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Re: None

Tuesday, 11/12/2019 10:12:24 AM

Tuesday, November 12, 2019 10:12:24 AM

Post# of 425847
Kiwi, tell me this wasn't close,

4. VOTE: Has the applicant provided sufficient evidence of efficacy and safety to support the
approval of Vascepa for an indication to reduce the risk of cardiovascular events?
a. If yes, provide your recommendations regarding the indicated population and
components of the primary endpoint to include in labeling.
b. If no, provide your rationale and comment on what additional data would be needed to
support approval.



Source: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=152220564

My prediction,

"Do the efficacy and safety data from the REDUCE-IT trial provide substantial evidence to support approval of a claim that adding icosapent ethyl to statin therapy reduces the risk of cardiovascular events in patients with diabetes mellitus and at least one additional risk factor?" (PROPOSED)



Source: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=152195685

Although, I will admit, I didn't think Amarin had the cajones to say, "fuck it, everybody gets vascepa!"
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