gg No one is taking any HDL specific raising meds...or at least shouldn't be ...Niacin was a bust . In fact higher risk of stroke
My view ...Diabetics with HDL under 40 , TG over 200 and on Statin therapy are a higher risk population then non diabetics , with normal HDL levels but TG's over 200.
We want high risk patients in the RI to increase the chances of it being stopped at interim We also want to identify those groups of patients most likely to benefit from Vascepa
There are I believe up to 20m pre diabetic and diabetic patients in the US ...certainly a big enough market for Amarin. I think diabetics / pre diabetics are over 50% of those enrolled in RI ...poster James has better detail on that so I'll defer to him.
Enrolling lower risk patients at the start of RI enabled Amarin to quickly meet the FDA requirement for the trial being "substantually enrolled" so they could submit the NDA for Anchor ...but doing so reduces the chances of a stop at Interim JMO Kiwi