Amarin Corp Plc (AMRN)

[jessellivermore]

Double blind studies DBSes

DBSes are excellent at concealing information from the treating physicians and the patients. They are far less effective of concealing information from groups like the DMC or the drug company involved. It is fairly simple to deduce what is going on in the trial. All they really need is the total number of events occurring over time. From this point using logic and arithmetic it is easy to determine how well the drug is working.

REDUCE-IT is a DBS.

How the effectiveness can be determined.

Assuming the drug is safe.. the information everyone's looking for is how effective the drug is at lowering risk.To determine the drug's effectiveness you do not need to have the exact risk rate in the placebo group. What you must know is the lowest percentage the placebo risk rate can possibly be. That is to insure that you are not attributing a lower than expected number of events to the effect of the drug; when the real cause is there was not as much risk as estimated. So getting the placebo risk rate is the first key. This is done by looking at the first six to nine months of the trial and measuring the event rate. Studies like JELIS show that in the very early portion of the outcomes trial the risk of the placebo arm and the active arm are fairly close. Over a period of a year and a half the event rate of the two arms will diverge on a line graft as the risk rates begin separate.

If you take the total events in the entire trial over the first 6-9 months, that will give you a fairly accurate estimate of the risk in the untreated group. Fairly accurate because both arms will be fairly similar. Actually the real risk in the placebo will be somewhat higher than your estimate because the treated group will be lower. This OK because it means you are not going to overestimate the risk lowering of your drug.

From that point, you simply apply your determined placebo rate to calculate the events predicted if the entire trial was placebo and compare the calculated number to the events measured from the trial itself (the data)...Since half the trial is placebo and half Vascepa if data shows the actual measured number of events is 20% under the all placebo estimate, then the Vascepa rate reduction is 40%. It is twice the measure percent.

Currently the company, according to the EPAI statman the company is looking at between 25% to 32% reduction of events which calculates out to a 50%-65% reduction in CVD events...This is even at the wonderful LDL-C levels AKANZ is so proud of...

":>) JL