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Post# of 427008
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dmlcento

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dmlcento

Re: None

Monday, 10/14/2019 3:04:11 PM

Monday, October 14, 2019 3:04:11 PM

Post# of 427008
My question:

Dr. Hiatt,

I noticed that you were a part of the 2013 Vascepa AdCom. At that time you voted no to approval of Vascepa for those with trigs between 150 and 499. I am not sure if you have seen the results from the CVOT that Amarin was instructed to run. If you haven't, please see the link below. With these results in hand, if you were on the AdCom that is scheduled for Nov 14th, I would love to hear how would you vote to a question about expanding the label for Vascepa to mirror the trial's population. If you could let me know I would greatly appreciate it. Thanks in advance for your time and expertise.



https://professional.heart.org/idc/groups/ahamah-public/@wcm/@sop/@scon/documents/downloadable/ucm_502892.pd

His answer:

I am familiar with the published data but best not comment until after the FDA meeting

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