RE:RE:RE:RE:How does Accelerated Approval work May 07, 2024 - “The facts clearly show the accelerated approval pathway is providing new hope and meaningful new treatments for patients to fight their disease, and why we shouldn’t be misled by biased studies that distort reality,” concludes BIO.
https://www.bio.org/gooddaybio-archive/setting-record-straight-accelerated-approval
May 08, 2024 - "Using a biomarker to obtain accelerated approval is key to get an initial approval for therapies that address devastating diseases, rather than wait for a clinical endpoint to show efficacy in a longer trial" according to the FDA’s Peter Marks, M.D., Ph.D.
“The wherewithal to do a three-year study or a four-year study without having a revenue stream, it's just beyond many companies that are startups. So having the accelerated approval process is a way to get there,” Marks said during a recent American Society of Gene and Cell Therapy (ASGCT) meeting.
As long as a biomarker is scientifically validated, Marks said, more products can get to the patients that need them.
https://www.fiercebiotech.com/biotech/preventing-3-billion-visits-fda-year-cbers-peter-marks