The accelerated approval process is currently giving hits and misses which rewards FDA roses or brickbats. While the intention is right FDA is reviewing this on a disease-by-disease (eg. Cancer) or category-by-category (eg. Gene therapies) basis and how they will consider PAA’s accelerated approval request will likely be determined by how many patients are getting significant safety and efficacy outcomes over base rates and where our therapy sits in their opinion.
AIMO.
https://www.cbsnews.com/amp/news/cancer-drugs-remain-unproven-years-after-fda-accelerated-approval-study/
https://endpts.com/accelerated-approval-will-be-the-norm-for-gene-therapies-fdas-peter-marks-says/
Ann: Final Ethics Approval for Open-Label MND Extension Study, page-25
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