Liquidia Corporation…announced today that it has filed litigation in the U.S. District Court of the District of Columbia (Case No. 1:24-cv-02428) that challenges the recent decision by the United States Food and Drug Administration (FDA) to grant 3-year new clinical investigation exclusivity (NCI exclusivity) to Tyvaso DPI.
Based on the US Supreme Court’s recent reversal of the “Chevron” doctrine, LQDA has a decent probability of prevailing against the FDA in court, IMO. (Absent the “Chevron” reversal, it’s unlikely that LQDA would have taken legal action against the FDA.)