When did Novartis know about the manipulated data?
AveXis personnel were aware of potential manipulation dating back to January 2018, learned of the specific problem on March 14, 2019 but waited until after the May 24 approval to open a formal inquiry — disclosing to the FDA on June 28, the gap at the heart of the controversy.
This is the heart of the controversy. The FDA said AveXis became aware of the issue before approval but did not tell the agency until afterwards. According to a Wall Street Journal report summarised by MedCity News, the company learned of the problem on March 14, 2019 but did not open a formal inquiry until May 15, and approval followed on May 24. A review of an FDA inspection report found AveXis personnel had been aware of potential data manipulation dating back to January 2018, with multiple instances observed by inspectors. Novartis CEO Vas Narasimhan said the company waited for the results of its internal investigation to provide the best information, not to secure approval first, and that scientists involved were being removed.