Wednesday, April 05, 2017 10:48:22 AM
"Unfortunately, Bryostatin Phase 2a (single dose, safe, PK/PD positive) doesn't give much readthrough to Phase 2b (7 doses across 12-weeks, double-blind placebo controlled) SIB results.
So we have to rely on the extensive preclinical mouse/mammal models published by Dr. Alkon, upbeat scientific presentations at conferences by Wilke/Alkon, and 3 compassionate-use patients. "
Some of my thoughts:
I prefer that they have decided to run a properly sized, placebo controlled, blinded trial with efficacy as a primary endpoint, to actually (for real) give Bryostatin a chance to fail quickly.
Imagine if they tried to claim the drug was working using their 2a unblinded, non placebo controlled, underpowered, study results. Would you be skeptical? I would!
The fresh frozen blinded Alzheimer's brains that corroborated the PKC link is another piece of evidence for the approach outside of the mouse models and clinical trials to date.
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