Because they are going for full MAA authorization, IMO reference to P3 implies your scenario 3 (highly neg) and makes neutral reference less likely. Slightly negative scenario is also possible if they mean FDA. We should see clarification at JPM.
P4 trials can serve different purposes and I have done at least 6, mostly in MS, none in AD. A confirmatory P3 implies a trial needed for approval in the first place (i.e not convincing enough data with initial study/studies). One was to garner additional cardiovascular data that was required in the FDA approval package. One was to gather minority data after approval for a drug approved after 2 P3 studies in EU (98-99% white)- this was not required by the FDA but encouraged by their guidance. One was to contribute to a large database to help quantify risk of a specific rare adverse event. The other 3 were mostly for marketing reasons - methods to reduce GI side effects with one medication not required by FDA. Another was additional switch therapy safety data for a drug already marketed. Many P4 trials are open label as they do not impact an FDA approval
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