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Sunday, January 28, 2024 12:36:38 PM
They have a single trial where patients on SOC+L prior to progression did no better than those on SOC prior to progression. As measured both by the predefined primary endpoint of PFS but also by OS. That kind of creates doubt.
They changed to cross trial comps only years after knowing hat happened. The trial remained formally blinded to patient level data, but that does not mean they did not know the results of various analysis made using the unblinded data. We know as a fact that there was an efficacy IA i 2015, and anybody with a brain knows they were taking looks at the OS between the arms as the tail progressed hoping for the tail. And that makes the change post hoc.
The ECA they used was summary level data only which prevents it for being adjusted to patient level differences. Though there is some math that can be used, it is crude and the results have not even been disclosed.
The extend of resection issue is huge. The -L trial required intent for near total resection. ECA patients with near total resections lived as long as -L patients with near total resections.
95%? LMAO.
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