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Why can a negative trial still mean FDA approval?

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Failed trial, successful drug: How a negative readout can lead to FDA approval

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In our latest report author and biopharma consultant Frank David, M.D., Ph.D., explores the question, how can you tell if there's still hope a drug will be approved when a pivotal trial fails?

Although a failed late-stage clinical trial can mean bad news for patients, the drugmaker, and investors, it doesn't always mean the end of the road.

This report dives into the regulatory rules that give the FDA flexibility and aims to help investors and biotech companies evaluate negative clinical studies to assess whether there's still a viable path to market for their drugs.

While drug approval is expected to be based on safety and effectiveness, several drugs have been approved by the FDA despite mixed or negative clinical results, while others were rejected. Explore why by downloading this report.

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STAT Reports help business executives, researchers, consultants, and analysts navigate the ever-changing life sciences industry. Each report provides deep analysis of a particular issue in health care. Pick and purchase the reports that are most relevant to you.

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Wednesday, August 9, 2023

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