"Once we are able to have sales (FDA/EMA approval) for the primary use "any" patient within any of the parameters of diabetic cardio issues could be prescribed ABL."

Tada, I'm no doctor of medicine. But like you wrote, once approved for one indication or patient population, there is a lot of wiggle room in the gray area of expanding use to somewhat related indications and patient populations.

Vascepa could be an interesting example to follow. It was already approved for triglyceride lowering prior to REDUCE-IT readout. REDUCE-IT showed that Vascepa reduced MACE regardless of baseline triglyceride level or change in triglycerides. Amarin is in the midst of filing the supplemental NDA to expand the label. But since top-line data came out over five months ago, I bet a lot more off label prescriptions have been written for patients without elevated triglyceride but at risk for MACE. Plus, there are a lot of other potential indications that omega-3 fatty acids have been implicated in, so very likely some docs are prescribing for these suspected but not yet clinically proven benefit.

BearDownAZ