Replies to post #192673 on Amarin Corp Plc (AMRN)

[mclim]

March 28th, FDA acknowledged they received the application. Today is day 55, and Sunday is day 60. Good luck to all of us!

March 28, 2019
BEDMINSTER, N.J., and DUBLIN, Ireland, March 28, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company focused on improving cardiovascular health, today announced that, as planned, it submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking an expanded indication for its lead product, Vascepa® (icosapent ethyl) capsules, based on the landmark REDUCE-IT™ cardiovascular outcomes study1, 2. As is typical, while the FDA acknowledged receipt of the sNDA submission, at this stage FDA has not yet communicated to Amarin the intended timing of its review. Unless and until the company learns otherwise in communications from the FDA, the review timing is typically communicated within 60 to 74 days of the FDA’s receipt of an sNDA. Amarin is operating under the assumption that the sNDA will be reviewed on a standard review clock of ten months resulting in a PDUFA date near the end of January 2020.

[Al4door]

Amazon indirectly has other drugs in the pipeline. If our main pill will work on many indications then it is infect many pills for different things i.e. equivalent to having many drugs in the pipeline. How come you can't see that FACT. It is going to happen, and you can take that to the bank. I rather have one drug that works on may indications than 5 different drugs made for 5 different indications that may or may not be safe, effective and easy os apple and produce. Amin just derisked the whole game. We won!