Posted By
Narayan Rao
22-Feb-2024 18:21
Found In
Egroup:
Regulatory Open Forum
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Ok, I now understand what you are asking! I am familiar with oncology approvals rather than other therapeutic areas, so Yes, one can add a second indication as a full/regular approval (i.e. no confirmatory trials required for this specific new 2nd indication say for example, 2nd indication is supported ...
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