Doxtator
Sep 18, 5:38 PM
How confident should we be in a clean inspection for
$UNCY? Here are the numbers.
I pulled the curated FDA CRL dataset off open.fda.gov.
364 letters, 52% referenced CMC, though some of the data is heavily redacted. Median time from CRL to approval was 17.9 months.
On the unapproved side: 119 unique applications with at least one CRL. 25 went on to a second (21%). Of those 25, 4 got a third (16%). So about 1 in 6 of the twice-rejected keep getting rejected. Not insignificant.
I'd be careful leaning on that base rate though. A May 2025 executive order pushed domestic production and tightened foreign inspection policy.
Unicycive's CDMO is Shilpa Pharma in India, inspection timing and outcome carry more risk than the aggregate historical data assumes.
$GRCE received a CRL on cGMP status at its CDMO and is now contracting a second U.S. source in parallel while attempting to have the original CDMO pass inspection.
Working through additional FDA data sources. I'll keep you posted.
@Eire32
