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Monday, May 21, 2018 11:46:03 AM
What percentage of the patients in our confirmatory trial are expected to not have Alzheimer's?
Can Bryostatin successfully treat those dementias included in our confirmatory trial that are not AD (but look similar to AD on neuroimaging)?
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These questions are absolutely crucial to how well our confirmatory trial is designed.
On sub-group analysis, there were patients in the non-memantine Bryostatin group who did not respond to treatment. I expect that will happen in the confirmatory trial, as well.
Increasing the number of patients will certainly help the statistical analysis in the confirmatory trial. (The sub-group analysis had 25 patients; the confirmatory trial will have 100)
But, if we get an imbalance of patients in the Bryostatin group who don't respond to treatment, it will adversely affect the outcome.
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