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doi: 10.1111/j.1751-0813.2006.tb13119.x

McFadyenJDKieferJBraigDLoseff-SilverJPotempaLAEisenhardtSUet alDissociation of C-reactive protein localizes and amplifies inflammation: evidence for a direct biological role of C-reactive protein and its conformational changes

In September 2024 the BLA rolling submission process was completed and the BLA officially filed November 2024 with a PDUFA action date of September 5, 2025

It also recommends requesting a written coverage determination up front, supported by a letter of medical necessity and the specific medication and strength involved

[PubMed: 12364482] 321

DSIP and sleep induction mechanisms in mammalian models