Ohm20, Just to reaffirm, the smaller the observ
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Posted On: 06/21/2021 12:31:42 PM
Ohm20,
Just to reaffirm, the smaller the observed clinical impact, the larger the trials needed to achieve statistical significance.
Clinical significance (does the patient benefit meaningfully) is a separate but related issue to statistical significance (are the results real/very unlikely to be due to chance),
Had CD12 critical intubated sub population Beeman standalone trial, it’s very marked clinical impact (82% days 14, still 24% at day 28/3 weeks after last dosing) would have achieved statistical significance with only 62 patients (not far off from LH’s 56).
We certainly may see stat sig. in some of the endpoints even at N=56, guiding resultant phase 3.
As these results are three weeks earlier than most expected, I expect additional details in the coming hours and days.
Certainly you and many others here know all this better than I, but I thought it worth reiterating nonetheless.
Just to reaffirm, the smaller the observed clinical impact, the larger the trials needed to achieve statistical significance.
Clinical significance (does the patient benefit meaningfully) is a separate but related issue to statistical significance (are the results real/very unlikely to be due to chance),
Had CD12 critical intubated sub population Beeman standalone trial, it’s very marked clinical impact (82% days 14, still 24% at day 28/3 weeks after last dosing) would have achieved statistical significance with only 62 patients (not far off from LH’s 56).
We certainly may see stat sig. in some of the endpoints even at N=56, guiding resultant phase 3.
As these results are three weeks earlier than most expected, I expect additional details in the coming hours and days.
Certainly you and many others here know all this better than I, but I thought it worth reiterating nonetheless.
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