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?