GreylockSec
Oct 3, 8:49 PM
$CAPR ...some interesting stats about 'If' the FDA might approve a 'major Amendment' much earlier than its PDUFA date, per Uncle Gemini-AI :
..."...The Regulatory Realities of Major Amendments
The FDA Utilizes the Extra Time: Historical tracking shows the FDA meets its adjusted PDUFA goal dates at a rate exceeding 90%. However, the vast majority of these decisions—whether approvals or Complete Response Letters (CRLs)—are announced in the final 1 to 2 days leading up to the final PDUFA deadline.
"Long Before" is a Rarity: The FDA rarely leaves months on the table after extending a clock. An approval occurring weeks or months before an extended PDUFA date typically only happens under narrow conditions, such as an unprecedented public health crisis.
The Criteria for Extension:
...If the data were simple enough to review ahead of schedule, it likely wouldn't have been classified as a major amendment in the first place..."...so it appears we're waiting until Nov 😎
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