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Re: williamssc post# 480847

Saturday, 01/18/2025 11:07:59 AM

Saturday, January 18, 2025 11:07:59 AM

Post# of 511152
Drugs/Treatments get approved based on risk versus benefit. The MABs risk/benefit ratio is not great, but at the time of approval was the best available on solid data and statistics. The "there was no brain bleed" argument can't stand as reason for approval, the benefit has to be shown to be real too.

The issue I see is that we have a trial that failed its to protocol endpoints, but is balanced towards likely benefit by a combination of the multiplicity rule replacing the co-primary endpoints with one secondary and one primary endpoint. Then two years later additionally a partial (Australian only) 144 weeks placebo late drug starter vs. early starter RCT drug starters result comparison. It make no sense to not present that as a chart, unless this statement:

Treatment LS mean difference continued to increase up to week 192


Is not describing a linear function and the company wants to hide that.

The longer we wait, the sooner we will get rich!

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