Question · Q4 2025
Jon Cox (on behalf of Andrew Tsai) inquired about the ONAPGO supply capacity, specifically if the current supplier can meet the high end of the 2026 sales guidance ($70 million) and the data required for FDA approval of a second supplier.
Answer
Jack A. Khattar, President and CEO, confirmed the current supplier is planned to cover 2026 guidance and bridge to the second supplier, expected in 2027. He added that FDA approval for the second supplier would require stability data from new batches, not clinical studies, with an estimated 6-9 month review period.
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