At Novartis, who knew what — and when?

Yesterday's revelation that Novartis's much-vaunted gene therapy approval was based, in part, on falsified data was a shocking turn for a company in the midst of a self-described culture change. And for Vas Narasimhan, the CEO presiding over the Swiss company's evolution, the news raises uncomfortable questions.

The gene therapy is Zolgensma, acquired in an $8.7 billion deal meant to set the tone for Narasimhan’s tenure. According to the FDA, people inside Novartis became aware of data manipulation as early as March, but no one informed regulators until late June, more than a month after Zolgensma won approval.

Now Narasimhan, who has enjoyed a rising profile in an industry otherwise beset by criticism, needs to explain who knew what, and when.

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