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Re: wmjenkins3938 post# 17489

Wednesday, 10/16/2013 8:24:09 PM

Wednesday, October 16, 2013 8:24:09 PM

Post# of 427816

They might be able to leverage a conditional approval with threats of a SPA lawsuit. What conditions?



The conditional approval I meant was that the FDA would pull the approval if REDUCE-IT failed, for instance.

"SPA lawsuit" is not going to happen. These guys have no recourse. Small foreign biotech? The FDA isn't the tiniest bit worried about repercussions here. They're a US government agency. There's no accountability.

The only leverage is how bad the FDA wants those REDUCE-IT results. If AMRN says, "We're stopping the trial, we can't pay for it." there's a tiny chance that would impact the FDA's viewpoint, IMO. They could care less about AMRN, fairness, or even the science on O3's, really. CYA is what this is all about.

“The trick is in what one emphasizes. We either make ourselves miserable, or we make ourselves happy. The amount of work is the same.” Carlos Castaneda

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