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STOCKWATCH: The death of surrogate markers

This article was originally published in Scrip

Executive Summary

Over the past week investors have had cause to rue the vain attempts by some biotechnology companies to get their drugs approved on the basis of indirect markers of disease which are not clinical or functional – the so-called surrogate endpoints. The surrogate endpoint debate is coming back to bite those who have invested in companies whose management teams prefer to pay themselves big bucks, rather than spend money on a definitive Phase II or Phase III clinical trial. The FDA also seems to be going cold on accelerated approvals based on surrogate endpoints.

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