Replies to post #2046 on UniCycive Therapeutics Inc (UNCY)

[Stumblebum]

That was the first I heard about it and is very encouraging….but was never given a feedback from IR….hopefully that happens next year also ….double win and revenue

[Whalatane]

Well they are certainly taking the initial steps for EU approval....getting the manufacturer approved ...which they apparently did .
Theres a lot of separate paper work , obligations etc for EU approval from what I've read .
The EU wants to see a supply of OLC established / in storage ? before approving for instance . So UNCY may not want to make that financial commitment until approved in the US .
Once approved in the US I expect things to ramp up fairly fast .
Resubmission success rate of 90% from my reading ....and if they get a PDUFA date in first half 2026 , and approval early June ...increases their chances of meeting the TDAPA qtly submission date in July .

My understanding of the TDAPA process

HCPCS Quarterly Submission Deadline and Corresponding TDAPA Submission


HCPCS Assigned Change Request Released/Effective (payment begins)
Early January Late April Early July (Quarterly Release)
Early April Late July Early October (Quarterly Release)
Early July Late October Early January (Annual Update)
Late September/Early October Late January Early April (Quarterly Release)

So we want approval in June 2026 so we can submit by early July 2026 , get approved for TDAPA in late October 2026 and start receiving full reimbursement in early Jan 2027


Kiwi