I'm VERY excited about the poster.
And, I'm finally understanding the significance of what the stats expert (hired by NTRP earlier this year) did to help analyze the data and come up with a protocol that is more likely to succeed than the previous protocol.
Here's the primary endpoint of the previous P2 study:
The primary statistical objective for efficacy was to estimate the effect of bryostatin on the mean change in the total SIB score after 12 weeks of treatment, assessed at Week 13 (day 91).
Here's the primary endpoint of the current P2 study:
Efficacy: change in the Severe Impairment Battery (SIB) score obtained between the average 13 and 15-week scores and the baseline score
From the poster today:
Moreover, to avoid large potential intra-patient SIB variation over time, for the post-hoc analyses, we considered the change in average score collected during week 13-15 from baseline as the endpoint.
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The stats expert must have noticed 2 things:
1) Even though there is significant improvement in SIB score over time, there is a large variability when comparing one test to another test in individual patients. Large variability in the pooled data is damaging to the final p-value analysis. By taking the average of week 13 and week 15, this dampens the variability, and HELPS meet statistical significance.
2) The average score at week 15 is a higher average score than the week 13 score, so the statistical analysis will also take advantage of the higher scores when taking the average of 13-week and 15-week.
And, to prove it, they took the previous trial non-memantine data and plugged it into the current trial primary endpoint!
This gives us a much better chance at meeting statistical significance next July.
AWESOME!
