Your concern not mine. JAMA Oncology was part of the process to get peer review acceptance of the SAP. This can be considered on its own or as part of the exceptions to adequate and well controlled studies pathway which was part of the guidance. Regulators want adequate measures of treatment effect in place before final adjudication so that the true scientifically determined benefit of the study can be determined for the sake of patients. That guidance is FDA guidance and FDA only “accepts” SAPs before a positive marketing approval decision officially “approves” them. MHRA approved the SAP ahead of time so your concern only applies to FDA review at best and remember, FDA was part and parcel involved in lowering the powering of this study as well as mandating a crossover which was the RIGHT MOVE for rGBM patients as they benefitted quite well because of this. So what is your point?; ). Is it that FDA would have been more difficult to start with because there is more doubt created by their approach? Well then you just applauded Linda for being one smart cookie for applying to MHRA first. I applaud with you!; ). Best wishes.
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