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Post# of 426493
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Williams4076

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Williams4076

Re: zumantu post# 53472

Friday, 07/10/2015 7:11:37 AM

Friday, July 10, 2015 7:11:37 AM

Post# of 426493
Zum-

This is the full instruction sheet for REDUCE-IT. It contains the steps the FDA has approved, which include Amarin to be notified of "safety" issues. FDA requested "safety" issues in the Anchor CRL. These safety issues could be actual events or some other random issue with drug or placebo; all CRF are analyzed by the sponsor in the protocol.

https://dl.dropboxusercontent.com/u/57678878/R-It%20patent%20%20app%20PCTUS1348559.pdf

This is a GREAT find!!!

BB
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