FDA response for Type C Meeting – update31st August 2022 - 11:48 am
ImmuPharma plc (LSE : IMM), the specialist drug discovery and development company, announced on 7 July 2022 that its US partner for Lupuzor™ (P140), Avion Pharmaceuticals (“Avion”), had advised that it had received Type C Meeting confirmation from the Food and Drug Administration (“FDA”).
It was announced at that time that : the statement of purpose, objectives, and proposed agenda of the Type C meeting have been agreed with the FDA, that the FDA also agreed that written responses to the agenda items would be the most appropriate means for responding and that a face to face meeting was not required, and that the agreed date from the FDA for providing its written responses was 29 August 2022.
As of 30 August 2022, Avion has not yet received the written response from the FDA. The Company is in close contact with Avion and have been advised that the FDA is experiencing general delays in meeting response dates and that this is not specific to Avion and the Type C meeting for Lupuzor™ (P140). The Company will notify the market as soon as practicable once a response from the FDA has been received.
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.