Novo Nordisk Accepts Fine Regarding Timely Public Disclosure of FDA’s CRL

Nordisk A/S has accepted a DKK 500,000 ($89,610) fine imposed by the Public Prosecutor in a suit filed by the Danish Financial Supervisory Authority for not providing timely public disclosure of a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) concerning insulin products Tresiba and Ryzodeg in 2013.

In December 2013, the Danish Financial Supervisory Authority reported the company to the police for violating its obligation under Section 27 (1) of the Danish Securities Trading Act to disclose inside information as soon as possible. The reporting concerned the company's receipt of the CRL from the FDA in the evening of Friday February 8, 2013. In the letter, the FDA stated that approvals for the insulin products Tresiba and Ryzodeg could not be granted on the basis given in the CRL.

Novo Nordisk published the FDA's decision in a company announcement on Sunday February 10, 2013 following an investigation and evaluation of the implications and impact of the agency's decision. In the opinion of the Danish Financial Supervisory Authority and the Public Prosecutor, Novo Nordisk should have issued a company announcement on the Friday evening of February 8, 2013.

“Novo Nordisk is of the opinion that the company announcement was issued in a timely manner,” said the company in a statement. “The company maintains that even if the disclosure obligation could be said to apply already on the Friday evening, the company was entitled to delay public disclosure until the implications of the decision had been adequately analyzed, which they had been on the Sunday. However, for resource reasons Novo Nordisk's management has chosen to accept the fine to avoid a lengthy lawsuit. This will finally settle the case.”

Source: Novo Nordisk

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