Seems highly unlikely that they’d conditionally approve 2-73 based on 22 of 32 patients. The trial is small, unblinded and with out a placebo arm.
But if you have 24 weeks of data from 450 patients in a properly conducted trial, conditional approval could be a possibility. Unfortunately, as someone pointed out yesterday, AVXL will not be revealing interim data on the phase 2b/3.
I believe that could be part of the data to tip the scales, but I believe they will want to observe improvement in the current trial that parallels the P2a.
I suspect that the TGA weighed in on trial design and they have the endpoints and biomarkers they want to see confirmed.
The information in the post below confirmed for me that if 2/3 of trial patients start sleeping better and have improved quality of life they will know in real time.
They will have a magic number in mind that is sufficient to confirm the results of the first trial and that could trigger the provisional approval.
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