Monday, September 19, 2016 10:42:43 AM
Preclinical work showing safety does not substitute or replace a Phase 1 showing safety... it only entitles them to go show the preclinical work to the FDA so the FDA allows them to go to Phase 1 where they dose humans.
Why would the FDA have granted Rexista PODRAS "fast track" designation if it's rolled into the Rexista NDA... and the Rexista NDA is not granted fast track... how are the 2 kept separate and apart???
All in my VHO of course.
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