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Tuesday, 06/23/2015 7:43:52 PM

Tuesday, June 23, 2015 7:43:52 PM

Post# of 427872
Could the FDA have possibly have made a stronger more admission of their intent to coerce Amarin into completing REDUCE-IT ? Further, FDA did so with full knowledge that Amarin and it's shareholders would necessarily have to bear the extraordinary expense of funding the trial for to not do so would be tantamount to signing their own death warrant.


From Woodcock's statement:

"If Amarin were permitted to make effectiveness claims supported only by credible evidence, such as the heart disease claim on dietary supplement labels, in conjunction with its continuing distribution ofVascepa, the incentives to conduct the REDUCE-IT trial would be significantly reduced. Although I understand that Amarin has stated that it intends to complete the REDUCE-IT trial, it is conceivable that Amarin might choose to forego the trial should it prevail in this lawsuit. Were that to happen, the medical and scientific community would be deprived of the robust scientific data promised by the REDUCE-IT trial regarding the safety and efficacy of Vascepa for the use related to cardiovascular disease."

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