Amarin Corp Plc (AMRN)

[bogatie]

3 biggest clues
I rarely post, although I've been here since 2013 and communicated significantly with the FDA and Congress after the ADCOM. My biggest gripe in all that fiasco was the presence of Dr William Hiatt on the ADCOM and his behavior. He had been paid by AstraZeneca in the years before ADCOM and AZ had just bought Omthera two months before the ADCOM (EPANOVA). Hiatt declared none of this on his statement to the FDA. He was very vocal about safety (no issues) and the design of REDUCE-IT. Which was totally irrelevant to that ADCOM. My biggest fear is that FDA will, in typical government fashion (I know, I have 30 years of federal government service), ignorantly allow such conflicted individuals to be involved in future decisions on Vascepa.

Anyway, my current thoughts are that there are three big clues, that when put together indicate very highly (90% or better) that AHA will be a blow-out:
1. On their website they have recently added a page showing the increase in CV deaths in US, despite statin usage going higher. (BB first noted this) No reason to post this unless they now know that Vascepa reduces CV death in a statistically significant manner. 2. listen again to CEO's comments on CNBC from 24 Sep (youtube) and he states that there is now a trial that shows reductions in deaths, MI, etc. He didn't say angina. He would not have said this, if they did not know that RRR on the key secondary endpoints were good and stat sig. 3. It has been exactly a month since Top-line read out and no secondary. Amarin could "cashed-in" with a secondary worrying that the stock price would be lower after AHA, and they have not done so. That is a very strong indication that they are confident that Market Cap will be higher after AHA. Their patience and these subtle hints are the signs that we are going much higher.
Best regards