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Re: Chabojilo post# 19664

Wednesday, 10/30/2013 12:53:04 AM

Wednesday, October 30, 2013 12:53:04 AM

Post# of 426915
Chabojilo - You hit it on the head!

I called Amarin today around noon and asked Joe Bruno why the "CVE" and "Risk Group of people on Statins" was added to the Anchor app... He said it is normal to add the target group you are treating to the application...

WELL: They did not do that in the Marine Application YET were smart enough to write the following in the (Marine) application:

1. "Vascepa is not proven to reduce Inflammation in the Pancreas."

2. "Vascepa is not proven to reduce Cardio Vascular Events."

BINGO!!!

It was approved!

NOW: Lets go back and modify the Anchor App to say the very same thing in treating the 199 to 499 class!

I've been saying this since the AdCom Board rejection!

Focus on what the FDA is saying while looking back on what they approved!!!

Seems to easy to me...

Learn from the mistakes to change the future!
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