Replies to post #1434 on 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

[Whalatane]

Just a followup on AI in healthcare
Cardiology

Artificial intelligence (AI) is rapidly transforming the field of cardiology, leading to significant advancements in diagnostics, risk assessment, personalized treatment, remote monitoring, drug discovery, and surgical assistance. These innovations hold the promise of enhancing patient care, improving outcomes, and streamlining clinical workflows.

Wife says they are increasing using AI in her Renal dept ...to streamline work flows .

Question is. " Will it speed up UNCY's re submission process "
Lets hope so

Kiwi