Thursday, May 08, 2014 12:07:35 AM
They did not ask for it YET the basic premise of Vascepa was and always has been an ultimate reduction in CVE's which is basically their Company credo... They noted the letters CVE in their application.
This has always been why the FDA has put the brakes on Vascepa...
Once Vascepa proves a reduction in CVE's, the FDA will approved it...
I spoke to Joe Bruno the week after they lost their fight back in October asking him why they had the letters CVE in their application and his reply was: You generally always put your goal in your application.
I asked him if they would request an extension of the Marine Label approving treatment of those with High Trigs now that they failed with Anchor and he said YES...
Meaning go back and modify the application removing any CVE language, lettering, or whatever you care to call it and just go for what we all thought they were going for and that was always JUST AN EXTENSION OF THE MARINE LABEL...
Unfortunately the FDA decided to demand proof because of so many other failures and bad publicity over the last many years including Fibrates and Niacin.
No one from the FDA ever said Amarin and Vascepa will not work - they just said prove it...
See you again in 2016!
Long 17k shares at 13.00 per share!
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