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Re: chas1232123 post# 54825

Tuesday, 07/28/2015 11:30:47 PM

Tuesday, July 28, 2015 11:30:47 PM

Post# of 424097
We agree that at this point it's a pretty safe bet that at least 50% of what happened to AMRN is due to FDA's stupidity/bureaucracy. The other 50% could be corruption or it could be all due to stupidity/bureaucracy.

We should find out about that the other 50% at the RI interim. If they will gladly approve RI without giving AMRN (if great results), it will show that they're government cronies, operating on simple stupidity. If they will continue to give us hell, even the least conspiratorial person here will have to believe that it's more than simple stupidity.

My question is do we go into RI interim empty-handed? Meaning, do we start a mother of all lawsuits against FDA and possibly drop it if they "behave properly"?

I would like to think that, as JL pointed out that we are where we are due to FDA's stupidity and they truly want to see RI results, because they are too stupid to draw conclusions without a CVOT. But if the FDA has another agenda, we will be in trouble regardless of RI results.
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