16 new lawsuits against isis seems to be a no brainer. Faruqi, Kronstein and Finklestein will draw blood.
So its up on first motion to dismiss. FDA has approved it with a given label. The law firms will shift to the label's warnings, arguing that this is what held it back. But it will have a license. So what is their remaining argument? EMA does not have to approve if FDA will. ISIS does not need EMA approval, the needy can come to the US. The very reasons the EMA did not approve have been addressed in the JPM Biotech transcript, just the other day. No more drop out issues remain. EMA will look dumb if FDA approves, so the pressure combined with ISIS having resolved the issues the EMA cited, will result in a turn around at the EMA. CASES DISMISSED...nice try, no cigar.