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Good Morning @kshulist In general terms, the linkage would have to be assessed to determine its acceptability. While it may appear to be less of a concern linking unbranded to unbranded, the linkage would be assessed during the review process where additional guidance could be provided in the context of the specific tool/message. There are scenarios where a deep link is fine and where it is not ok. For example, deep linking to a page which focuses on the sponsor’s product, even if it’s third party generated, from a sponsor generated unbranded APS, would not be acceptable. Apply general linkage principles to ensure that you are considering both the regulatory audience and content being linked.

Hello @kshulist This answer is provided with the understanding that the nominal p-value is not in the product’s TMA. The application of the above would depend on why the p-value was nominal. It can be from different reasons and the nominal p-value may become a meaningless number if the assumptions of the statistical model used to compute it do not hold. Violating any of the varying prerequisites of a significance test might render the nominal p-value not acceptable. As such, the ability to present the data and the potential types of claims in an APS would require consideration of the statistical analysis. For the example in question, if a statistically significant p-value is nominal simply because it was unadjusted, a claim neutral presentation could be considered per the prior Q&A.