The main criticism of the Brave study has been and will be the small number of patients in the study...Lab work is being accompanied by psychology evaluations which are less quantifiable...The important assessment will be whether the Vascepa group did better than the placebo group in both the scientific and the "less scientific" assessments....My assessment is that...It is likely that the results will not reach statistical significance in a comparison between the active and the placebo groups...but the results will trend in favor of Vascepa being an effective treatment for Alzheimers...with placebo like side effects in a terribly disabling disease.
Whether this small study will be enough for the FDA and the EU to grant it validity without a larger study remains to be seen.
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