Sorry if this has been posted before, but just saw it on YMB, and think you all need a dose of it (BTW, I am not Ted):
Quote:Ted yesterday
A few of the tried-and-true douches are here, spending their precious weekend spreading fear and venom. There has been speculation ad nauseum about the cd12 mortality rate, all based on variables that none of us truly knows. Here are a few things that we do know, however.
1. Humanigen's lenzilumab, despite getting a lot of press (and government attention), does not have an ICD code. Isn't that interesting?
2. The lenzilumab trial was forced to increase its trail size after a DSMC review. Subsequently, it had to change its primary endpoint. The leronlimab trial had two DSMC look-ins. Enrollment was unchanged. Primary endpoint (mortality) was unchanged. In other words, one drug has been on track to meet its goal of safety and efficacy without alteration.
3. After the CD12 trial was fully enrolled, the FDA reinstated use of eINDs for leronlimab (the agency had suspended it in an effort to help enroll the trail faster).
4. The FDA then went a step further and granted open label extension, meaning that patients at the clinical trial sites are now all receiving leronlimab. Given that the FDA's primary purpose is to protect the public from unsafe drugs, why would the agency greenlight leronlimab for open label use unless it was perceived as safe and effective?
5. There are now three peer-reviewed papers (Yang, Agresti, Patterson) affirming leronlimab's mechanism of action against covid. Even if you throw out everything else as speculative, there is nothing speculative about being published in a peer-reviewed journal. It's unassailable evidence that the drug is working, validated by the scientific community.
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