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hiwatt1959

06/23/17 11:57 PM

#8339 RE: damizo #8338

This from their website under June talking points, page 12.
Expected Regulatory Path Forward for Proellex
®
¦ Repros empaneled a group of liver experts to review data and
provided opinion to the FDA in May 2017
¦ Reached agreement with division to accept additional information
from Repros, including opinion from company’s liver experts, for
submission to FDA internal liver panel
¦ Submit clinical protocol along with supplemental information
¦ FDA feedback may take 2-3 months