Winst gevend schreef op 21 juni 2022 16:28:
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One of the co-primary endpoints looked at lymphadenopathy lesions. The trial linked leniolisib to a -0.30 mean change, compared to a -0.06 change in the placebo cohort, resulting in a hit against the first of the co-primary endpoints.
The second co-primary endpoints measured the change in the proportion of naive B cells from a baseline level of less than 48%. Pharming saw a 34.8% increase in the leniolisib arm, compared to a 5.4% decline in the placebo cohort. The difference was big enough for the trial to hit its other co-primary endpoint.
Als met deze beide eindresultaten het placebo ver achter je laat, en er geen alternatief is,
lijkt mij dat die vraag hiermee beantwoord is, in afwachting van de FDA-aanvraag.