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Surprise Changes In The Middle Of A Phase III Study Are Probably Bad
What on earth would make a biotech company change the primary endpoint half way through a Phase III program and not discuss it with the FDA? There are at least two scenarios, neither of them good.
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It takes a lot of negotiation with regulators, advisory boards, and alignment between commercial and portfolio management teams to define and agree a clinical trial protocol. Why on earth would companies change it once a study is underway?