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raistthemage

08/09/19 5:23 AM

#207056 RE: Bolio98 #207051

This is an interesting idea...

AMRN unilaterally changing the label and claiming the label based on the Reduce-It results is truthful and non-misleading information. Its nuclear and risky and a last resort following a CRL but I like it... if the FDA conducts itself badly enough and say overrules their own ad-com I think it will holdup in court. Best to keep it in reserve until then.