“Conflicts with what Janet Woodcock, head of the
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Posted On: 03/07/2021 8:47:19 AM
“Conflicts with what Janet Woodcock, head of the FDA recently said about P values during a pandemic.”
We haven’t been told what the p value is for the primary endpoint of CD12 (28 day mortality). The value may not been close to .05 as I believe NP would’ve mentioned it in the PR if it were. He said the data will be published in a journal so we’ll eventually be provided the exact number.
In regards to the age adjustment analysis, the FDA will never grant EUA/full approval based on a statistically significant endpoint from such an analysis. That analysis can be used to guide a better designed trial to target mortality but it doesn’t appear CYDY will go that route (time, cost, etc.)
We haven’t been told what the p value is for the primary endpoint of CD12 (28 day mortality). The value may not been close to .05 as I believe NP would’ve mentioned it in the PR if it were. He said the data will be published in a journal so we’ll eventually be provided the exact number.
In regards to the age adjustment analysis, the FDA will never grant EUA/full approval based on a statistically significant endpoint from such an analysis. That analysis can be used to guide a better designed trial to target mortality but it doesn’t appear CYDY will go that route (time, cost, etc.)
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