@admin Can PAAB please clarify if it is one or both of these criteria for extension trials that need to be met in order for a reference to be accepted:
Out-of-label studies evaluating a duration of use that is longer than the product’s pivotal trials for the corresponding condition
Published, pre-planned extensions and subsequent interim and final analyses of randomized, controlled trials (RCTs)
Additionally, should it be disclosed in the extension publication that:
“These post-hoc analyses evaluated several endpoints related to response, complete response, and clinically relevant response. Of note, in these post-hoc analyses, statistical tests applied to these endpoints were not prespecified in the original study and may be considered hypothesis-generating in nature.”
would the PAAB accept this publication as a reference to support advertising messages?