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KCSVEN

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KCSVEN

Re: shadolane post# 207973

Sunday, 08/11/2019 3:43:11 PM

Sunday, August 11, 2019 3:43:11 PM

Post# of 425975
Last time it was because they did not have a study like RI as recent info at the time indicated improved lipid profile by itself did not mean drug would prevent heart issues, pretty easy call in hindsight, the change to the higher proof was last minute but was related to recent data so you can rationalize and understand why the last Adcom questions and results went the way they did, much different this time.
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