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Posted On: 02/24/2021 3:07:37 PM
Post# of 148872
Since the DMSC came out with the recommendation to look 42 day mortality I've always thought they are seeing a significant number of deaths after 28 days. Why would they suggest it if they didn't think it was meaningful?
The ability of modern medicine to keep very sick people alive longer may cause us to miss our PE but given we are in a pandemic I don't think we will be denied an EUA if the 42 day data is good. Or even the 60 day data. That 60 days is being mentioned in FDA trial guidelines is very reassuring to me.
When I was figuring out numbers for Tech Gurus poll I figured 82 deaths at 28 days (36 in the LL arm, 46 placebo). For the 42 day totals I added an additional 10 deaths, 2 LL, 8 placebo, for my final numbers of 38 LL, 54 placebo. Probably a little optimistic, but from my notes mytwocentz and Rex 47 had similar numbers. And of course Goosebumps was off the charts.
From the numbers that Tech Guru and Borel provided, its pretty clear that a handful of deaths (god rest their souls) either way could make a real difference in terms of statistical significance. But to repeat--if we miss our PE at 28 days I gotta believe clinical significance will get us our EUA. Because its a freakin PANDEMIC! And because the new administration is looking for something--anything--to help take death off the table. Even if it comes from a tiny biotech with no approved drugs or lobbyists.
Don't get me wrong--I'm actually still holding out for stat significance at 28 days. But I don't have any background in science or medicine to justify my conclusions... just careful and voluminous reading. (With many of the relevant sources coming from folks on this board; thank you!).
But given that... the optimist in me says we have it both ways--barely stat significance at 28 days, and crushing it at 42. Cause I like to have my pie and eat it, too.
And the discussions are all about logistics and vials and manufacturing and how to divvy up one life-saving, extremely valuable, pie.
The ability of modern medicine to keep very sick people alive longer may cause us to miss our PE but given we are in a pandemic I don't think we will be denied an EUA if the 42 day data is good. Or even the 60 day data. That 60 days is being mentioned in FDA trial guidelines is very reassuring to me.
When I was figuring out numbers for Tech Gurus poll I figured 82 deaths at 28 days (36 in the LL arm, 46 placebo). For the 42 day totals I added an additional 10 deaths, 2 LL, 8 placebo, for my final numbers of 38 LL, 54 placebo. Probably a little optimistic, but from my notes mytwocentz and Rex 47 had similar numbers. And of course Goosebumps was off the charts.
From the numbers that Tech Guru and Borel provided, its pretty clear that a handful of deaths (god rest their souls) either way could make a real difference in terms of statistical significance. But to repeat--if we miss our PE at 28 days I gotta believe clinical significance will get us our EUA. Because its a freakin PANDEMIC! And because the new administration is looking for something--anything--to help take death off the table. Even if it comes from a tiny biotech with no approved drugs or lobbyists.
Don't get me wrong--I'm actually still holding out for stat significance at 28 days. But I don't have any background in science or medicine to justify my conclusions... just careful and voluminous reading. (With many of the relevant sources coming from folks on this board; thank you!).
But given that... the optimist in me says we have it both ways--barely stat significance at 28 days, and crushing it at 42. Cause I like to have my pie and eat it, too.
And the discussions are all about logistics and vials and manufacturing and how to divvy up one life-saving, extremely valuable, pie.
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