Tuesday, April 21, 2020 3:11:57 PM
"A significant imbalance (4.8 points) in the baseline Severe Impairment Battery ("SIB") scores occurred, by chance, between the Bryostatin-1 treatment group and placebo group," stated Dr. Daniel Alkon, Neurotrope's President and Chief Scientific Officer. "After consulting with our Scientific Advisory Board and statistical experts, we were advised that, in a small study such as this, a baseline imbalance could prevent a definitive analysis of Bryostatin-1 treatment versus placebo in SIB scores at the primary (Week #13) and secondary endpoints as provided in the original Statistical Analysis Plan ("SAP")," stated Dr. Alkon.
"Due to the baseline imbalance observed in the study, and because a clear signal of benefit could be observed in the raw data from the pre-specified Moderate Stratum, we conducted a post-hoc analysis using paired data for individual patients, with each patient as his/her own control," stated Kazem Kazempour, Chief Executive Officer of Amarex,
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