GREY:CLAZF - Post by User
Post by
HighSkies2019on Apr 25, 2021 11:15pm
319 Views
Post# 33064837
Registration For Market ...last sentence
Registration For Market ...last sentence I also think that maybe we will possibly could get FDA accelerated...I pulled this from the Claritas animal study.... Prior to initiation of Phase 1 clinical studies in humans, the FDA requires a number of GLP studies to be performed in animals. The positive results in the canine toxicology studies that we are announcing today, together with the positive results in the rodent toxicology studies that we announced last week satisfy the FDA requirements for safety toxicology studies in both species that are a prerequisite for initiating Phase 1 studies in humans and for registration for the market, stated Robert Farrell, Claritas President and CEO.