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growingpain

10/21/22 9:29 AM

#379245 RE: Investor2014 #379205

The change is a way to almost directly compare to the lecanamab results



The change allows them to do a one-sided t-test which produces half the p-value of the usual two-sided test, so if they follow this approach, they are more likely to meet the endpoints. However, a one-sided test is almost never used in practice so I have doubts about whether FDA or any other agency would accept that.

With regard to Lecanemab, I had the impression that the original endpoints were more aligned with the Lecanemab trial.