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If you were wondering why Novartis (NVS) 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.


In an Aug. 23 letter to the agency, the executives who run AveXis — the Novartis unit at the center of the data scandal — went into copious detail about the effort to recount actions the company took upon learning about problems with a preclinical test known as a mouse assay. But they blamed the “highly complex” nature of their internal investigation for failing to tell the FDA about the problem any sooner.

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