RMB, IMO the new formulation will conquer these issues in a few ways...
1. Lower cost - half the API, so they can afford to keep the price lower to patients.
2. More effective - goes without saying
3. Will be for the CVD indication only
4. Amarin may launch AG when they launch the new formulation, under the MARINE indication only. And they can undercut the other generics on price, because they are not as concerned about making huge margins on that indication, thus pushing out the other generics from the market.
5. By having the new formulation for CVD indication, and an AG for the MARINE indication, there should be no "confusion" about what is being prescribed for which indication.
Obviously this is all theoretical at this point, but it's how I believe they will position themselves to regain the US market. I don't believe they are hanging their entire future on the outcome of a trial. Although a positive outcome will simply be icing on the cake (will further dissuade generics and insurers from infringing). Not to mention a potential pile of cash.