InvestorsHub Logo

mrmainstreet

08/16/17 11:48 AM

#112381 RE: Benny7459 #112361

Benny thanks for posting that comment from IR. Very interesting.

sts66

08/16/17 2:15 PM

#112394 RE: Benny7459 #112361

Given what we know about the safety profile of Vascepa and give our desire to capture a robust trial results, neither we nor FDA recommended adding a formal futility analysis to the interim looks in REDUCE-IT."



Wait a second - original R-IT SPA was formalized in 2011 or earlier - so if FDA believed there was no safety issue why the hell didn't they squash the comments from the ANCHOR Adcom panel about potential bleeding problems?!?