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Monday, March 25, 2019 10:23:24 PM
Based on the criteria for Priority review IMO the chance of V receiving a PR is very high...I would estimate in the 90% range..Not guaranteeing a PR; but my interpretation reading the FDA rules...V fits all of the criteria for a PR...The company should find out within a couple of months after filing the sNDA...
I do not think FDA will "hold a grudge" or has it in for Amarin...BB contacted Janet Woodcock...and she responded that she was aware of the seriousness of the RI result...(hint the PR is only indicated for serious medical conditions)
As an aside.. anyone who thinks Amarin falls into the category of being a " One Trick Pony" lacks a fundamental understanding of the potential of Vascepa. Because Vascepa effects one of the most important (likely the most important) systems controlling the rate of degeneration of the entire body. This means by the current way designating diseases by the location in the body that EPA may improve many different so called diseases...
Vascepa has the potential to effect every system and condition seen in aging...We have never seen a drug with this potential..The biggest single problem at present is that as well as lay persons, the medical profession is still ignorant of Vascepa's potential..Vascepa can be likened to stove used in cooking, and Vascepa can cook many different kinds of food...The human body is an enormously complicated system, which is chemical system...As such it must obey the laws of chemistry. EPA in therapeutic doses moderates inflammation...Inflammation increases temperature and raising temperature always increases the rate of chemical equations ( I also have a degree in Chem E.)
I like and have frequently used the analogy of cooking a roast in the oven..Turn up the temperature and the roast cooks faster..Aging is just slow roasting and increases of fractions of body temperature over the course of years has to have an effect on the rate of degeneration...
":>) JL
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