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Sunday, February 09, 2014 1:36:29 AM
The FDA did not say that Reducing Trig's will not reduce CVE's...
All they said is there is no current test that they can (or will accept) that shows a reduction in Trig's reduce's CVE's...
They said the Fibrate and Niacin studies did not prove a reduction in CVE's... They are 100% correct yet (let me finish...):
LISTEN to what I am about to say closely: They basically said that the Fibrate and Niacin tests did not show a reduction in CVE's meaning (what they should have said is) they are bad tests for the endpoint that Vascepa is shooting for...
We all keep arguing that those tests cannot be used against Vascepa. They are NOT being used against Vascepa. They are not even in the same class of testing that Reduce-It is going to prove... It is like saying reducing weight will help reduce heart attacks yet the people in the tests were already in the OK weight class so we have no proof... I wholly agree with that statement and position!
What the FDA should have said was the two tests did not meet the same level of testing that Reduce It is undergoing nor can we (we being the FDA and Amarin) use the two tests to support or deny that Reducing Trig's will help reduce CVE's...
No one on this board has ever said: "The FDA should have allowed the tests because they did show what we are looking for..."
We all agree - Investment community and the FDA that the two tests were useless for helping Vascepa's cause!
We all agree with the 99% of the Dr's who say reducing Trig's is a must.
To cut right to the chase: I long for the end of the Reduce-It trial knowing the Medical Community will have proof that the Reduction in Trig's will help reduce CVE's...
Reduce It will be the 2nd (Jellis being the first) and the only US approved test to show a reduction in Trig's will show a proven reduction in CVE's.
The longs who can lose or live without the investment money are feeling good inside and can sleep at night including myself.
Those who wanted a short term check or those who do not believe in the science are feeling their oats right now.
I am a major believer in the science...
I'll will resort to my fall back comfort: As Warren Buffet once said - "Consider an investment a 10 year plan and only invest money you do not need during the same period"... (In more or less words.)
Sit back and look forward to 2018 (or hopefully sooner!)
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