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Message: Re: 2019 Potential Events
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Nov 27, 2018 12:02PM
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Dec 05, 2018 09:34PM

Iconoclast,

A couple previous posts for you.

Top-line vs. Full Detailed Results

Examples of top-line data

Usually top-line CVOT is just simple statement about hitting or missing primary endpoint. Usually no %RRR. However, Amarin/REDUCE-IT bucked that trend and announced %RRR for primary endpoint in the top-line announcement. There is a lot of data analysis to do. The data may not be able to be analyzed until the data set is locked, which might not occur until last patient follow up visit. Safety follow ups are 4 to 16 weeks after dosing ends according to the company BETonMACE trial design slides and posters. I asked Resverlogix for clarification on this last week but more or less was brushed off. Top-line may only refer to primary endpoint. Even when data analysis is done, they may wait to present full data until scientific meeting. They may present pre-specified subgroup analyses for the primary endpoint at a later date. They may also reserve cognition and renal sub studies for other meetings. I expect data analysis and presentations to occur throughout 2019. Top-line will not contain all data.

BearDownAZ

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