Editing Novartis (section)

=== AveXis data integrity ===
Having already received approval for Zolgensma in May 2019, on 28 June AveXis (a Novartis company) voluntarily disclosed to the FDA that some data previously submitted to the agency as part of the Biologics License Application (BLA) package was inaccurate. Specifically, the data manipulation related to an ''in vivo'' murine potency assay used in the early development of the product but the issue the FDA and wider community has taken is that AveXis was aware of the data manipulation as early as 14 March 2019, almost two months before the BLA was approved. To compound the problem in early August it emerged a senior manager sold almost $1&nbsp;million worth of stock immediately before the FDA probe became public on 6 August, but after the company had informed the FDA of the problem. As of September 2019, the FDA was still preparing its response to the scandal. {{citation needed|date=January 2021}}