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Monday, September 12, 2016 11:34:05 AM
We are painfully short on information. So far the market seems to be taking the situation a lot more calmly than I would have anticipated...Though the nite is young and there may be some propping up of the market as some of the big guys get their visas stamped.
There are two mitigating factors here that I can see...First the wait until the 80% interim is not so far away as this first interim has gobbled up 6 months..The second is the important difference between the mixed dyslipidemia indication and the T2DM indication...mixed dyslipidemia is to a certain degree a lifestyle...They eat too much...of the wrong foods, do not have healthy habits such as exercise...and are less likely to go to doctors or follow the doctors instructions..Most adults understand being overweight is not only a health hazard, it is understood it makes you look less attractive, or socially desirable.
T2 diabetics include dyslipidemics, but they are more use to taking medication, because their condition requires it..Compliance is a huge problem for clinicians..The old saying is.."The patient will take the pills until the pain stops"..So its just easier for T2DMs to take Vascepa as part of their routine than for dyslipidemics who to a certain degree are where they are because they are non compliant..
So IMO Amarin understands that the secondry and tertiary endpoints regarding V's effacy on T2s is very important. We estimate about 70% of R-I enrollees are t2s...This is less than 100%...Making sure the T2 data is robust is essential and may explain the extension to 80% or till trial end..
":>) JL
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