Post by
Forestview on Aug 03, 2021 7:53am
I don't get it
So, they don't have all the facts as to why those three people had evelated liver transaminase, but they release a PR? Is this another bone headed move from the management team, or is this a legal/ethical requirement?
Comment by
WalkOverTheStrt on Aug 03, 2021 8:10am
Near positive it is a requirement as these would be considered a SAE technically speaking... I watched ARWR due this pause on a PH1 drug only a few weeks ago b/c data from the lungs of rats showed inflamtion when the humans in PH1 had not... 99% certain this is a required PR