Replies to post #3188 on UniCycive Therapeutics Inc (UNCY)

[Whalatane]

FDA Form 483 is a central component of the active securities class action lawsuit against Unicycive Therapeutics (UNCY).

The lawsuit, filed in the Northern District of California (Case No. 3:25-cv-06923), centers on allegations that the company misled investors regarding its readiness to meet FDA manufacturing standards for its lead drug candidate, oxylanthanum carbonate (OLC).

Role of Form 483 in the LawsuitThe legal claims specifically involve the following events related to FDA inspections:

Identification of Deficiencies: In June 2025, Unicycive disclosed that FDA inspectors had issued a Form 483 to a third-party manufacturer tied to the OLC program, citing current Good Manufacturing Practice (cGMP) deficiencies.Impact on Regulatory Approval:

This Form 483 effectively blocked label discussions with the FDA and ultimately led to a Complete Response Letter (CRL) on June 30, 2025, which officially denied approval for OLC due to those same unresolved manufacturing issues.

Investor Allegations:
Shareholders allege that the company overstated its ability to satisfy FDA requirements throughout the "Class Period" (March 29, 2024, to June 27, 2025) and failed to disclose the severity of the manufacturing risks identified during these inspections.

Lawsuit Status
As of early 2026, multiple law firms, including Rosen Law Firm and Levi & Korsinsky, are representing investors who suffered losses following the 40% and 30% stock drops triggered by these revelations.

They disclosed the Form 483 about 10 days before the CRL last yr in June .
They probably sat on that as inspections are supposed to be finished and filed , at least 30 days before approval date .

If they get another Form 483 we should fire the CEO . He's Indian . He knows how it works there . I want him living in the plant thats getting inspected .
I'll need to be " contained / restrained " if they F this up ...:--)

Kiwi