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Stumblebum

01/31/26 5:37 PM

#2575 RE: Whalatane #2574

That’s what I thought originally…..oh well just get the problem fixed!!

Wondering if the fda will do an actual on site visit in the coming months
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Denisk

01/31/26 6:28 PM

#2577 RE: Whalatane #2574

Who knows? I read somewhere that UNCY would have to build a new manufacturing line for their OLC at the subcontractor place in India and that they would fund the building of that line?
Why would they go through that and spend all this extra $$ if they have a secondary manufacturing vendor according yo AI from Google? Not clear...see attached:
"Unicycive Therapeutics (NASDAQ: UNCY) is the developer of Oxylanthanum Carbonate (OLC) and is managing the manufacturing and supply chain for the drug. Following a Complete Response Letter (CRL) in June 2025 due to manufacturing issues with their primary supplier, Unicycive has taken the following steps regarding their supplier/manufacturing partners:
Second Manufacturing Vendor (Backup): In response to the June 2025 CRL, Unicycive identified and utilized a second contract development and manufacturing organization (CDMO) to build redundancy into their supply chain.
Current Status: This second manufacturer has already produced OLC drug product, which was used in the New Drug Application (NDA) resubmission in December 2025.
Manufacturer Profile: The company indicates that this supplier has a "long history of successful FDA and international regulatory inspections".
Unicycive has not publicly disclosed the specific names of these third-party manufacturing vendors. They plan to commercialize OLC in the U.S. on their own rather than partnering with a larger pharmaceutical company"