Replies to post #2058 on UniCycive Therapeutics Inc (UNCY)

[Whalatane]

It's the best that I've tried . Sometimes I'll cross chk with GROK and Googles bolt on version ( which is not that great )

Kiwi

[Whalatane]

Groks take

Unicycive Therapeutics (NASDAQ: UNCY) has no publicly disclosed contract supplier or manufacturing partner specifically for oxylanthanum carbonate (OLC) in the European Union as of November 13, 2025.
Unicycive's primary contract manufacturer for OLC is Shilpa Medicare Ltd. (an India-based CDMO), under a long-term supply agreement signed in 2020 and amended in 2024 for commercial-scale production (primarily to support U.S. launch and global needs).
A backup third-party vendor (unnamed in public filings) was referenced in 2025 FDA Complete Response Letter discussions, but no location or identity was specified for EU purposes.
OLC remains U.S.-focused, with the NDA under FDA review (resubmission expected by year-end 2025 after a manufacturing-related CRL).
No EMA filing or EU regulatory submission has been announced.
Ex-U.S. licensing deals are limited to Asia:Lee’s Pharmaceutical (China, Hong Kong, Macau)
Lotus Pharmaceutical (South Korea)

No partnerships, licensing agreements, or manufacturing arrangements for Europe/EU have been disclosed in press releases, SEC filings (10-K/Q), or investor materials.
Unicycive retains full rights outside its licensed Asian territories and may pursue EU opportunities post-U.S. approval, but nothing is confirmed currently.

Kiwi

[rosemountbomber]

Fred, I am not sure of your age, but I am just going to go along with the idea that you were familiar with the Flyers in their glory days.

Hence I assume you are familiar with Bernie Parent. I believe he passed away not too long ago.

Anyway, short story (sorry if not so short). I grew up in the eastern part of Montreal in a parish called Rosemount. There was a junior hockey team called the Rosemount Bombers. In 1963 - I was 11 at the time, my dad took me to a couple of playoff games that they played. Of course Bernie Parent was the goalie for the Bombers and they won the league playoffs. I believe they went on to lose in the provincial finals. But I remember he was stupendous in the games I saw. And, of course my handle here is based off of that team.