Remember the vote - is nothing to do about the previous questions which was discuss the merits of the trial and if you think a better one could be done.....
The vote is about if the data supports it working.......... If you include the older trials in 'data' then it doesnt work..... if you include only the newer drug in the older trial then it does, If you don't think the null hypothesis is correct it doesnt.....
Ryoncil: ODAC/FDA Meeting Discussion, page-1446
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