Posted by Michael Wonder on 24 Sep 2019
Novartis unit says FDA wasn’t told of data manipulation sooner because it was ‘highly complex’
25 September 2019 - If you were wondering why Novartis waited more than three months to notify the Food and Drug Administration about manipulated data for its pricey gene therapy, the answer is … the situation was complicated.
That, anyway, is the message delivered to the agency last month after the crisis erupted.
