RE: only an approval for a study12 Aug 2021 10:34
Agree, they have been saying this since at least February this year.
E.g. this from 9/2:
"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(TM), prior to commencement of the Phase 3 trial. "