Jeffkad, the FDA:
- Knew the strength of the data leading into Reduce-it.
- The trial was guided by the FDA.
- The FDA certainly knows how robust the trial results are.
- 35% of the population at high risk for CVD already take some form of OTC fish oil. The FDA recently took a strong stance against DS products with the understanding, that such products, while perceived to be natural, will do more harm than good.
- Vascepa is in a class by itself in being natural, highest in purity, relatively inexpensive, and safe.
- I believe the board will be pleasantly surprised, as to how quickly things move once the sNDA is submitted.
ILT