Monday, April 27, 2015 12:36:30 AM
Struck me that the HAhigh group is lowest responder to standard of care so it did not seem ethical to put them through this but I guess this is the only way to prove stat. sig. enough for approval. I could see this if we were looking at closer data of say 40% orr and 7 months pfs compared to soc but a 70% orr and 9.2 month pfs should be able to be confirmed or denied without a control. We know that AG treatment has not, can not produce these results so what purpose does the control serve except to confirm that HAhigh patients do worse than HAlow on soc. Wouldn't it be more beneficial to show data from a larger number of HAhigh patients on PAG in a shorter amount of time to confirm or deny sig improved efficacy?
My logical laymans brain at work, definitely not scientific.
Never argue with a fool, for after awhile, it becomes difficult to determine which is the fool.
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