Amarin Corp Plc (AMRN)

[HDGabor]

raf-

„Premium” is a theoretical definition only. Premium is the difference between market valuation (Market Cap) and buyer valuation (BO value), so everything is possible. I fully agree w Ziploc_1: BO isn’t likely before R-IT result. If R-IT will be successful, the BO offer(s) will come in and the premium will depends on the market sentiment (before the offer).
Let’s say just for example, the BO offer will be $15B (and the share count will be 300M) resulted in $50 pps. If the Market Cap was
- $1,5B - > premium: 900%
- $3,0B - > premium: 400%
- $7,5B - > premium: 100%

Reduce-IT enrollment - John F. Thero / Q3 2014 CC

As we get closer to the end of the study, we're trying to make sure that we did the right patient mix. In all likelihood, events in the study, because it is an events-driven study, will probably come from the 7,000-plus patients who are already enrolled. And so whether we finish 1 month or different month probably won't have a huge impact on the timing of the trial being completed.

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mrmainstreet – “How solid is the 5.2% number”

I think it is very solid.

a.) HC Wainwright – March 12, 2015

Does this mean REDUCE-IT will suffer from a similarly grim fate? Our guess is no. Following discussion with the FDA, whose concern was exactly the problem illustrated in the graph above, the study increased by 1,000 new enrollees to allow for a downward adjustment of the placebo event rate from 5.9% to 5.2%. The same meta study above showed that the mean observed annual event rate across 29 diabetes outcome trials for just the core MACE endpoint for diabetics with baseline CVD was 5.19%, and as low as 1.42% without baseline CVD. After adjusting for the addition of coronary revascularization and hospitalization for unstable angina (the extended MACE endpoint used in REDUCE-IT), the observed placebo event rate went up to 5.64% in the ACCORD study, giving us reason to believe the anticipated 5.2% placebo event rate is likely to hold (NEJM 2010;362:1563-74). We find additional comfort in the telling silence of the independent DMC thus far (no news is good news at this point), and the company’s insistence that the data is tracking in line with projections.

b.) WO2014005013 A2 Patent

The current sample size calculation is based on an estimated placebo yearly event rate of 5.9% (23.6% over 4 years). To protect against the possibility that the actual placebo event rate is lower than estimated, an extra 1000 patients will be enrolled (approximately 7990 patients in total). By adding the extra 1000 patients, the event rate in the placebo group could be 5.2% per year (20.8% over 4 years) without having to modify the other sample size assumptions

The 5.2% isn’t the expected, it is the minimum for successful study (90% Power, 15% eff.), the real rate could be higher.

Best,
G