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zumantu

04/02/15 8:13 AM

#46568 RE: biowreck #46567

SPA Binding? Of course it's binding... on you, yes! but not on me

Here is how it works: you get to spend $150M and meet all requirements, and I get to change my mind ... that is how a SPA works - obviously

And after you pay your fees and I accept your sNDA, I can sit on it for 2 years... and there is nothing you can do about it... see how it works?

And when you file for NCE we can have an Ex- FDA attorney work as a front man stooge for us and file a "irrlevant" Citizens Petition asking us to name EPA as the active ingredient of Lovaza - 7 years after it was approved
and thus make it "complicated" and allow us to delay a NCE decision for a year and a half. Now that is cool, huh?

Are you getting it yet?




Whalatane

04/02/15 10:43 AM

#46579 RE: biowreck #46567

Biowreck ..

In agreements Amarin is binded to the terms set forth by the FDA .
FDA sets the terms ..Amarin either abides by them or not .
Their ( FDA ) terms gave them outs ...see HDGabors post.

If this was a contract .. there would be a clause for penality's if either party failed to perform

JMO
Kiwi