ImmuPharma recently announced an update on the FDA meeting with Avion, ImmuPharma’s partner for Lupuzor™, on 4 December 2020 (Type ‘A’ meeting request). Based on the positive guidance and feedback from FDA, there is now a clear regulatory pathway to commence the Phase III trial in H2 2021, fully funded by Avion. As part of this feedback, Avion and ImmuPharma will develop and validate a bioanalytical assay in order to confirm the unique pharmacokinetic profile of Lupuzor™. This will be presente ....

15 Feb 2021
FDA Update: Lupuzor™ meeting paves the way for commencement of Phase III trial in H2 2021

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FDA Update: Lupuzor™ meeting paves the way for commencement of Phase III trial in H2 2021
ImmuPharma plc (IMM:LON) | 2.4 0 (-5.0%) | Mkt Cap: 7.92m
- Published:
15 Feb 2021 -
Author:
Dr. Navid Malik -
Pages:
5 -
ImmuPharma recently announced an update on the FDA meeting with Avion, ImmuPharma’s partner for Lupuzor™, on 4 December 2020 (Type ‘A’ meeting request). Based on the positive guidance and feedback from FDA, there is now a clear regulatory pathway to commence the Phase III trial in H2 2021, fully funded by Avion. As part of this feedback, Avion and ImmuPharma will develop and validate a bioanalytical assay in order to confirm the unique pharmacokinetic profile of Lupuzor™. This will be presente ....