Nice analysis Chas - thanks. R-It would predict that STRENGTH will likely show statistically significant benefits, but somewhat less than R-It. If Epanova is approved, it will not be until approx August of 2021 at the earliest (assuming priority review), based on latest study end date of Sept 2020. Might come down to an issue of marketing differentiation and price between V and epanova when 2022 rolls around.
If I recall correctly STRENGTH duration was expected to be 3.5 years but they may be running a bit long, so let’s call it 3.7 years.
Actually, the trial was extended by a full year, pushed out from H2/19 to H2/20 - how does that affect your numbers?
Some of us have asked a question that has gone unanswered - how did the trial get an extra year added when it's an event driven trial? Is event rate slower than expected or are they going over the planned # of events, and if the latter is true, is it ethical? If it's the former, given that these are higher risk patients than R-IT recruited, does that point to E having better efficacy than what people expect?
Even if they have good or great numbers, for now AMRN IP has blocked them from marketing E in the US - wonder how good results have to be for AZN to pull out all the stops and go full bore in court trying to overturn the IP protection?
Quote: "To give a best case estimate (for Epanova, worst case from Amarin’s perspective), ignore the likely LDL-C increase from the DHA and any negative effects of extra material and assume DHA has 1/3 the benefit of EPA (due to good trig reduction benefit but lacking many other benefits of EPA).."
DHA does not have 1/3 the benefit of EPA...That is nonsense. Trig lowering in no way connotes. CVD event RRR... Elevated trigs are a surrogate for elevated Systemic Inflammation and lowering trigs only lowers CVD event risk if the lowering is caused by lowering SI And lowering trigs only lowers CVD event RRR if it is accomplished by lowering SI..EPA lowers SI..DHA has none of that effect..That is because EPA can interact with the COX and LOX cell membrane receptors which have a profound effect on SI and DHA can not...
DHA does lower trigs (in a non beneficial way) because it also raises LDL-C levels..but does not lower SI.
I suggest you confine your opinions to topics you know something about..
Acting like an expert which you clearly are not only raises the confusion level on the board...I would guess the benefit in strength would be around 6-7%...but that is just a guess...