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DewDiligence

11/01/22 10:54 AM

#244375 RE: dewophile #244374

Correct—my bad. The clinicaltrials.gov listing (https://www.clinicaltrials.gov/ct2/show/NCT04424316 ) describes the two primary endpoints as “the incidence of medically attended severe LRTI” and ““the incidence of medically attended LRTI.” I.e., the only difference between these two endpoints is the word, “severe.”

The trial was statsig on the “severe” primary endpoint and non-statsig on the all-cases primary endpoint; however, PFE says that, by prior agreement with the FDA, only one of these two endpoints needed to be met.