While a form 483 isn’t good it doesn’t necessarily mean no fda approval….not an official kiss of death…🤞
As far as unisource goes….yes great partnership….I like it…
The "Unicycive and UniSource partnership" refers to a dedicated patient support program established by Unicycive Therapeutics (NASDAQ: UNCY) for individuals managing chronic kidney disease. UniSource is a branded reimbursement and access support hub operated by Unicycive Therapeutics. It serves as a centralized resource rather than a traditional corporate or joint business partnership. Key services provided by UniSource include: Benefits Verification: Helping patients and healthcare providers quickly determine insurance coverage. Prior Authorization Support: Assisting with the necessary paperwork to secure drug approvals. Financial Assistance Programs: Navigating co-pay support and other affordability options for eligible patients. Unicycive established the UniSource hub to support the commercial rollout of its lead investigational drug, oxylanthanum carbonate (OLC), which treats hyperphosphatemia in dialysis patients.