Finally got to a computer. With the small N last go around in the non memantine population, anyone who did not get tested at week 13 or 15 could skew the results more than you would like so they averaged the 2 endpoints. We were stat sig at week 13 however, but even more stat sig when you averaged the 2 data points. Week 13 has always been the primary endpoint with the 30 day from last dose (day 77) always being a secondary endpoint to see how our MOA plays out with regrowing synapses.
I think the simplest explanation is that with larger numbers, the average is not really necessary and that the FDA encouraged this move to avoid any questions moving forward. I for one will be happy to see clean data at each of the data points. The average we got from the last trial certainly helped week 13 become even more stat sig, but it also hurt the delta of the 30 day follow up. If I remember correctly the delta increased a half point during those 2 weeks and that was using at least a couple patients' 13 week scores in with the average...presumably lower than a pure week 15 score would have been. JMHO
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