No, the OS metric has obviously been compromised within the study due to the ethically correct FDA requirement of a crossover to active treatment. The difficulties with cancer trials continue, between good ethics toward current trial patients and good responsibility ethics to other and future patients who need better therapies to combat such awful diseases with GBM competing in the top quadrant. The OS data provided by the trial can obviously only be used to compare OS from initially active treated patients in the study to SOC data outside of the study, which I think will be accepted by the agency in a case like this if it comes to that. I do not think the agency will allow the apparent benefits of a therapy like this to be kept away from patients for years more when science and innovative study construct can be utilized to resolve this set of constraints. There are public protective mechanisms like market monitoring, additional focused scientific studies, and, conditional approval to protect the public, made much simpler when safety is not a major consideration. Would anyone want to be the subject of study at FDA when in the future facts reveal years were lost due to an FDA imposed study constraint when good science, judgment and innovative tools could have been used. Realizing the constraints that do exist, it is my opinion this is manageable by FDA and the agency has the expertise and where-with-all to make it happen.
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