May. 29 at 8:54 PM
$IOVA
$REPL ’s CR had nothing to do with some leftist conspiracy .
Makerery was a Trump Hand picked FDA chief who’s team basically acted up on the precedent traditional method of Registrational p-3 trials need to Double Blind & closed label. Before
$REPL there were many others that got the same fate because their trial did not address the Control group & the Placebo arm. For example investors lost their livelihoods when
$BYSI was rejected because of their single Arm, open Label trial that looked good on paper, was asked to start a Double Blind Placebo controlled trial CR. and there are many more examples like this. Therefore the CR given to
$REPL was justified.
