Dr Tim Franklin, Chief Operating Officer of ImmuPharma PLC (LON:IMM) joins Proactive London's Katie Pilbeam to discuss ImmuPharma's announcement that The US Food & Drug Administration (“FDA”) has confirmed 4th December 2020 will be the date for the Type ‘A’ Meeting Request, with Avion Pharmaceuticals, ImmuPharma’s licensing partner for Lupuzor™.
Dr Franklin says at the meeting, Avion together with the FDA will discuss key points and following the meeting the FDA will respond giving their guidance.
He says a conditional approval would allow the marketing of Lupuzor™ prior to the completion of the new Phase 3, based on the clinically significant data previously generated in the completed Phase 2 and 3 clinical trials to date.