Havasu, Your numbers seem to be correct. My po
Post# of 153887
(Total Views: 574)
Posted On: 09/15/2020 7:30:14 AM
Havasu,
Your numbers seem to be correct. My point was which criteria the FDA will use: one or two tailed.
Read More: https://investorshangout.com/post/view?id=589...z6Y6nGdD31
The difference is that in a two-tailed test half of your alpha (0.05) is used to test the statistical significance in one direction and half of the alpha to test in the other direction. That is 0.025 in one side the other 0.025 in the other side.
In our case, the FDA can ask: con Leronlimab improve the clinical outcomes ??? (one-tailed test)
Or rather: can Leronlimab improve or make worse the patients clinical outcomes ??? (two-tailed test).
Normally as a drug is not known (theoretically) the FDA takes the two-tailed test which is more restrictive (difficult to achieve).
In our case, we know that there are no pervious SAE's (Leronlimab is safe) and FDA con settle a one-tailed test, that is: how much LL improves the patients (without entertaining the possibility of LL worsening them).
Your numbers seem to be correct. My point was which criteria the FDA will use: one or two tailed.
Quote:
One thing I don't understand here is that TechGuru thinks that since the wolframalpha is a two tailed test. I am not sure if the two is because of two normal distributions (one placebo and one LL) or two tails on the plot (one tail on left side of graph, one tail on right side of graph).
Read More: https://investorshangout.com/post/view?id=589...z6Y6nGdD31
The difference is that in a two-tailed test half of your alpha (0.05) is used to test the statistical significance in one direction and half of the alpha to test in the other direction. That is 0.025 in one side the other 0.025 in the other side.
Quote:
When using a one-tailed test, you are testing for the possibility of the relationship in one direction and completely disregarding the possibility of a relationship in the other direction.
In our case, the FDA can ask: con Leronlimab improve the clinical outcomes ??? (one-tailed test)
Or rather: can Leronlimab improve or make worse the patients clinical outcomes ??? (two-tailed test).
Normally as a drug is not known (theoretically) the FDA takes the two-tailed test which is more restrictive (difficult to achieve).
In our case, we know that there are no pervious SAE's (Leronlimab is safe) and FDA con settle a one-tailed test, that is: how much LL improves the patients (without entertaining the possibility of LL worsening them).
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