The fact that ! Potency Assays ! are featuring so prominently in the go/no-go decisions on lifesaving drugs, decisions which are adding months to development timelines, reflects a serious problem with FDA.
$IOVA $SRPT

If they insist on elevating their importance to this degree, they must ALSO elevate communication w/ sponsors commensurately, to clarify requirements. These are all resolvable matters that shouldnt be adding to timelines. If u can't inc communication, drop this perverse agenda

But, I'm shouting into the void. Fda are perfect angels and our "national treasures" who can do no wrong... letting children die because of i dotting ventures