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Message: Re: FDA
FDA
8
Sep 30, 2019 01:54PM
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Sep 30, 2019 02:11PM
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Sep 30, 2019 02:19PM
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Sep 30, 2019 03:03PM
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Oct 01, 2019 12:28AM

https://www.nejm.org/doi/full/10.1056/NEJMoa1601747

Betrixaban (Portola) is one example that I know of that missed the primary endpoint in cohort 1 (narrowly).  The subsequent analyses were considered exploratory and were significant.  The drug still was approved on the basis of this trial.  

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