May. 19 at 2:23 PM
$OTLK Can someone please try to find one example (or more) of a precedent to request a new trial after an FDDR meeting when a new trial wasn’t explicitly requested in one or more CRLS? Or an example when a request for a new trial was given in a list of choices like x months real world evidence, bridge study, 24 week trial with a 12 week primary endpoint?