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Re: jessellivermore post# 18624

Tuesday, 10/22/2013 10:07:38 AM

Tuesday, October 22, 2013 10:07:38 AM

Post# of 426487
Zum..

My guess is the FDA's lawyers are seeing the same logic fault in their position as I am..ie..the AdComm question skirts the terms of the SPA agreement and is irrelevant..The company does not need to prove the drug will work apriori...The FDA needs to prove it wont work..

Also the fact that trig lowering lowering drugs did not improve outcomes in two trials does not violate the SPA. There is a man load of "new scientific" evidence that trig lowering is only a rather trivial part of EPA's potential protective effects..The SPA does not specifically require proof of trig reduction importance..

":>) JL
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