Replies to post #99593 on Amarin Corp Plc (AMRN)

[Biobillionair]

Vu-
"Just my opinion"
I welcome everyones opinion, that's how we learn.

- I have no idea when 80% event will occur but guess around this month or next. Problem is that there are multiple moving parts that we cannot know. While we may know approx when 60% occurred (sometime last March) and when the company projects the 100% event (but they could be off by a month or two), we cannot know when 80% occurred or will occur.

That's why I built a model.

I don't think considering PYs from past CCs or presentations necessarily adds anything to ability to predict this.

Models aren't 100% accurate, there's estimates that have to be made. CC-8/K-10/K-and presentations have provided enough clues to estimate P/Y to within 500+/- IMO

The problem is that entry criteria changed to focus on patients who were at higher risk in year 3, which could make events occur faster over time. However, if V becomes more effective over time (which no one knows for sure), events could occur slower. If Pyr's hypothesis is correct regarding more drop outs in PL group (I would think this would be no more than 10% regardless), this would slow down the event rate as well, and delay the 80%.

Entry criteria has been melded into the trial by 5 years of exposure, it's now irrelevant. Had the entry trial rate been too low, the trial would not be completing in 2017. P's hypothesis is baseless and ridiculous. A higher placebo drop out rate is ludicrous. If it was placebo drop out the trial's final event would be pushed back. Because 80% is extended and the final event is not extended is an indication of efficacy.

For these reasons, I also don't think we can assume that a slower than anticipated 80% event necessarily indicates greater efficacy of V, although that would be most likely in my view.

If "V" was less efficacious or the placebo rate had a higher drop out 80% event rate can't be pushed back without pushing back the 100% estimate.

I also do not believe that info on PYs or when events occur tells us anything accurately about efficacy of V. To make that interpretation, we have to make assumptions about placebo rate, something we cannot know accurately.

I think we can estimate the placebo rate. That's what my model does.

Total events could be based on any combination of event rates across the two groups, so not terribly informative (much as I would like to be able to guess what the V rate is). Just my 2 cents on the large number of recent posts on these issues.

Can you PM me so I can get your email and send my model to you. Your'll get the detail model not the "drawing" sent to RAF.

BB

[rafunrafun]

"While we may know approx when 60% occurred (sometime last March) and when the company projects the 100% event (but they could be off by a month or two), we cannot know when 80% occurred or will occur."

My argument is that we DO know when the onset of 60% occurred, or at least when it was PR'ed to us - March 31, 2016. To stay on topic and not get sidetracked, let's only talk about the onsets of these interims (March 31, 2016), and not when the actual events (967, 1290, 1612) will occur.

I'm completely ignoring PYs, as we don't have enough info on them. Amarin said that the onset of 1612 will occur no later than EOY 2017. That is no more than 21 months for 968-1612. The question is: is 1290 the midway point (time-wise?

You say that entry criteria has changed in year 3. That is true, but IMO will not have much effect to differentiate the event rate in year 5 vs year 6. Perhaps year 2 vs year 6, but for the sake of argument we are only comparing years 5 and 6.

Based on the current available info, IMO we cannot assume anything other than what the company provided to us (tracking as expected and all the dates).

The only way I see that onset of 1290 NOT being the midway point is if the company is wanting to push it back slightly to allow few more events to occur, in case that they think it will be a close decision by DMC and those few events could make the difference.