You do not need top line data for other indications once this is approved to extend both insurance coverage for off-label and combination therapies and for expanding the label. Lots of that will be doable with Real World Data (RWD). That is the whole point of that new guidance and much of the reason for the 21st Century Cures Act (21CCA)
Top Line Data suggests additional clinical trials to expand the label and there may be some areas where that may be requested. But the 21CCA has reduced the requirements generally for access, threw off-label access and tools for getting insurance coverage as well as for expanding the labels for already approved drugs more rapidly and efficiently. Some interests do not like the new liberalization, but it is the law.
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