That is not a hard event... so it’s an attempt to save something that is not really relevant.
Upon their determination that they could not possibly even apply for approval, which is not the same as failure though their opinion could be wrong and there might be no chance of approval, they might be best served by not delaying their announcement. But I don’t see the difference there between marginal, failed or successful. When they are ultimately comfortable that they understand their data fully and have characterized it fully, in whatever way that might be, perhaps a scientific paper where critics get their data and review their conclusions, they might still be embargoed.
So they would be as transparent as possible and as complete in their analysis and explanation as possible. If it were a futility finding, early on, where they discontinued the trial, or they knew it failed at an early efficacy review, that’s an easier call.
In this instance the blinded data is so intriguing and there are sub-categories of patients discovered during the course of the trial, so I would expect that they’d want to fully understand the data and characterize it fully before they announced anything. It seems unlikely, given the blinded data that they would even mathematically would be able to fail across the board, particularly given the updated endpoints and SAP...
The 4 day rule in this complex a context with a category of data that is not listed under the mandatory disclosure list, is not the relevant issue. Fraud lawsuits due to misstatements, miscommunications or selective disclosure are the relevant issues. And other than selective disclosure (Reg FD), the other issues do not have a set timing other than the regular quarterly and annual reports, where they have to be careful not to miscommunicate. So the issue is trying to be as transparent and disclose meaningfully as soon as it is reasonably practicable give a broad range of discretion for them as managers and some potential cautionary areas with regard to any communications from the relevant regulators. They should avoid misleading, or leading investors in without disclosure, without a reasonable business judgment justification, like that they were reviewing data and key issues with subject matter experts.
