In this study design, 272 patients are randomized to drug and placebo, and at some point, placebo patients are crossed 273 over to active treatment. If patients in the trial who were initially on placebo and then assigned 274 to active treatment fail to catch up (after a reasonable period of time) to patients who received 275 active treatment for the entire duration of the trial, a persistent treatment effect on disease course 276 would have been shown.
FROM FDA draft guidance Feb 2018 posted earlier post 173439.
Can we say if anything from the A2-73 trial indicates any Australian safety trial patients were subsequently dosed and any results? Functional testing and RWE/RWD seem more useful. If so, does this suggest early approvals are possible according to this document, in spite of small n?
Market Data 
Markets 
