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Biotech / Medical : Immunomedics (IMMU) - moderated
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To: ghettogoulash who wrote (63283)11/5/2025 1:23:04 PM
From: ghettogoulash1 Recommendation

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jhcimmu

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Two things I don't like about Sarepta's spin on trial data: (1) The Statistical Analysis Plan of a clinical trial has a threshold for missed doses after which a patient is then disqualified. In this case, the missing data points are then "estimated" (using MMRM, for example) to account for those gaps rather than simply excluding the patients. This is known as Intent-to-Treat (ITT) Analysis and is the FDA gold standard in confirmatory trials. Furthermore, upon seeing a significant disruption by Covid, study officials would certainly have amended the SAP with a sensitivity analysis to account for such an "intercurrent event." But this must be done before unblinding the data. (2) Even when accounting for Covid in a post hoc Hail Mary, ESSENCE is nowhere near stat sig.
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