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Thursday, 06/09/2022 4:30:32 PM

Thursday, June 09, 2022 4:30:32 PM

Post# of 233111
Who here has seen the Statistical Analysis Plan for this trial?

Typically there is a section stating what is planned for Post-Hoc Analysis and how it will be handled. Who are we to say what is "allowed or not allowed"?

Everyone seems to forget how this whole 700/350mg was laid out....
https://www.businesswire.com/news/home/20220105005661/en/Leronlimab-14-Week-NASH-Clinical-Trial-Met-Primary-Endpoint-PDFF-and-Secondary-Endpoint-cT1-for-Per-Protocol-Population-in-350-mg-Weekly-Dose

The trial met its PE/SE six months ago!!! Now we know that 350mg is all you need to achieve similar results of 700mg !!!
Lower dosage of medications to achieve similar results are usually the preferred dosage.
(I could draw a comparison of laxative dosages...do you want to go there ???)


FOR CRYING OUT LOUD!!! THE TRIAL ENDED SIX MONTHS AGO !!! THE OPEN LABEL 350MG WAS NOT PART OF THE TRIAL !!!


A fair way to look at post-hoc analysis is:

Post hoc analyses are often conducted following primary result communication and publication of clinical trials, especially pivotal studies. They can be a way of better understanding the trial results and population, although caution should be used given the higher potential for bias and cherry-picking once the broader results are known.


http://www.rxference.com/post-hoc-analysis/

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