Anyone have an idea as to whether they would have a placebo arm in a B-OM Phase III trial? Usually they do but since there is no alternative therapy that is worth a damn, why put some poor souls thru a case of OM if they don't need to? Give every patient B-OM and see what percentage develop the sores. If none to extremely few do, then B-OM is obviously working great.
This would also really motivate ALL prospective patients to join the trial as they have nothing to lose. Should make the total necessary enrollment go extremely quick and end the Phase III in a very short period of time (as far as Phase III normal time takes).
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