UniCycive Therapeutics Inc (UNCY)

[Whalatane]

Thx for reviewing those .
The issue for UNCY right now is the time line if they get a Class 2 re submission .
From the Seeking Alpha article

Milestone Typical duration (precedent) UNCY base-case date
Type A meeting minutes received Day +30–45 Aug 2025
Collection of comparability & vendor qualification data 4–5 months (Astellas zolbetuximab fixed a third-party issue in 4 mo) Dec 2025
Resubmission (likely Class 2) Sponsor-controlled; 6–9 mo median for manufacturing CRLs Jan 2026
FDA review clock (Class 2) 6 months Jul 2026
Projected new PDUFA — ~late July 2026

Can the FDA's new AI system ELSA cuts weeks or months off this schedule .
First thing we need to know ...Is it a Class ! or Class 2 re submission
Assuming a Class 2 ...Can they re submit by Sept 9th and have the FDA accept the re submission by Oct 9th 2025 .
If so ELSA is expected to cut several weeks off the CMC/ Facility Re review and several days off the Mid cycle review .

Hopefully UNCY will provide an update on Aug 15th re time line ...especially date of re submission .

The SA article time line is longer than I expected . Hopefully with ELSA some time consuming checking of data or data collection can be collected and reviewed faster .
Above is just a quick summary of...may do more DD later
Thx for checking it out

Kiwi