Colin Macaulay retweetet
This week's Biotech Scorecard newsletter: The old Vinay Prasad never left. He just changed jobs
Submissions to the FDA are handled by teams of reviewers, of course. But when I look across all of these recent cases, I see a consistent throwback to the old Prasad — questioning the legitimacy of biomarkers, surrogate endpoints, and single-arm clinical trials, even in the setting of rare diseases.
In some of these rare-disease drug rejections, Atara $ATRA and Regenxbio $RGNX are good examples, Prasad or the staffers he directs aren’t following the agency’s own guidance. Companies are told early that their clinical development programs meet FDA requirements, but then, almost arbitrarily, the FDA changes the rules.
Uniqure $QURE and its gene therapy for Huntington’s disease have been in a holding pattern for months because guidance it received long ago from the FDA is now, under Prasad’s watch, null and void.
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