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Re: sts66 post# 25174

Saturday, 02/08/2014 2:40:13 PM

Saturday, February 08, 2014 2:40:13 PM

Post# of 425845
When they submitted their application it was OK to list the intended endpoint (unproven) without fear of rejection yet over the last man years the FDA has taken a rash of failures that ave caused death for doing this... After-all: Amarins creed/motto/direction/intent is basically to help better Cardio-Vascular issues!

I can see the FDA backing away on drugs with certain risks YET the upheaval we are experiencing is we are talking about Fish Oil and one that is better and safer than any other form of it on planet earth!

It is taken everywhere and has virtually NO side effects.

Is Vascepa the Poster child for the FDA?

I truly think if they go for an extension of Marine only (modified Anchor) that is the best opportunity they have.

I do not think their intent was to get an OK to "treat CVE's" yet that added language certainly did not help their cause.

Derailed the train in full and now it is a runway.

The FDA will not approve Anchor as submitted yet if they accept the same "Exceptions" to the label as Marine, maybe the FDA will allow them to sell it (just as they allow Fibrates and Niacin)...

That last sentence makes my stomach sick when I think that we have a next to no side effect product that run circles around the others!

We should hire Larry King as our spokesperson!

John
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