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Whalatane

04/29/13 4:36 PM

#5385 RE: Biobillionair #5384

To the best of my knowledge --- Reduce it more than 40% enrolled earlier this year ---run by PharmaNet/i3
AK

sts66

04/29/13 4:37 PM

#5387 RE: Biobillionair #5384

But your own post contained the 50% number:

"This application also contained a study report, but not the dataset, for the ANCHOR trial. This trial was not considered pivotal to the efficacy claims of Vascepa for this NDA. The ANCHOR trial investigated patients with TG between 200 mg/dL and 499 mg/dL despite statin therapy. The applicant was told prior to this NDA submission that data from the ANCHOR trial would not be mentioned in the Vascepa labeling until, at a minimum, 50% enrollment of a cardiovascular outcomes trial was reached."

If you have found something else that changes 50% to "subtantially", please do post it - makes no sense to me that we could start claiming ANCHOR indication before either the 50% number is reached or the sNDA is approved?