Hacker: I got the jest of what you were trying to say. Long term studies can lead to a lot of amendments but that does not mean consent has to be re-done every time. Its dependent on the amendment content.
If talking to the FDA leads to an amendment to say alter the statistical package, then that is not going to stimulate a change to the informed consent as that has no bearing on the conductance of the study specifically for the patient. But the site investigator would still have to go thru their IRB approval process. These outcome trials lead to many changes along the way simply because of their mass and the extended timeline---they suck to manage! The databases are just enormous!
JMO Epanova is junk! AMRN is sitting in the catbird seat post Reduce-It. Just going to need to stay patient!
Disclosure: Been adding several times to a an old cheap core held long under 20.00. Some of old shares sold at results. I have a nice pile now, but I don't think I am keeping up with Sharon though---LOL! I own too many bios--I spread the money around.
Just waiting around for the sNDA decision! Its not that far away.