Zalmoxis: what safety margin did regulators accept?

“In preliminary studies a dose dependent GvHD-induced mortality was observed with a 100% incidence at the dose of 20x106 cells/mouse, which was chosen as the target dose. Of note, the chosen target dose is around two log higher than the proposed clinical dose, thus providing large safety margins.”

“Non clinical safety data obtained in two different immunedeficient animal models for Graft Versus Host disease did not indicate special hazards for humans, but allowed only a very limited safety assessment.”