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Posted On: 02/24/2021 3:55:04 PM
Post# of 155126
The MESO failure, as officially given in the PR, was due rising quality of SOC. They couldn't get enough numbers to hit stat sig.
I really believe in my gut that all deaths outside of 28 days are attributable to the placebo arm. To me LL works or it doesn't and doesn't work just enough to keep patients lingering in the hospital. And if we are allowed to include this data then the mortality endpoint would be crushed.
Let's look at this sample scenario. Patient A gets LL and recovers in 3 days and discharged after 1 week. Patient B is severe and gets placebo but progresses to critical and dies at day 30. Now if you looked only at the stats you will see that LL and placebo were the same, both patients survived past 28 days. But of course this is totally insane! So I believe we may have missed the PE due to circumstances explained above but the SE's should flesh all this out and that's why CYDY are having intense dicussions with the FDA.
I really believe in my gut that all deaths outside of 28 days are attributable to the placebo arm. To me LL works or it doesn't and doesn't work just enough to keep patients lingering in the hospital. And if we are allowed to include this data then the mortality endpoint would be crushed.
Let's look at this sample scenario. Patient A gets LL and recovers in 3 days and discharged after 1 week. Patient B is severe and gets placebo but progresses to critical and dies at day 30. Now if you looked only at the stats you will see that LL and placebo were the same, both patients survived past 28 days. But of course this is totally insane! So I believe we may have missed the PE due to circumstances explained above but the SE's should flesh all this out and that's why CYDY are having intense dicussions with the FDA.
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