Yes, you are absolutely right... Forgot about that
Post# of 153778
(Total Views: 755)
Posted On: 07/03/2020 1:39:54 PM
Yes, you are absolutely right... Forgot about that - always have "blinded" in my head lol. (On the other hand, not 100% sure what/how much BP actually shares).
However, as you note, that raises a whole bunch of other questions regarding FDA involvement, statistical reasons...
I think they re-evaluated the situation and saw that n=51 was a premature decision and an inappropriate sample size for an interim analysis, and therefore decided to blow it off, especially since they have a near-term shot at success with the overenrolled m/m trial. Agree that it is unsatisfactory not to have clear guidance what n will trigger an interim analysis... but looking at the Regeneron and Sanofi trials I don't see why FDA wouldn't allow an interim analysis with n=180 or with the numbers we already... I think CYDY aims at an halt for efficacy and has a certain sample size in mind that would provide a low-enough p-value.
However, as you note, that raises a whole bunch of other questions regarding FDA involvement, statistical reasons...
I think they re-evaluated the situation and saw that n=51 was a premature decision and an inappropriate sample size for an interim analysis, and therefore decided to blow it off, especially since they have a near-term shot at success with the overenrolled m/m trial. Agree that it is unsatisfactory not to have clear guidance what n will trigger an interim analysis... but looking at the Regeneron and Sanofi trials I don't see why FDA wouldn't allow an interim analysis with n=180 or with the numbers we already... I think CYDY aims at an halt for efficacy and has a certain sample size in mind that would provide a low-enough p-value.
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