We are exploring the use of a 5 year extension study in branded APS that is not included in the sponsor’s TMA. This is an extension of the original study included in the sponsor’s TMA. If the only methodological discrepancy from the initial pivotal trial is that the primary endpoint of PFS in the extended duration analysis was evaluated by Investigator Assessment, whereas the PFS presented in the original pivotal was determined by blinded, independent, central review (BICR), would the extended duration data be viable in a branded APS?
Please see Extension Study switching from blinded IRC assessment to unmasked investigator assessment.
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