Amarin Corp Plc (AMRN)

[jfmcrr]

I let this get outa hand....

I expect that the safety profile of V is a given".

I believe that to be true, but I certainly would not expect the DMC to make that assumption.

Good Gawd man, they have to. The DSMB is charged with observing the progress of the study and intervening if something untoward and unexpected indicates that the study is harming the participants. It operates on the basis of feedback; the ongoing study produces data which confirms that the study is following the expected path or indicates that it is not. In Reduce It, events are the expected path.There is a projected rate and two groups rate. Events do NOT in and of themselves indicate V is causing harm. Only significantly (non parametric definition) more deaths/events than can be expected or markedly more than the placebo throw a flag. Then they intervene.


"the object of the exercise is proportion of events per group"

To know that you would have to start keeping track because on a quarterly basis, they are not going to be proportional. I would think on a quarterly basis, they only look at events in that quarter only. They are not keeping a scorecard.

Jeeze. This is a mess. Can you imagine that deaths/rashes/strokes/whatever pile up and the DSMB says,"We had no idea. We just looked at the quarterly numbers and never looked for a trend over time. Were we supposed ta?



"It is watching for an anomalous distribution of deaths among the expected deaths."

There would have to be a lot of assumptions baked in to do that. We can't even agree on a proper placebo rate on this board, but the DMC can figure it out by proportions? I just don't see it any other way than what I have previously stated.

Oh Well. Start with that the DSMB has the placebo/V group rates. In no way can they be restricted to a composite number