“This simply means the significance found could be a product of statistics, rather than the treatment being efficacious.”
pretty redundant because there is always type I and type II error risk in any statistical analysis…
And could be “extremely concerning”, or could simply be analysis of the data and they are trying to find the benefit of the product (rather than shrug the shoulders and give up). Guess it depends on your biases and how you want to spin it.
Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-418
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