Replies to post #115451 on Amarin Corp Plc (AMRN)

[Biobillionair]

G-"efficacy should be proved also" There was a high degree of data pointing to the efficacy of Vascepa to prevent CVE. If a drug is ultra-safe it becomes a risk/reward medical decision that's should be left up to patients and physicians...something the pencil pushers at the FDA don't understand. Instead the FDA cancel an entire surrogate marker due to unrelated studies on different drugs not even studying the same biomarker. Very bad science.
BB

[Bolio98]

The bipolarity on the board is interesting: V isn't about TG lowering, more than TG lowering (e.g. inflammation) on one hand, but should be approved based on TG lowering on the other hand ...

The bipolarity on the board is not an Anchor issue. Has nothing to do with ANCHOR. If the FDA felt that lowering trigs in the 200-500 range was worthless then why accept NDA for ANCHOR? Why agree on an SPA? There was no credible science in the period after the SPA came out which would refute the clinical benefit of lowering trigs in the 200-500 class and allow the FDA the "out" they used.

I agree with zip 100%.

[centurycom]

So if they made a mistake in issuing the Anchor SPA why did they not eliminate the Marine indication? Science is science, right? That is why I believe the FDA was pressured by some entity and the science they used was faulty. They believed that Amarin would not challenge their decision as long as the Marine trial results were left alone. As it turns out that is exactly what happened. The carrot for Amarin was the RI trial which the FDA thought would reaffirm their decisions. That is why they set the bar so high. Instead it may well blow up in their face.