iclight,
You might want to check when the L Phase 3 started and when the Medicenna trial started. FDA had their chance to insist on patient level data before trial start when they insisted on the crossover to a potentially active treatment which they knew could interfere with interpretation of treatment activity and trial results. Sure, FDA’s decision was the right thing to do for the patients but now their interference with the trial design and the screening halt, which led to 17 SOC/placebo patients being kept out while all treatment arm patients were enrolled, needs to be redemptive for the trial, the company and for future trials that will consider patients enrolled into SOC without hope for a better outcome as unethical when comparators exist that can be utilized instead. One of those comparators may end up looking a lot like what NWBO did in their L Phase 3 trial if my hunch is correct; ). Best wishes.