Amarin Corp Plc (AMRN)

[AVII77]

in the end, Liraglutide won approval even though in North america the data sucked but they didn't get the primary prevention on the label/ Rather it is indicated for those with "established CVD". But again, the point estimate for this group was above 1 and our is below 1.

So, I'm replying to an old post of mine where I pretty much convinced myself the late ADCOM was primarily intended to explore the MO issue. After hearing Bhatt speak today (and reading the 10Q) my conviction on that has receded considerably.

And then today's SA article discussing primary vs secondary prevention population got me thinking. I still think it is a slam dunk that we get Primary prevention.

I don't know if anyone remembers Bhatt's tweet when asked about the results not being "SS" in women and he replied in a very civil manner something along the lines of "it would be a shame if this intervention were denied to women based on a faulty understanding of statistics".

Well it's the same story with primary and secondary prevention populations.

And it's the same story for LEADER's findings in the US population (below).

And LEADER was reviewed by the same ADCOM.

LEADER data didn't lead to a primary prevention label. But the difference between LEADER's PP data and R-IT's PP data is like night and day.

Anyway, I grabbed some forest plots from the papers and included them here as food for thought.