I was about to reply to you in the other thread then saw this reply. There has been little substantive discussion on these results here so great to see your comments and I suspect you know more about this company than I do.
Not sure about the comment on the 7 excluded (you might be right but I don't have time right now to have another look), but we seem to agree they should be excluded.
I agree with you that the Remission 1 group results are bad for CVAC and the Remission 2 group results are good.
That means the company may have to separate the Remission 1 and Remission 2 group results to show the better results in the Remission 2 group.
I have 3 concerns: 1. What is the likelihood of getting a significant result in such a small group (ie Remission 2)? Impossible to know without more data on variance, if there is a big difference, it may be possible. I'm not a statistician but it seems a tough ask. 2. This may narrow any efficacy claim ie to patients in second remission if the same results occur in later trials. 3. It probably has an impact on the design and statistics of later trials.
I presume Prima is looking at all these issues with their statisticians but I doubt we will hear more until the final results.
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