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IgnoranceIsBliss

10/16/13 9:03 PM

#17500 RE: wmjenkins3938 #17497

But even at that the FDA doesn't want other drug companies to think renege and not want to enter into a SPA.



What are other companies going to do instead? No SPA? Stamp their feet? Post nasty messages on iHub?

It's all a game, and the house sets all the rules. It's not about fairness. It's about crafty navigation. And there's certainly a lot of luck involved about developments post-SPA.

Barring a miracle, the FDA will convince itself that the "science" really did change, that they were totally justified, and that anyone who disagrees is evil.

And all of AMRN's competitors will nod and smile while the FDA says all this. Because they know there's no upside in pointing at the elephant, and all they want to do is ingratiate themselves, because they don't want to be the next AMRN.

In a nutshell: It is simply not a fair fight.