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Post# of 824026
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exwannabe

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exwannabe

Re: hoffmann6383 post# 591122

Friday, 05/05/2023 1:21:04 PM

Friday, May 05, 2023 1:21:04 PM

Post# of 824026
Making unplanned changes to the endpoints of a trial based on information from withing the trial is a basic no-no. At least the FDA and EMA say so.,

The changed endpoints were based on information from within the trial. Specifically that PFS had failed and that OS was confounded by heavy cross over.

That is a huge issue.
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