Not sure if this applies to us but in some cases of unmet needs/fast track pathway the FDA can give marketing approval on intermediate P3 results with 'rolling reviews' over the extended trials and also request P4 post marketing studies to validate additional labelling claims after initial approval. This pathway can be determined following review of P3 protocol submission/approval process. I guess in some ways similar to TGA provisional approval pathway.
https://www.fda.gov/media/86377/download
Not sure if this applies to us but in some cases of unmet...
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