FDA Approves Use of Commercially Manufactured GP2 in FLAMINGO-01
CEO Snehal Patel commented, “With our manufacturing investments in 2023 and 2024, and now the FDA’s review and approval to use the first commercial lot of finished GP2 vials in FLAMINGO-01, we have taken major steps to further de-risk the filing of a BLA in the US. We plan to start using these new GP2 vials in the coming weeks at all 40 US sites. We have 3 years of stability data to support the GP2 vial expiration date which may translate to the commercial expiration date of GP2 vials.”
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