Itvisma: what safety margin did regulators accept?

“These toxicity findings precluded the determination of a no-observed”

“At 6 weeks post-administration, all dose levels resulted in acute, minimal to moderate mononuclear cell inflammation and neuronal degeneration across multiple anatomical sites, including the cerebrum, cerebellar white matter, brain stem, dorsal root ganglia, and various nerve structures (trigeminal, dorsal spinal, spinal, and peripheral nerves).”