The science changed. How clinicians see the importance of triglycerides in cardiometabolic disease and how to treat CVD/Obesity/Metabolic Syndrome and Diabetes is better understood now. That’s why the Reduce it trial is so rich with data. They do secondary analysis on it for a reason. Reduce it has those patients in spades. Plus, most of that patient cohort is also in registry data and treatment improves with data. Now think why they are doing research with the GLP 1 drug and it gets clearer. Their posters and presentation at the ACC build credibility.
The other thing that’s finally understood here is the mode of action MOA. In 2019 when FDA approved for CVD they still didn’t understand how this drug worked. Their posters creation of the mineral oil issue is as suspect as the patent loss by Du. Today, we understand the MOA much better and can apply it to curing cardiovascular disease. Turns out decades of statin use and following the food pyramid doesn’t cure CVD. I won’t get into how statins got approved and the data used but you can research it.
The problem here is that clinicians need new marching orders and standards of care. The days of physicians prescribing a Fenofibrate/Fibrate are coming to an end. The ADA (Diabetes) now includes Vascepa as a standard of Care. Practice of Medicine is the real issue to go with the new science. FDA does not regulate the POM which is why the label change is a big deal. It’s their final word on the matter and they didn’t issue a Dear Doctor Letter for a reason because it’s so obviously bad medicine. A Doctor that wants to practice medicine, wrongly prescribing a drug that offers no CVD benefit will have to answer to it. They can explain why. Good luck. If I was an attorney I’d have a new business.
Now you just need to get PBM’s on board and the next owner of this drug can start negotiating with PBM’s playing that coupon and tier placement game with a variety of drugs. Amarin has demonstrated they have zero leverage in this game. Since 2013 they tried to go it alone and the system beat them down at our expense. The end of this European disaster and the FDC are over by the last regime. Barclays can help plot an exit. So can a CSG. They already have a facebook group and a share count. Now we just crowdfund it like we all did with that attorney to get in front of judges a few years back Retail investors have more leverage at our disposal. In fact, Bob Burrows and I had a nice conversation about it.