Update on submission to the FDA for a Special Protocol Assessment (SPA) for the forthcoming international Phase III trial of Lupuzor™ in Lupus Patients11th September 2020 - 3:35 pm
ImmuPharma plc (LSE:IMM) (Euronext Growth Brussels: ALIMM), the specialist drug discovery and development company, announces an update on the announcement issued on 27 July 2020, in respect to the submission to the US Food & Drug Administration (“FDA”) of a SPA for Lupuzor™’s Phase III trial in Lupus patients.
In ImmuPharma’s discussions with Avion Pharmaceuticals (“Avion”), ImmuPharma’s licensing partner for Lupuzor™, Avion has confirmed that, whilst the review period by the FDA for an SPA request is normally up to 45 days (which has now passed), Avion has as yet not received a response from the FDA and as such the file is still in the review queue, due to the current workload at the FDA.
ImmuPharma will provide an update to the market as soon as Avion has received a response from the FDA and notified ImmuPharma.
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