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BioChica

10/24/13 12:08 PM

#18985 RE: zumantu #18983

I think that there was enough evidence at ADCOM to dispel the the failed Niacin Fibrate trials. The FDA Panel chose to ignor them. The FDA, intent to break SPA was clear at the ADCOM! The only way out of this is by legal means now. But this may mean waiting until December 20 or they need to have another ADCOM.
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HDGabor

10/24/13 12:10 PM

#18987 RE: zumantu #18983

"FACTS SPA is broken" - not yet. SPA is between AMRN and FDA (not with AdCom)