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Demers A, McNicoll N, Febbraio M, Servant M, Marleau S, Silverstein R, Ong H
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The stated reason was questions about bioanalytical method validation that had surfaced late in the review, questions that could affect interpretability of certain pivotal study data. In plain terms: the agency developed a concern about whether the assays used to measure the drug in the pivotal trials could be trusted, and it pulled the meeting rather than hold it
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