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This is far from the first time it's used a single arm Phase III trial, which has seen historical success with drug approvals. Why else may it have approved it As a couple bears mentioned, there is a significant ethical concern related to not providing potentially life saving treatments to infants as part of a control group (this is not an issue, but a valid rationale for this lethal disease). This is not to say that there is no control in a single arm study; to the contrary, the control is an accepted "historical response" the deviation in the treatment group from the well studied and accepted normal progression of the disease.
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