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 ....
