Pink Sheet Podcast: Twirla Adcom Surprise And Makena Adcom Questions
Pink Sheet reporters break down the surprising US FDA advisory committee endorsement of Twirla and the split decision on whether Makena should be withdrawn.
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Advisory committee members say clinical data proves the second shot should be considered part of the primary series, while Janssen wants it called a single-shot vaccine with a booster.
Many supporters believe Robert Califf checks all the boxes, but if nominated he would also face many familiar confirmation challenges.
Agency assessors couldn’t independently verify several Janssen analyses of booster shot data and raised concerns about small samples sizes and an unvalidated immunogenicity assay.