELIS (18k patients , 5 years data) in support of SAFETY (yes and nothing more) data for AMR101 and FDA would accept it

SO THERE IS NO QUESTION ON SAFETY OF AMR101

[ronpopeil]

for a drug that yielded fantastic results and appears safer than a placebo? doubtful. of course with the fda you never know but i would make bets they won't.