While I am not 100% sure, I believe the levels for "success" are pre-determined in the study information provided to and agreed upon by the FDA. If the specific numbers are met, it is a success. If not, then it fails. I think these numbers are publicly available in the parameters of the study, but I have not looked for such information.
Opinions on what would constitute Rit "success"....Is this thing black and white?
Not even close to B&W unless you limit it only to PE results, whereas many here believe the real value of the V franchise will come from the SEs. As far as the PE RRR, look at what happened to FOURIER results - 15% sucked according to many doctors, they wanted to see 25% or more for RRR, although part of their opinions may have been influenced by the high cost of PCSK9's, i.e. "not worth the money spent", for which they had a great point - cost was something like $2M to prevent one event. IMO if we don't exceed 25% reduction on PE we're probably toast, unless some important SEs get far greater results, like the JELIS subgroup numbers, but for hard endpoints, not soft like JELIS had.
Dunno what you mean by "FDA unconditional approval" - that's pretty B&W - they either approve the sNDA or they don't. If you mean "could FDA try to torpedo results in an Adcom and affect the pps", that's possible I guess, but would be a short term problem assuming we get approved anyway.
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