27 August 2019 - Shortly before serious data problems surfaced in mid-March at a troubled Novartis unit, a Food and Drug Administration report noted the company had recently conducted an “extensive investigation” after finding errors and discrepancies in a preclinical test.
The agency apparently believed the difficulties had been rectified.
In a February 2019 report, FDA personnel noted that AveXis — the Novartis unit at the centre of a scandal over manipulating data for the gene therapy — uncovered problems with a so-called mouse assay.