RE: Overdue update from Immupharma14 Apr 2021 15:08
This is the text on the 9th Feb rns
In response to the FDA input, Avion, in partnership with ImmuPharma, has plans to develop and validate a bioanalytical assay, to confirm the clinical pharmacology and pharmacokinetic ("PK") characterizations of Lupuzor™, prior to commencement of the Phase 3 trial.
A final guidance meeting between Avion and the FDA is being planned at which Avion will submit the methodology for assessing PK as part of the Phase 3 trial. This meeting, which is expected to take place in Q2, will also confirm previous submissions to FDA on the study design, clinical end points and approval process.