HD...
This is exactly my point..The FDA's questions do not have a direct bearing on the SPA agreement proviso which is that new science must show that Vascepa will not lower risk outcomes..
The only comparable study to REDUCE-IT is JELIS which is somewhat controversial, used a lower dose of EPA and treated a very healthy population with EPA/AA ratios much healthier than the one REDUCE-IT uses..JELIS did reduce CVD outcomes in several categories, some statistically significant, some not..As far as proving lower deaths from all causes, JELIS had less than 150 deaths in a population of 18,000 patients over a 4.5-5 year span..ie an annual mortality rate of less than 00.25% ...a figure precluding any conclusion of a statistical nature..
If the FDA is looking for tangential evidence regarding the SPA, it should be spending more time looking at JELIS and less time at fibrates and niacin. That of course assumes they are looking at this objectively..
I like AMRN's position here even though the FDA might very well break the SPA...Despite what the "Doves" on this board think IMO The FDA would be on very shaky grounds on this legally..and believe me the company will be going the legal route..
":>) JL
":>) JL
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