nmbr1, I believe you are confused on a couple o
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Posted On: 08/12/2020 8:39:35 PM
Re: nmbr1stckpckr #49005
nmbr1,
I believe you are confused on a couple of points. If I am mistaken, I apologize in advance.
Clinically significant means a result that matters to patients, physicians, health care systems. (Cytodyns results, reducing worsening of symptoms from mild to severe, are more clinically significant, IMO than Gilead's reduction of symptom duration from 15 to 11 days).
Statistical significance means that a result in comparing two groups (placebo patients vs Leronlimab patients) is highly unlikely to be due to chance. The threshold is p<0.05, meaning that the probability of an outcome due to change is less than 5%.
The discussion of rerunning the CD10 trial as a phase 3, I believe, was a logical exercise to demonstrate why an EUA should be granted on their results.
They essentially said, rerun the same exact trial except NEW2 score is chosen as primary endpoint. .... get same statistically significant results...receive approval and take a victory lap.
I assume that everyone has concerns that the FDA might not do the right thing. This demonstrates, at least to me, how difficult it will be for the FDA to somehow diminish the importance of these results.
I believe you are confused on a couple of points. If I am mistaken, I apologize in advance.
Clinically significant means a result that matters to patients, physicians, health care systems. (Cytodyns results, reducing worsening of symptoms from mild to severe, are more clinically significant, IMO than Gilead's reduction of symptom duration from 15 to 11 days).
Statistical significance means that a result in comparing two groups (placebo patients vs Leronlimab patients) is highly unlikely to be due to chance. The threshold is p<0.05, meaning that the probability of an outcome due to change is less than 5%.
The discussion of rerunning the CD10 trial as a phase 3, I believe, was a logical exercise to demonstrate why an EUA should be granted on their results.
They essentially said, rerun the same exact trial except NEW2 score is chosen as primary endpoint. .... get same statistically significant results...receive approval and take a victory lap.
I assume that everyone has concerns that the FDA might not do the right thing. This demonstrates, at least to me, how difficult it will be for the FDA to somehow diminish the importance of these results.
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