second bullet point … the trial was designed to test for non-inferiority and it failed to prove that, so the question is will FDA take these results as “comparable or better outcome” or FDA will require a new trial designed to prove statistically as primary outcomes?
intuitively, it feels that they should be ok… they were testing for non-inferiority but ended up with something that may look like superiority (though not statistically proven)
however, right now it failed to be that catalyst to propel the share price. Instead it has lowered the probability of approval in H2 2023 and it also resulted in a lower share price.
second bullet point … the trial was designed to test for...
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