Thursday, October 17, 2013 4:13:01 PM
To eliminnate this line:
with mixed dyslipidemia and CHD or a CHD risk equivalent.
This line implies they are trying with this Submission to reduce Heart Attacks which is what the SPA is for...
If they said they were just trying to reduce Trigs like in the Marine Application maybe we would not be talking about why the FDA rejected them yesterday.
I think Vascepa went for a home run and failed.
Modify the application or ask for a change in an approval to the Trig reduction only in the 199 to 499 class.
Let the doctors then prescribe it off-label for those with Statins and CHD's...
with mixed dyslipidemia and CHD or a CHD risk equivalent.
This line implies they are trying with this Submission to reduce Heart Attacks which is what the SPA is for...
If they said they were just trying to reduce Trigs like in the Marine Application maybe we would not be talking about why the FDA rejected them yesterday.
I think Vascepa went for a home run and failed.
Modify the application or ask for a change in an approval to the Trig reduction only in the 199 to 499 class.
Let the doctors then prescribe it off-label for those with Statins and CHD's...
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